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2019 CORPORATE CAPABILITIES AND CONTACT SERVICES DIRECTORY.

AbbVie Contract Manufacturing

1401 Sheridan Road

North Chicago, IL 60064-8524

Tel: +1 847-938-8524

E-mail: abbviecontractmfg@abbvie.com

Twitter: @AbbVieCM

LinkedIn: AbbVie Contract Manufacturing

Web: www.abbviecontractmfg.com

WHO WE ARE

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world.

AbbVie Contract Manufacturing

AbbVie Contract Manufacturing has been serving our partners for more than 35 years across ten of our manufacturing facilities located in both North America and Europe. Our contract development and manufacturing capabilities span both small and large molecule API including classical fermentation, chemical synthesis, biologies & ADCs. In addition to APIs, we are offering extensive experience and technical solutions in the area of drug product manufacturing which includes traditional tablet and capsule production with emphasis on DEA controlled drugs, potent and hot melt extrusion. Lastly, we can also package your product regionally and offer prefilled syringe manufacturing capabilities.

MAJOR MARKETS

By choosing AbbVie Contract Manufacturing, your team gets so much more than the typical CMO engagement. Alongside our state-of-the-art cGMP manufacturing facilities, AbbVie's partners gain integrated access to deep scientific expertise and processes that have successfully supported many small molecule and biologic medicines through to commercialization.

AbbVie's Contract Manufacturing capabilities span development and manufacturing services in, Drug Product, Potent, Hot Melt Extrusion, Fermentation, Prefilled Syringes, Biologies, ADCs, Packaging and Bulk Active Pharmaceutical Ingredients (APIs) across 10 production facilities in North America and Europe.

SERVICES OFFERED

Drug Product

AbbVie Contract Manufacturing offers a full range of drug product manufacturing from a global network of proven facilities. Clients' needs are met from development to commercial phases, with services supporting material procurement, process optimization, formulation, testing and stability.

Biologies

As a leading biopharmaceutical developer and manufacturer, AbbVie's scientific team offers expertise in process optimization, analytical characterization and cGMP manufacturing--supporting full development and commercialization of biologies.

Antibody Drug Conjugates (ADCs)

AbbVie demonstrates the capability to optimize success from innovation through commercialization including fill/finish. Customers also benefit from a simplified supply chain as both mAb and conjugation manufacturing are conveniently located at one site.

Hot Melt Extrusion (HME)

Experienced in development to commercial for difficult to formulate HME products. Extrusion capabilities from 9 mm to 70 mm.

Fermentation

AbbVie Contract Manufacturing offers world-class small molecule fermentation capabilities with working capacities in excess of 3,500m3 and expertise based on more than 60 years' in pharmaceutical fermentation.

Potent

AbbVie Contract Manufacturing offers a full range of potent capabilities for drug product and active pharmaceutical ingredients (HPAPIs), covering development phases to commercial equipment capable of handling potent classification of <1 [micro]g/m3.

Prefilled Syringe

We offer services incorporating development through commercial manufacturing at our state-of-the-art facility in Barceloneta, Puerto Rico.

Active Pharmaceutical Ingredients

AbbVie manufactures a wide range of compendia-grade active pharmaceutical ingredients and a variety of packaging sizes to meet the needs of companies seeking to procure these materials.

WWW.ABBVIECONTRACTMFG.COM

Accupac

Headquarters:

1501 Industrial Blvd.

PO Box 51200

Mainland, PA 19451-0200

Lakewood Facility:

1700 Oak Street

Lakewood, NJ 08701

Tel: 484-535-3880

Web: www.accupac.com

OUR PEOPLE

Accupac operates under the leadership of Bruce Wright, President; Mark Hinkel, Vice President of Sales and Marketing; Paulo Carreiro, Vice President of Quality Assurance and Regulatory Affairs; and Dave Mullen, Chief Financial Officer.

In addition, Accupac is backed by all of the hard-working Accupac employees who strive to exceed customer expectations every step of the way. Our workforce is one of the most diverse in the industry, employing talented people to handle all aspects of supply management, manufacturing, filling, packaging, and quality assurance testing.

WHO WE ARE

Accupac manufactures, fills, and packages a wide-range of consumer, over-the-counter, and personal care products in a cGMP and FDA-regulated environment using the highest quality ingredients. We specialize in active drug product ingredients and complex formulations.

Some of the world's largest brands leverage Accupac's capabilities as a competitive advantage. We act as a cost-efficient extension of your company and execute the highest level of production quality.

SERVICE OFFERED

Personal Care, Beauty Care, Hair Care Manufacturing

* Liquids, Creams, and Lotions

* Toothpaste, Whiteners, and Mouthwash

* Active Ingredients

* High Alcohol Content

* High Viscosity Products

Global Supply Chain Management

* Raw Materials Sourcing

* Microbiological Testing

* Manufacturing, Filling, and International Shipping Filling

* Bottles, Tubes, Jars, Pumps, and Pouches

* Hot-Fill

* Specialized Packaging

WWW.ACCUPAC.COM

Advanced Analytical Testing Laboratories

30 Silverline Drive

North Brunswick, NJ 08902

Tel: 732-253-7373

Fax: 732-253-7371

Web: www.advancedanalyticallabs.com

VITAL STATISTICS

Year Founded: 2008

WHO WE ARE

Advanced Analytical Testing Laboratories (AATL) is a contract testing facility located in the heart of New Jersey Pharmaceutical corridor. AATL has a strong, knowledgeable and hands on management team with extensive experience in the cGMP environment with regards to testing in Pharmaceutical and Biotechnology industry.

As leaders in our profession, we strive to deliver services of the highest quality that fully satisfy the expectations of our Clients. Protecting our Client interests is the foundation of our business along with Compliance to all Regulations that govern us. Quality is a corporate commitment within Advanced Analytical Testing Laboratories and is the individual responsibility of all employees. We want to project and live up to an image of professionalism and integrity.

SERVICES OFFERED

Listed below are some services that are provided by Advanced Analytical Testing Laboratories:

* Residual Solvents Testing per USP <467>

* Complete Monograph Testing per USP, EP and JP

* Water Testing (TOC, Conductivity, Heavy Metals, Nitrates, pH, etc.)

* Water System Validations

* Cleaning Validations

* Method Development and Validation per USP <1225> and ICH

* Wet Chemistry Testing

* Gas Testing per USP, EP and JP

* Container Testing

* Stability Storage and Testing Program

* Trending Reports

* Environmental Monitoring

* Microbiological Testing (Water and Products)

Please contact us with any questions or queries you might have in order for us to help you with your business.

WWW.ADVANCEDANALYTICALLABS.COM

Ajinomoto Bio-Pharma Services

(T): (858) 882-0123

(F): (858) 839-7329

Email: info@US.AjiBio-Pharma.Com

Website: www.AjiBio-Pharma.com

www.facebook.com/AjiBioPharma

www.linkedin.com/company/

ajibio-pharma-services/

twitter.com/AjiBioPharma

WHO WE ARE

Ajinomoto Bio-Pharma Services is a fuEy integrated contract development and manufacturing organization, with sites in Wetteren and Balen, Belgium and San Diego, California, USA, providing comprehensive process development services, cGMP manufacturing and drug product fill finish services of small molecule and biologic APIs and intermediates. Ajinomoto Bio-Pharma Services offers a broad range of innovative platforms and capabilities to rapidly scale from clinical and pilot programs to commercial quantities, including: Corynex technologies, oglionucleotide synthesis, antibody drug conjugations (ADC), high potency APIs (HPAPI), continuous flow manufacturing and more. Ajinomoto Bio-Pharma Services is dedicated to providing a high level of quality and service to meet our client's needs.

SERVICES OFFERED

Large Molecule Manufacturing:

One of the industry's top leaders in microbial biologic manufacturing, using patented technologies and providing impeccable quality

* cGMP Protein and Plasmid Production

* Microbial Cell Banking & Characterization

* Fermentation & Product Recovery

* Purification & Formulation

* Corynex[R] Protein Expression System

Highly Potent & ADC Services:

Ajinomoto Bio-Pharma Services offers dedicated production and laboratory suites for high containment ADC bioconjugates and highly potent compounds, as well as formulation and fill finish services

* Conjugation & Purification

* Fill & Finish

* Lyophilization

* Dedicated labs and manufacturing Oligo & Peptide Synthesis:

An industry leader in the synthesis of high quality, scalable, custom oligonucleotides and peptides

* AjiPhase[R] Synthesis Technology

* Fast Solid Phase Synthesis

Drug Product Manufacturing:

A leader in aseptic filling, offering a wide range of capabilities for vials and syringes

* Aseptic Formulation

* Aseptic Fill Finish

* Packaging, Serialization & Aggregation Services Development Services:

Our highly knowledgeable Process Development team will establish and characterize a robust manufacturing process to ensure consistent cGMP manufacturing performance

* Process Development

* Optimization & Scale Up

Product Quality & Analytical Services:

Our well-designed product quality and analytical programs work to ensure the success of your small and large molecule products through their life cycle

* On-Site Laboratories

* Phase Appropriate Analytical Method Development & Lot Release Testing

* ICH--Compliant Stability Programs

WWW.AJIBIO-PHARMA.COM

Alcami

Connected At Every Level

GLOBAL HEADQUARTERS

4620 Creekstone Drive

Durham, NC 27703

Tel: +1 800-575-4224

Website: alcaminow.com

VITAL STATISTICS

Years in Business: 40+

Number of Employees: 1000+

Global Locations: 10

WHO WE ARE

Alcami is a world-class contract development and manufacturing organization (CDMO) headquartered in North Carolina, with executive offices in Durham and Wilmington. With over 1,000 employees operating at ten global locations, our combined capabilities include API development and manufacturing, solid state chemistry, formulation development, analytical development and testing services, clinical and commercial finished dosage form manufacturing (oral solid dose and parenteral), packaging, and stability services. Alcami offers an exceptional end-to-end outsourcing opportunity as well as individualized development and manufacturing services that can be integrated for a less fragmented and faster pathway for your products. From early-stage development and scale up to integrated manufacturing and commercial success, our expertise ensures the best possible outcome for your product at every level.

CAPABILITIES

Alcami makes it easy for our partners to bring their products through the clinic to commercialization. We embrace an approach that integrates program, project, and process in a unique and highly effective way and where a product's potential is turned into reality day-after-day.

We meet all applicable local, state, and federal regulatory requirements, including current GMPs and country guidelines for the US, Canada, EU, and EU Member State regulatory bodies (eg, EMA, MPA, 1MB). We also incorporate international standards as part of the Quality Management System and meet expectations established by the USP, EP, and JP. We comply with all regulations and standards, including those regarding controlled substances (DEA), radioactive materials (NRC), environmental protection (EPA), child-resistant container-closures (CPSC), and employee safety (OSHA).

Alcami offers all phases of pharmaceutical development for small and large molecules through two laboratories located in Durham and Wilmington, NC. These facilities have supported more than 500 Investigational New Drug (IND) filings and over 50 NDAs, ANDAs, and NADAs since 1985. Two cGMP API facilities in Germantown, WI, and Weert, Netherlands, support Alcami's process development/scale up and clinical and commercial supply for customers worldwide. The Germantown facility is Alcami's Center of Excellence for API development and manufacturing site. The Weert facility serves as the company's Center of Excellence for Solid State Chemistry. Regional cGMP analytical laboratories in St. Louis, MO, Wilmington, NC, and Edison, NJ, provide comprehensive analytical testing solutions for Alcami customer's new drug entities and biopharmaceuticals, as well as generic drugs, chemicals, and animal health and medicated consumer health products. Alcami's cGMP drug product manufacturing facilities support preclinical, clinical, and commercial supply. Our Charleston, SC, facility is focused on processing parenteral products while the Wilmington, NC, facility provides oral solid dose manufacture. Both manufacturing sites are fully integrated with Alcami's packaging and distribution center.

Alcami has international sales offices in Tokyo, Japan, Cambridge, Massachusetts, and San Diego, California. The Japanese branch provides a home base for Alcami's local customers and serves Japanese companies interested in developing and manufacturing products for launch in the US.

ALCAMINOW.COM

Alpha Packaging

1555 Page Industrial Blvd.

St. Louis, MO 63132

Tel: 314-427-4300; 800-421-4772

Fax: 314-427-5445

E-mail: marketing@alphap.com

Web: www.alphap.com

VITAL STATISTICS

Year Founded: 1969

Key Personnel: Terry Moody, President and CEO; Matt Blake, Sr. VP of Operations; Brian McCarthy, Senior Vice President of Sales and Business Development; Jack Baily, Vice President of Distributor Sales; Adam Doane, Vice President of Direct Sales; and Marny Bielefelds Vice President of Marketing

WHO WE ARE

Alpha Packaging is a leading manufacturer of high-density polyethylene (HDPE), polyethylene terephthalate (PET) and polypropylene (PP) bottles and jars for the pharmaceutical, nutritional supplement, personal care, animal health, consumer chemical, and niche food and beverage industries. Sizes range from 1 ounce to 2 gallons, and include styles ideal for tablets and capsules; powders and granules; and liquids and lotions. We continue to work on sustainable packaging solutions, including bottles and jars with FDA-approved post-consumer resin (PCR) and lighter-weight options for the nutritional market. Alpha has seven manufacturing plants and one decorating facility in strategic locations across North America, as well as a manufacturing plant in The Netherlands. Alpha offers in-house tool-making capabilities, and can build everything from unit cavity molds to complete high cavity production tooling.

Technology, Patents, New Products:

Alpha has added substantial HDPE manufacturing capacity to the Northeastern US and introduced a new line of HDPE round packers called the HDPE Pharma Line. We have completed new molds for more than a dozen sizes of bottles, ranging from 50cc to 950cc. Sizes up to 300cc are manufactured on brand new equipment using the Injection Blow Molding process. Larger sizes are Extrusion Blow Molded on new equipment with brand new blow cavities. Production lines feature state-of-the art vision systems and leak detectors, and all bottles are manufactured with FDA approved resins and colorants. We have also expanded our stock lines of narrow neck PET bottles for liquid pharmaceuticals. In addition to our OTC pharmaceutical packaging, Alpha is also known as the leading manufacturer of wide mouth PET bottles for the rapidly-growing "gummy" sector. We have a full range of bottle and jar sizes in our stock portfolio, and can also build a custom jar, packer, oblong or cylinder for a minimal investment.

MAJOR MARKETS

* Nutritional Supplements

* Pharmaceuticals

* Personal Care

* Niche Food & Beverage

* Consumer Chemicals

SERVICES OFFERED

Major Products:

* Over 1,000 stock bottles and jars

* Custom styles in HDPE, PET and PP

* Custom-colored PET packaging

* High-quality container decorating on a variety of substrates Specialized Services:

Complete package design services, from the initial concept to the finished, decorated bottle. Free samples of stock items are available at www.alphap.com.

Global Capabilities:

Alpha operates one blow molding plant in The Netherlands, and can also provide distribution services throughout Europe, India, Australia and the Pacific Rim.

WWW.ALPHAP.COM

amri

Complex Science. Expert Solutions.

www.amriglobal.com

WHO WE ARE

AMRI, a global contract research and manufacturing organization partners with the pharmaceutical and biotechnology industries to improve patient outcomes and quality of life. With locations in North America, Europe and Asia, AMRTs team combines scientific expertise and market-leading technology to provide a complete suite of solutions in Discovery, Development, Analytical Services, API Manufacturing and Drug Product.

SERVICES OFFERED

* Early discovery research, next-generation technology platforms, complex medicinal and synthetic chemistry, biology and pharmacology services that support hit identification through candidate selection

* Centers of excellence that accelerate drug discovery innovation for the development of therapeutics

* Specialty compounds such as T3P[R], VPA and Oxa Acids that serve in a variety of innovative applications to yield high-quality products

* Extensive portfolio of more than 240 APIs

* Sterile and high potency APIs, steroids, generics, monobactams, boronic acids and controlled substances

* Global chemical development expertise for early stage compounds

* Custom synthesis and contract manufacturing expertise

* Technology expertise in specialty areas such as hydrogenation, fermentation, photocatalytic chemistry, bio transformation, industrial chromatography, flow chemistry and spray drying

* Analytical research and testing services, including solid state chemistry and container closure integrity testing

* Drug product experience spanning all compound categories for injectable, nasal and ophthalmic administration, and final dosage form flexibility across vials, syringes or dropper bottles

CAPABILITIES

Our complete suite of capabilities across the drug discovery, development and manufacturing continuum include:

DISCOVERY

Comprehensive discovery biology, synthetic and medicinal chemistry, ADMET and bioanalytical services

DEVELOPMENT

Chemical process R&D and continuous flow, manufacturing of non-GMP and GMP intermediates and clinical-stage APIs, biotransformations, enzymatic reactions, preformulation/ formulation and material science

ANALYTICAL SERVICES

Method development and validation, stability testing, quality control and spectroscopy services, particle engineering, material science, container qualification and testing, packaging and distribution testing, medical device and drug delivery testing, extractables/leachables and impurities detection, and microbiology

API MANUFACTURING

Chemical development and cGMP manufacture of complex APIs, including potent and cytoxic compounds, sterile APIs, steroids and controlled substances

DRUG PRODUCT

Integrated sterile dosage form expertise, including complex liquid and lyophilized formulation development, scale-up and cGMP supply

WWW.AMRIGLOBAL.COM

ANI Pharmaceuticals, Inc.

210 Main Street West

Baudette, MN 56623

Tel: 218-634-3500

Fax: 218-634-3540

E-mail: cmo@anlpharmaceuticals.com

Web: www.anipharmaceuticals.com

ANI Pharmaceuticals Canada, Inc.

400 Iroquois Shore Road

Oakville, Ontario, Canada LH61M5

Tel: 866-337-4500

Fax: 905-337-3539

E-mail: cmo@anipharmaceuticals.com

Web: www.wellspringcmo.com

VITAL STATISTICS

Year Founded: 2004

Number of Employees: 285

Annual Revenues: $200,000,000

Notable Event: Establishment of ANI Pharmaceuticals Canada, Inc. via acquisition of Wellspring Pharma Services Inc., Oakville, Ontario, Canada (August 2018)

Key Personnel:

Art Przybyl, President & CEO

Steve Carey, VP Finance & CFO

David Sullivan, VP Quality & Analytical Product Development

Jim Marken, SVP Operations & Product Development

Rob Schrepfer, SVP Business Development & Specialty Sales

WHO WE ARE

ANI Pharmaceuticals develops, manufactures, and markets specialty generic and branded prescription products. In three facilities with combined manufacturing, packaging and laboratory capacity totaling 274,000 square feet, ANI manufactures solid oral dose, powders, liquid solutions/ suspensions and topical products. Our strengths include potent compound manufacturing (hormones, steroids, and oncolytics), and controlled substance manufacturing/packaging. ANI provides contract manufacturing and packaging services for many of the largest and most respected pharmaceutical companies in the world.

MAJOR MARKETS

ANI Pharmaceuticals serves both the US and Canadian Pharmaceutical Industry.

SERVICES OFFERED

ANI Pharmaceuticals supplies contract manufacturing, packaging and laboratory support services including:

* Technology transfer

* Analytical testing

* Method development

* Microbiology

* Stability testing and sample storage under various conditions

* Method validation

* Process validation

* Cleaning validation

WWW.ANIPHARMACEUTICALS.COM

WWW.WELLSPRINGCMO.COM

Aphena Pharma Solutions, Inc.

1920 Fisk Road

Cookeville, TN 38506

Tel: 866-465-4506

E-mail: sales@aphenapharma.com

Web: www.aphenapharma.com

WHO WE ARE

Aphena Pharma Solutions is an industry leader providing contract packaging and manufacturing solutions for the pharmaceutical industry. With two separate FDA- and DEA registered sites in the U.S., Aphena is fully compliant with the FDA's current cGMPs. You can trust Aphena will handle all of your product needs to the standards you expect from a pharmaceutical contract service provider.

Aphena truly partners with clients to develop the solutions they need to succeed in a highly competitive marketplace. Aphena's strength lies in management's ability to understand clients'unique environments and create dynamic solutions. Aphena will continue to invest in technology, advanced packaging systems and rigorous cost controls to stay competitive, allowing cost savings over the life of agreements to keep our customers competitive.

MAJOR MARKETS

Pharmaceuticals (Rx, OTC,

Generic, Branded, Special Pharma),

Personal Care, Nutritional, Medical

Device and Animal Health

PRODUCTS HANDLING

* Solid Oral Dose (Tablets, Capsules, Softgels)

* Lotions

* Ointments

* Liquids

* Gels

* Creams

* Powders

* FDA registered 21 CFR parts 111, 820, 210, & 211

* ISO 9001:2008 (BSI registered)

* cGMP compliant

* EDI-ready

* DEA licensed (CII-CV)

* Serializing Ready (Optel & rfXcel)

* ISO 13485:2003

SERVICES OFFERED

Packaging Capabilities

Bottling Packaging (Plastic and Glass)

Blister Packaging (Thermoforming and Cold Forming)

Blister Carding (Heat Sealed)

OTC Stretch Carding

Vial Labeling and Kitting

Tube Filling (Plastic and Aluminum)

Metered Dose Pen Filling

Powder Pouching

Child-Resistant Packaging

Medical Device Packaging

Towelette and Swab Pouching

Sachet Filling

Wick Saturations, Nasal Inhalers

Labeling (Shrink Film, Standard, ECLs, Pressure Sensitive)

Clinical Packaging

Kitting Assembly

Custom Packaging Development

Manufacturing Capabilities

Liquids, Creams, Gel and Suspension-Based Products

Hot and Cold Blending

Aqueous and Solvent-Based

Flammable and Nonflammable

Various Viscosities

Pressurized Tanks for Suspensions

Light-Sensitive Blending Area

Value-Added Services

Onsite Extensive Analytical and Micro Labs

Test Method Development and Transfer

Cleaning Method Development

Stability Protocol Creation

Stability Testing

Full Product Transfer Support

Dedicated Project Managers

Kit and Tool Design

Engineering and Validation Support

Turnkey and Supply Chain Management

WWW.APHENAPHARMA.COM

Avara Pharmaceutical Services

3300 Marshall Ave.

Norman, OK 73072

Tel: +1 203-683-8024

E-mail: wlpasek@avara.com

Web: www.avara.com

VITAL STATISTICS

Year Founded: 2015

Number of Employees: 1,850

Headquarters: Norman, Oklahoma, USA

Manufacturing Sites:

Primary Manufacturing (OSD)

* Avion, United Kingdom

* Shannon, Ireland

Secondary Manufacturing (OSD)

* Aiken, South Carolina, USA

* Arecibo, Puerto Rico

* Norman Oklahoma, USA

Packaging & Distribution (OSD)

* Reims, France

Sterile Injectable Manufacturing

* Boucherville, Quebec, Canada

* Liscate, Italy

Center of Excellence--Sterile Injectable Development

* Boucherville, Quebec, Canada

WHO WE ARE

Avara delivers world-class contract manufacturing and technical services to the biopharmaceutical market. Avara delivers on its commitments in terms of scope, schedule, compliance and price. This is supported by nine manufacturing facilities in North America and Europe that were acquired from large pharmaceutical companies, have a proven record with blockbuster drugs, and historical competence evident through tenured personnel at every site.

MAJOR MARKETS

Avara has five manufacturing sites in North America and four in Europe, which offer manufacturing of drug substance and drug product in oral solid dosage forms and liquid / lyophilized steriles, including high potent capabilities. These manufacture drug substance and drug product for multiple blockbuster drugs, and produce and distribute products to more than 50 customers in over 100 global markets. The nine sites have a combined history exceeding 300 years.

SERVICES OFFERED

Avara offers primary manufacturing, secondary manufacturing and packaging. This includes cGMP development, scale-up and supply of APIs, including high potent APIs. Under secondary manufacturing, Avara offers clinical and commercial-scale solid dose and sterile drug product, including high containment capabilities. Packaging for clinical trial materials and commercial products is integrated with secondary manufacturing, and offers serialization to meet international requirements. Avara also provides development support and regulatory services, and has broad experience with tech transfers, commercialization, and manufacturing multiple blockbusters. All manufacturing adheres to operational excellence principles and a compliance-oriented quality program based on Lean Six Sigma methodologies.

Baxter BioPharma Solutions

One Baxter Parkway

Deerfield, IL 60015 USA

United States: 1-800-422-9837

International: 1-847-948-4770

E-mail: biopharmasolutions@baxter.com

Web: www.baxterbiopharmasolutions.com

VITAL STATISTICS

Year Founded: 1931

Number of Employees: 47,000

Approx. Annual Revenues: $10.6 Billion

COMPANY BACKGROUND

A global presence--Baxter has manufacturing sites across the globe in support of a diverse portfolio of delivery systems and manufacturing solutions.

Worldwide manufacturing expertise--The strength of Baxter's global network lies in efficient, quality cGMP manufacturing enabling Baxter's BioPharma Solutions business to deliver costeffective results built on best practices and operational excellence.

COMPANY DESCRIPTION

Backed by more than 85 years of Baxter innovation and expertise in parenterals, Baxter's BioPharma Solutions (BPS) business collaborates with pharmaceutical companies to support commercialization objectives for their molecules. BPS is a premier CMO with a focus on injectable pharmaceutical manufacturing designed to meet complex and traditional sterile manufacturing challenges with confidence of delivery, service and integrity. BPS can support your pharmaceutical needs with a broad portfolio of sterile fill/finish production capabilities and our reputation is built on the high-quality products we manufacture for our clients in a cGMP environment. From formulation and development, through commercial launch, our extensive, customized support services can guide you through marketplace complexities, helping you achieve the full potential for your drug molecule.

MAJOR PRODUCTS/SERVICES

Our Parenteral Delivery Systems include: prefilled syringes, liquid/lyophilized vials, cartridges, frozen premix systems, liquid premix systems, diluents for reconstitution, powder-filled vials, and sterile crystallization.

Our Drug Categories include: small molecules, biologies, vaccines, cytotoxics, highly potent compounds, ADCs (antibodydrug conjugates), and cephalosporins.

FACILITIES

A leader in sterile contract manufacturing--Our facility in Bloomington, Indiana USA serves client needs from clinical through commercial launch.

A world-class manufacturer of oncology products--Our facility in Halle/Westfalen, Germany offers dedicated clinical through commercial production.

A best-in-class aseptic solution manufacturer--Our facility in Round Lake, Illinois USA produces ready-to-use premixed drugs in proprietary bags.

A leading resource for parenteral product development--Our Lyophilization Center of Excellence is staffed with scientists who can assist with modification and formulas to maximize the potential of your lyophilized products.

WWW.BAXTERBIOPHARMASOLUTIONS.COM

Boehringer Ingelheim Biopharmaceuticals GmbH

Binger Strasse 173

55216 Ingelheim

Germany

Tel: +49 6132 77/0

Fax: +49 6132 72/0

E-mail: BioXcellence@boehringer-ingelheim.com

Web: www.bioxcellence.com

WHO WE ARE

The Boehringer Ingelheim Group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 181 affiliates and around 50,000 employees in 2017. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

The biopharmaceutical contract manufacturing business of Boehringer Ingelheim is represented by its brand Boehringer Ingelheim BioXcellence[TM]. As a leading biopharmaceutical contract manufacturer with more than 35 years of experience--Boehringer Ingelheim BioXcellence[TM] has brought more than 30 biopharmaceuticals products together with its customers to market. All types of services from mammalian cell line or microbial strain development to final drug production can be delivered within a one-stop-shop concept. Boehringer Ingelheim delivers services for pre-clinical development up to global market supply with a strong commitment to its customers at its manufacturing facilities for mammalian cell culture and microbial fermentation.

Boehringer Ingelheim has many years of experience in multiple molecule classes such as monoclonal antibodies, recombinant proteins, interferons, enzymes, fusion molecules and plasmid DNA. Furthermore, high-titer platform technologies for new antibody mimetic formats such as scaffold proteins and antibody fragments are available for the manufacture of customer products.

MAJOR MARKETS

Boehringer Ingelheim offers tailor-made contract development and manufacturing services to the biopharmaceutical industry, providing the entire production technology chain from DNA to fill and finish under one roof at its multiproduct facilities in Biberach (Germany), Vienna (Austria), Fremont (USA) and Shanghai (China).

Boehringer Ingelheim can secure product supply globally and throughout the entire product lifecycle--transferring customer projects at any stage, delivering to almost any scale, to any market and thereby makes outsourcing easy.

Boehringer Ingelheim's experience: Process development (including proprietary high-expression systems in CHO, E.coli and Yeasts) and manufacturing of biopharmaceuticals such as therapeutic proteins, monoclonal antibodies, antibody fragments, protein scaffolds, and plasmid DNA for clinical trials and global market supply.

SERVICES OFFERED

Boehringer Ingelheim BioXcellence[TM] represents services in biopharmaceuticals manufacturing.

Mammalian Cell Culture

* Clinical material capacities: flexible scales up to 2,000 L

* Production capacities: flexible scales up to 15,000 L

* Batch, Fed-batch and perfusion operations

* Stainless steel and disposables technologies

Microorganisms Fermentation

* Clinical material capacities: flexible scales up to 6,000 L

* Production capacities: flexible scales up to 6,000 L

* Batch or fed-batch fermentation

Downstream Processing

* Multi-product purification suites

* Explosion-proof unit and preparative HPLC

* Viral inactivation procedures

* Disposables technologies

Fill & Finish Services

* Up to 150,000 vials per batch aseptic filling

* Up to 150,000 syringes per batch aseptic filling

Opportunities for Boehringer Ingelheim's partners

* One-stop-shop from DNA to final dosage form

* Project start without initial investment at every step in the value chain

* Global supply of biopharmaceuticals up to large and commercial quantities

* Worldwide-licensed multi-product facilities

WWW.BIOXCELLENCE.COM

Brad-Pak Enterprises, Inc.

124 South Avenue

Garwood, NJ 07027

Tel: 908-233-1234

Fax: 908-233-9656

E-mail: info@brad-pak.com

Web: www.brad-pak.com

VITAL STATISTICS

Year Founded: 1985

Number of Employees: 20

Corporate Headquarters: Garwood, NJ Global Reach (Strategic Warehousing Partners)

WHO WE ARE

Brad-Pak Enterprises, Inc. is a family run business that understands the importance of what service means to a customer. We believe customer service is the most important piece of our business. We are a full-service distributor of glass and plastic bottles & jars, aluminum containers, many styles of closures CT, CRC, Snap, Dispensing), spray pumps, lotion pumps, UN packaging, and child resistant packaging. As a stocking distributor our customers can order small minimum quantities which is beneficial for stability testing, clinical testing, R&D or speed to market.

Brad-Pak Enterprises, Inc. encourages their employees to get involved in the industry. From attending conferences, lunches, dinners, webinar is how our employees stay on top of new trends, regulations, or news of imperative information happening today. We participate or are members of the following industry organizations:

New Jersey Packaging Executives Club (NJPEC) Cosmetic Industry Buyers and Suppliers (CIBs) Institute of Packaging Professionals (IOPP) Chemical Club of Philadelphia International Food Technology (IFT) Society of Cosmetic Chemists (SCC) Packaging Distributors & Manufacturers (PDM) National Association of Container Distributors (NACD) Women in Flavor and Fragrance Commerce (WFFC) World Perfumery Organization (WPO)

MAJOR MARKETS

* Pharmaceutical

* Nutraceutical

* Chemical/Industrial

* Personal Care/Cosmetic

* Research & Development

SERVICES OFFERED

* Customer Managed Inventory

* Decorating of Packaging Components

* Package Engineering Services

* Global Warehousing

* Liner Specifications

WWW.BRAD-PAK.COM

Cambrex

One Meadowlands Plaza

East Rutherford, NJ 07073 USA

Tel: +1 201-804-3000

E-mail: info@cambrex.com

Twitter: twitter.com/cambrex

LinkedIn: linkedin.com/company/cambrex/

Web: www.cambrex.com

VITAL STATISTICS

Year Founded: 1981

Number of Employees: 1,650

WHO WE ARE

Cambrex is the leading small molecule company that provides drug substance and drug product services across the entire drug lifecycle. Driven by passion, our pharmaceutical products, expertise and technologies accelerate our customers' small molecule therapeutics into markets across the world.

* We put all of our energy and experience into being your partner of choice

* We create value for customers through manufacturing excellence, reliable quality and innovative science

* Our people are the experts that our customers enjoy working with

We truly offer our customers an end-to-end partnership for the research, development and manufacture of small molecule therapeutics at every stage of the drug lifecycle.

MAJOR PRODUCTS/SERVICES OFFERED

Drug substance services:

* Custom development

* Custom manufacturing

* Generic APIs

Drug product services:

* Formulation development

* Clinical supply

* Custom manufacturing

* Packaging

* Analytical services

Specialist technologies include enzymatic biotransformations, high potency APIs, high energy chemical synthesis, controlled substances, hot melt extrusion, fixed-dose combinations and continuous processing.

MARKET SERVED

Cambrex has solved challenges for a wide variety of clients, from the world's largest pharmaceutical companies to emerging and established biotech companies, to specialty pharma and generic drug companies.

With over 35 years of small molecule development and manufacturing expertise, we are tried and tested in branded and generic markets for API and dosage form development and manufacturing.

TECHNICAL SERVICES

Drug substance development and manufacturing expertise in:

* Route selection

* Process development and optimization

* Contract process research

* Analytical development and validation

* Controlled substances

* Process and analytical validation

* Lab, kilo and pilot scale manufacturing

* Leading range of >more than 100 generic APIs

* Support for NDAs and 505(b)(2) NDAs for existing APIs

* Commercial scale cGMP manufacturing

Drug product development and manufacturing expertise in:

* Controlled substances

* Extended/modified release tablets/capsules

* Sustained release beads

* Micro and mini tablets

* Fixed-dose combination tablets

* Bi-layer tablets

* Film-coated tablets

* Solvent-based formulations

* Powders

* Liquids

* Creams

* Non-sterile ointments

* Sterile ointments

* Suppositories

Capsugel | Lonza Pharma & Biotech

412 Mt. Kemble Ave., Suite 200S

Morristown, NJ 07960

Tel: 888.783,6361

Web: www.capsuggl.com

Mail: solutions@lonza.com

WHO WE ARE

Capsule Delivery Solutions, part of Lonza Pharma & Biotech, is the leader in capsule-based solutions and services, proudly offering Capsugel[R] products. With the largest production and supply chain footprint in the industry, we provide the highest quality and deepest regulatory expertise to our 2,000 pharmaceutical customers, globally. Our unique combination of science, engineering, formulation and capsule expertise enables us to optimize the bioavailability, targeted delivery and overall performance of our customer's products. We partner with them in over 100 countries to create unique, high-quality and customized solutions that meet their needs and patients' evolving preferences.

HIGH QUALITY EMPTY CAPSULES

Immediate release: Coni-Snap[R] Gelatin, Vcaps[R] Plus, Plantcaps[R]

Targeted & Modified release: Vcaps[R] Enteric, DUOCAP[R]

Dry Powder Inhalation capsules: Gelatin: Coni-Snap[R] Gelatin and Coni-Snap[R] Gelatin-PEG, HPMC: Vcaps[R] and Vcaps[R] Plus

Preclinical and clinical development capsules: PCcaps[R], DBcaps[R], Colorista[tm]

Patient Centric capsules: Coni-Snap[R] Sprinkle

Life Cycle Management solutions: PressFit[R], X Press-Fit[R]

MARKET SERVED

Capsugel[R] creates, develops and manufactures a wide range of innovative dosage forms for the biopharmaceutical and consumer health & nutrition industries.

CONTACT DETAILS

For more information, email solutionsi@lortza.com. visit www.capsugel.com and follow us on Twitter. LinkedIn. YouTube and instagram.

Captek | Pharma

14535 Industry Circle

La Mirada, California 90638 USA

Tel: 657-205-0579

E-mail: Paul.Hwang@capteksoftgel.com

Web: captekpharma.com

VITAL STATISTICS

Year Founded: 1996

Number of Employees: Approx. 730

Key Personnel: Paul Hwang--Vice President, General Manager Gregg Komjati--Business Development Manager

WHO WE ARE

Captek Pharma is a division of Captek Softgel International, Inc., a privately-owned, a US FDA registered and audited, and 21 CFR part 210/211 dedicated, contract softgel manufacturer. We offer a state of the art, end to end manufacturing suites from encapsulation, drying, automated visual inspection, printing, and bulk packaging all within a single suite process train.

Captek Softgel International, Inc., a privately owned company, is a full-service contract manufacturer of custom dietary supplements formulations. Championing wellness worldwide since 1996, the company's focus is producing high quality pharmaceuticalgrade and nutraceutical products, bulk stock softgel capsules and supplements, 24/7, through innovative delivery systems utilizing rigorous quality assurance and quality control standards.

MAJOR MARKETS

Global distribution of bulk over-the-counter medications and pharmaceutical softgels.

SERVICES OFFERED

Captek Pharma is proud to offer a full range of contract manufacturing services including:

* Complete range of pharmaceutical formulation development services, analytical methods development, methods and process validation, stability studies, raw material and finished product testing

* Industry expertise--experienced scientific staff with years of pharmaceutical industry experience in product formulation and development

* Knowledgeable and customer centric service team

CAPTEKPHARMA.COM

Catalent Pharma Solutions

14 Schoolhouse Road

Somerset, NJ 08873

Tel: 1-888-S0LUTI0N

(+1 888-765-8846)

E-mail: solutions@catalent.com

Web: www.catalent.com

WHO WE ARE

Catalent is the leading global provider of advanced drug delivery technologies and development solutions, providing worldwide clinical and commercial supply capabilities for drugs, biologies, and consumer health products. With over 85 years of experience, Catalent has the proven expertise and flexible solutions at the right scale to bring more customer products to market faster, enhancing product performance, and ensuring reliable supply.

We serve more than 1,000 innovator customers--both established and emerging--in over 80 markets, including 90 of the top 100 branded drug marketers, 21 of the top 25 generics marketers, 24 of the top 25 biotechs, and 23 of the top 25 consumer health marketers globally. We manufacture more than 73 billion doses of nearly 7,000 products annually, which equates to approximately 1 in 20 doses taken each year by patients or consumers around the globe.

Our significant intellectual property includes over 1,200 patents and patent applications, and our team, including more than 1,800 talented scientists, help introduce more than 150 new products to market every year. Supporting this innovation is our team of 1,400 quality and regulatory experts, who ensure compliance and safety. Catalent was subject to 53 regulatory audits and over 400 customer and internal audits in 2016/17.

We have made significant investments to establish a global manufacturing network, and today employ over five million square feet of manufacturing and laboratory space across five continents.

Whether you are looking for a single, tailored solution or multiple answers throughout your product's lifecycle, we can improve the total value of your treatments--from discovery to market and beyond.

Catalent. More products. Better treatments. Reliably supplied.[TM]

TECHNOLOGY HIGHLIGHTS

With our wide range of expert services--including analytical, biologies, pre-formulation and formulation--we drive faster, more efficient development timelines and produce better products. These include:

* Early Development with centers of excellence in the US and Europe

* OptiForm[R] Solution Suite for rapid, optimized dose form development

* Unique delivery technologies: including OptiShell[R] capsules, Zydis[R] ODT, modified release and OptiMelt[R] hotmelt extrusion, as well as inhaled and injectable dose forms

* Catalent Biologies--advanced technologies and tailored solutions for biologic and biosimilar development from DNA to commercial supply. Comprehensive analytical solutions, biomanufacturing, and finished product supply in liquid and lyophilized vials, prefilled syringes, and cartridges

* GPEx[R] cell line engineering technology for advanced cell expression

* SMARTag[R] protein conjugation technology; precision design of next-generation biologic therapies

* Catalent RP Scherer Softgel is a global leader in innovative oral and topical softgel technologies. In the last 25 years, nearly 90% of NCEs approved by the FDA have been developed by us

* Catalent's Clinical Supply Solutions help solve trial challenges by reliably supplying studies of all sizes and complexities. With innovative, flexible solutions, modern global facilities, and more than 25 years' experience in supply chain management across 5,000+ studies globally

WWW.CATALENT.COM

Chartwell Pharmaceuticals, LLC

77 Brenner Drive | Congers, New York 10920

+1 845.268.5000x506 | www.chartwellpharma.com

Lance.Kann@chartwellpharma.com

WHO WE ARE

Chartwell Pharmaceuticals, is a US-based, full-service manufacturing, packaging, and related supply chain services organization located in Rockland County, New York, just north of New Jersey and close to New York City. The highest quality pharmaceutical products have been produced in our cGMP compliant facility for over twenty years. Our rooms are large, ceilings are high, and facilities are pristine. Our exceptional hands-on leadership team and technical staff bring decades of pharmaceutical industry experience in manufacturing and analytical services for developing, transferring, changing, launching and/or supplying products. Chartwell Pharmaceuticals is proud to be manufacturing "Made in the USA" products for our global clients and partners.

In our corporate development strategy as a fully integrated Pharmaceutical company, we have established Chartwell Actives, a Portugal-based team dedicated to the development and optimization of active pharmaceutical ingredients using fermentation, biotechnology, downstream processing, and chemical synthesis. We have also launched Chartwell Labs, an Israel-based team focused on complex, creative, and novel projects, as well as formulations and analytical development support. Together we can readily meet the demands of our clients and partners throughout the life cycle from API development to formulation trials to clinical supplies to full scale commercial batches.

SERVICES OFFERED

Chartwell Pharmaceuticals provides prescription solid dosage (tablets, capsules and powders) manufacturing and analytical services. Our manufacturing facility produces millions of doses every day. With 25 production suites tuned to high volume and large batch size output, and with an annual production capacity of over 3 billion dosage units with available surge capacity, we can meet most any need. Manufacturing capabilities include high and low shear granulation, roller compaction, fluid bed processing, tray ovens, small-to-large size blending, Fette and Kikasui compression, Bosch encapsulation with weight checking, and aqueous film-coating. Packaging can fill solid dosage in bottles from 25cc to 1500cc, as well as powders for oral suspension in glass or plastic. The Analytical Services laboratory covers all aspects of wet and dry chemistry for raw materials and finished dosage. Stability Services covers all ICH storage conditions and related testing.

CONTACT US TODAY TO LEARN MORE--WE CAN HELP!

ChartwellPharma.com

Chemic Laboratories, Inc.#

480 Neponset Street, Bldg. 7

Canton, MA 02021

Tel: 781-821-5600

Fax: 781-821-5651

E-mail: lcw@chemiclabs.com

Web: www.chemiclabs.com

VITAL STATISTICS

Year Founded: 1998

Number of Employees: 45

Key Personnel: Scott A. Goodrich, chief financial officer; Joseph P. St. Laurent, chief scientific officer

WHO WE ARE

Chemic Laboratories, Inc. is a full service cGMP/GLP contract analytical chemistry laboratory. Chemie provides an array of R&D and cGMP contract testing services including; Extractables/ Leachables analysis, BPOG Protocol Testing, CMC Method Development & Validation, Quality Control analysis, Release testing, Raw Materials analysis, Compendial testing, Organic Synthesis/Formulation Development & ICH Stability testing.

Chemie continually strives to exceed the requirements and expectations of our sponsors. We are committed to providing quality services to our clients in support of their product development needs.

MAJOR MARKETS

Chemic Laboratories, Inc. is located in Canton, Massachusetts and provides cost-effective outsourcing solutions to a broad spectrum of global clients in the pharmaceutical, medical device and biopharmaceutical industries. We are committed to developing long term strategic alliances with our clients. Chemic offers the ideal blend of expertise and experience that is critical to our clients'success.

SERVICES OFFERED

Chemic Laboratories, Inc. offers a wide array of cGMP/GLl contract testing services including:

* Quality Control Testing of raw materials, API's and finished products

* CMC Method Development & Validation

* Degradate Quantitation

* Extractables and Leachables Analysis

* BPOG Protocol Testing

* Container Closure Assessment

* ICH Storage and Accelerated Stability Studies

* cGMP/GLP Method Development and Validation

* Organic Synthesis and Formulation Development

WWW.CHEMICLABS.COM

CMIC Group

1-1-1 Shibaura, Minato-ku,Tokyo 105-0023, Japan

E-mail: information@cmic.co.jp

Tel:+81-3-6779-8000 (HQ)

Tel: +1-609-395-9700 Ext. 106 (US)

www.cmicgroup.com/e

Company Description

CMIC stands for Current Medical Information Center. In 1992, Dr. Kazuo Nakamura founded CMIC as the first Clinical Research Organization (CRO) in Japan.

To enable pharmaceutical companies to develop better medicine sooner, we expanded our solutions to include contract development and manufacturing (CDMO), site management (SMO), contract sales (CSO) and established an innovative pharma model (IPM) to bring highly desired treatments to the Japanese market. We strive to be a Pharmaceutical Value Creator (PVC), spanning our services across the entire drug development value chain, and meeting our customers' needs in the U.S., Japan and broader Asia.

Services and Capabilities

Unique one-stop service partner in Japan

CMIC Group is the only preclinical to post-marketing end-to-end solution partner in Japan. If you wish to conduct a clinical study in Japan, we will serve as your required In-Country Clinical Caretaker (ICCC). For Japanese market entry, we act as your Marketing Authorization Holder (MAH) or connect you with a strategic licensing partner. We will share our expertise as your regulatory consultant to provide solutions for pharmaceutical products, medical devices, regenerative medicine and in vitro diagnostic products.

Providing speed and flexibility for drug development needs in the U.S.

CMIC Group provides oral solid drug development & manufacturing solutions from New Jersey and bioanalysis testing services from Chicago. Based on these services and our broad offering in Japan and Asia, we can help you expand into the U.S. market. We also help new and growing companies meet timelines and scale-up for commercialization utilizing our innovative technology and customer-focused dedication. Let us help you achieve your next milestones faster.

Coating Place, Inc.

200 Paoli Street

P.O. Box 930310

Verona, Wi 53593

Tel: 608-845-9521

Fax: 608-845-9526

E-mail: info@coatingplace.com

Web: www.coatingplace.com

VITAL STATISTICS

Year Founded: 1976

Number of Employees: 200

Key Personnel: Tim Breunig--President & CEO Harlan Hall--Founder & CTO Corey Uselman--Director of Business Development Fred Schulze--VP of Technical Sales

WHO WE ARE

Coating Place is the leading Wurster fluid bed coating services supplier in the industry with over 40 years of experience in formulation development, technical transfer and commercial manufacturing. We offer unsurpassed knowledge and expertise in the microencapsulation of powders, granules and crystals, as well as many other manufacturing techniques. We have the capability to handle a wide range of project requirements from laboratory services, feasibility studies, modified release properties, particle engineering and much more. Our status as an FDA and EMA approved GMP and CLP contract manufacturing facility ensures the highest quality products available. We operate out of two manufacturing locations, providing roughly 300,000 sq. ft. of modern facility space for Wurster coating and support services such as tableting, capsule filling, laboratory testing and warehouse storage.

MAJOR MARKETS

Coating Place provides contract development and commercial manufacturing of pharmaceutical, nutraceutical and specialty chemical products to the US and European markets.

SERVICES OFFERED

Coating Place provides a complete range of services from formulation development, feasibility studies, technology transfer, scale-up, to commercial manufacturing with full GLP analytical support. Formulation services include controlled oral delivery such as enteric, delayed, or extended release coating using our Oradel[R] Platform. Other coating applications include moisture or oxygen barrier and taste masking. CPI has extensive expertise and numerous patents in the area of controlled release using ion exchange technology. Our scientists have successfully developed a wide range of formulations and applied them to an equally wide range of core materials.

WWW.COATINGPLACE.COM

CONSUMER PRODUCT TESTING[TM] COMPANY

70 New Dutch Lane

Fairfield NJ 07004-2514

+1 973 2447535

sales@cptclabs.com

www.cptclabs.com

VITAL STATISTICS

Key Personnel

Mel Weiss

Chairman, Board of Directors

Craig Weiss

President & Co-CEO

Lon Weiss

Chief Operating Officer & CO-CEO

Joy Frank

Executive Vice President

William Neumann

Vice President,

Quality Assurance & Regulatory Affairs

Michael Caswell, Ph.D.

Vice President, Clinical Evaluations

Keith Goins, Ph.D.

Director, Microbiology Services

Leslie Eberspeacher

Account Manager

Julian Harris

Account Manager

Joseph Schnitzlein

Account Manager

Gy Rinaldi

Account Manager

MAJOR MARKETS

* Pharmaceutical/OTC

* Medical Devices

* Dietary Supplements

* Specialty Chemical

* Personal Care/Cosmetic

MAJOR SERVICES

Analytical Testing

* Raw Materials, Finished Product and Containers

* Validation and Stability

* Low Level Contaminates and Impurities

* NDA, ANDA and 51 OK Support

* "Free-of" Claims Microbiology Testing

* Microbial Limits, Preservatives, Antibiotics

* Environmental Monitoring, Water Testing, Sterility Testing

* FDA BAM Chapter 23--Cosmetic Testing / Import Detentions In-Vitro Toxicology Safety Testing

Consulting Services, GMP Audit Clinical Safety and Efficacy (Claims)

* HRIPT, 48 hrs. Cumulative Patch Testing

* Bioinstrumentation: AEVA3D-HE, Visia CRTM[TM], PRIMOS 3D[TM]

* MoisturizationA/iscoelasticity/TEWL

* "Dermatologist/Ophthalmologist Tested" Claims

* Sensitive Skin (Facial Sting) Studies

* Acnegenicity/Comedogenicity Studies

* Safety In-Use & Exaggerated Use Studies

* Visual & Tactile Expert Grading and odor evaluation

* Custom Protocol Development to meet your needs Antiperspirant Testing

Sunscreen (Photobiology) Testing

* FDA Methods

* ISO Methods

SPECIALIZED SERVICES

* CPTSM provides a unique 'one-stop-shop1 testing program, including our regulatory audit team, for multiple international industries utilizing skilled technical personnel performing regulated/ research studies.

* Consulting services for pharmaceutical, nutritional and cosmetic industries. This includes the creation, assessment or improvement of quality systems; preparation of regulatory filings; vendor and facility audits; and general compliance and regulatory consulting services.

* AEVA3D-HE with Visio-4D--Cutting edge bioinstrumentation for clinical claims is a high resolution 3D solution, high demanding measurement system for skin topography, face topology and body morphology changes.

GLOBAL CAPABILITIES

CPTSM provides testing programs and consulting services for companies on six continents under FDA/EPA/ISO and other regulatory guidelines.

NEW TO OUR PORTFOLIO

* CPSC Phthalates and Lead

* Elemental Impurities Testing per USP <232>, <233>

* Expanded Heavy Metals capacity

* Expanded GC capacity

* Expanded HRIPT capacity

* New Bioinstrumentation: Eotech AEVA3D-HE with Visio-4D

WHO WE ARE

Consumer Product TestingSM Company (CPTSM) is a world-renowned, global leader in the contract laboratory testing of pharmaceuticals, cosmetics, personal care and specialty chemicals. Since 1975, we have assisted clients with their testing needs from conception to completion.

The services offered include analytical chemistry, microbiology, in-vitro safety, consulting services, clinical safety and performance claims validation and photobiology, complying with GMP/GLP/GCP regulations.

CPTSM performs clinical trials to support product skin claims to the highest scientific standards while producing comprehensive reports and analysis that will satisfy regulatory bodies.

Our quality assurance and regulatory staff monitors compliance to our internal SOPs and applicable regulations. Our in-house validation engineers and metrology team monitors, calibrates and validates equipment to the highest standards.

With a staff of over 150 personnel, CPTSM can provide the technical expertise required to guide clients through a product's testing requirements to meet regulatory requirements in both national and global markets.

Board Certified physicians in dermatology, ophthalmology, pediatrics, gynecology and dentistry work with our staff to ensure accurate, statistically significant, and clinically relevant results. Our scientists continue to develop new, and improve existing, testing methods to allow your products to stand out.

Well-known for our superior customer service, we become an integral part of our clients' teams, providing timely, reliable, accurate and reproducible results.

CPL (Contract Pharmaceuticals, Ltd.)

7600 Danbro Crescent

Mississauga, Ontario, Canada

L5N 6L6

Tel: 905-821-7600

Web: www.cplltd.com

VITAL STATISTICS

Year Founded: 1991

Number of Employees: 400+

Key Personnel: Ken Paige, CEO; Jan Sahai, VP-Busines: Development; Rajiv Mathur, VP-Product Development; Erik; DeRango, VP-Operations; David Tyler, Director, Busines: Development

WHO WE ARE

CPL is a leading contract developer and manufacturer (CDMO) of non-sterile liquid and semi-solid pharmaceutical products including creams, ointments, gels, lotions, and non-sterile solutions, suspensions, and nasal sprays. With a strong record of regulatory compliance, exceptional customer service and product expertise, CPL is the trusted choice for your pharmaceutical outsourcing projects. By offering turn-key services--from development to commercial production--CPL creates strategic relationships with our customers that result in long-term success. We have been in business for more than 25 years and have grown to become a trusted partner to our customers.

CPL has two facilities registered with U.S. FDA and Health Canada--140,000 square-foot development and manufacturing facility and a 15,000 square-foot analytical/QC testing lab. CPL opened its new analytical lab in 2015, very close to our manufacturing site. CPL's facilities have self-identified as generic sites under the US GDUFA and are in good standing. CPL has completed preparations and is able to support product serialization.

MAJOR MARKETS

CPL serves large, mid-size, and specialty branded and generic pharmaceutical customers in North America, Europe, India, and Asia Pacific. The majority of the products we produce are destined for the North American market, but we also easily support products for Europe because of the mutual recognition agreement between Canada and the European Union.

SERVICES OFFERED

From product development to commercial manufacturing all under one roof.

Topical semi-solid and non-sterile liquid formulation and product development services

* New formulations, formulation and process optimization, analytical methods, clinical trial supplies manufacturing, and commercial scale-up

* Expertise in NDA, ANDA, 505(b)2, and OTC products

Commercial manufacturing and packaging services

* GMP manufacturing of non-sterile liquid (suspensions, solutions, nasal sprays) and semi-solid (gels, lotions, creams, ointments) products

* Mixing vessels and tanks from 20kg to 5,000kg

* Packaging includes metal and laminate tubes, plastic and glass bottles and jars, nasal sprays, foil sachets, and secondary packaging

* Manufacturing and filling of high-alcohol containing materials, light or oxygen sensitive products, corticosteroids, and hormone products.

Analytical R&D, product stability, and product (QC) testing services

* Elemental Impurities testing

* Skin testing lab including IVRT, IVPT, and skin disease models

* Method development and validation, cleaning validation, method transfers, and special studies

* Routine GMP product testing of raw materials, bulk and finished products, and microbiological testing

* ICH stability studies

WWW.CPLLTD.COM

CoreRx, Inc.

14205 Myerlake Circle

Clearwater, FL 33760

Tel: 727-259-6950

E-mail: businessdevelopment@corerxpharma.com

Web: www.corerxpharma.com

VITAL STATISTICS

Year Founded: 2006

Number of Employees: 165+

Approximate Annual Revenues: Over $16 Million

Key Personnel:

Todd Daviau--President & CEO

Bill Reid--Executive Director & COO

Mark DaFonseca--Executive Director & CBO

Bob Berg--Chief Financial Officer

Mohammad S. Shekhani, Ph.D.--Executive Director Quality Compliance

Janice Cacace, Ph.D.--Senior Director of Formulation Development

Eric Primelles--Director of Analytical

Simon Daw--Manufacturing Manager

WHO WE ARE

CoreRx, a Contract Development Manufacturing Organization (CDMO) with capabilities to support clinical--niche commercial manufacturing, offering state of the art facilities to support your supply chain needs. Our integrated offerings provide comprehensive services for the development, manufacturing and testing of solid, liquid and semi-solid dosage forms.

The art of drug product development is the core of what we do. We differentiate ourselves by mixing highly experienced scientists with a wide range of technologies to deliver optimal solutions to meet our clients' needs. From simple formulations to complex, delayed or targeted release dosage forms, our solutions maximize client investments, shorten development time and reduce overall costs.

At CoreRx, you bring us your formulation challenge and we will supply the right ingredients to ensure your product reaches its maximum potential.

MAJOR MARKETS

North America and Europe

SERVICES OFFERED

* Accelerated Stability Studies

* Analytical Method Development

* Analytical Method Validation

* API Particle Size Technologies

* Preformulation Studies

* Formulation Development:

* Tablets (micro to muliti-layer)

* Capsules (powder or multiparticulate)

* Oral Solutions/Suspensions

* Powders

* Suppositories

* Creams, Gels, Ointments & Lotions

* Immediate or Modified Release Profiles

* Combination Products

* Clinical Trial Manufacturing

* Niche Commercial Manufacturing

* Packaging (Bottles, Blisters, Sachets)

* GMP Release Testing

* GMP ICH Stability Studies

* DEA License (schedule II-V)

WWW.CORERXPHARMA.COM

CORDENPHARMA

Inquiry: www.cordenpharma.com/contact-us/

Web: www.cordenpharma.com

VITAL STATISTICS

Year Founded: 2006

Number of Employees: 1,600

Number of Facilities: 9 GMP /1 R&D Labs

Approximate Annual Revenues: 345 MM [euro]

WHO WE ARE

CordenPharma is your full-service partner in the Contract Development & Manufacturing (CDMO) of APIs, Drug Products and associated Packaging Services. Through a network of fully-inspected cGMP facilities across Europe and the US organized under five technology platforms--Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology Small Molecules, and Antibiotics--CordenPharma expert; translate complex ideas, projects and processes at any stage of development into high-value products.

SERVICES OFFERED

CordenPharma',s Technology Platforms utilize state-of-the art cGMP facilities to provide a full range of CDMO services for custom manufacturers, generic innovators, and pharmaceutical / biotechnology companies from development to commercial supply.

Peptides. Lipids & Carbohydrates

* Synthetic Peptide API Production

--Solid / Liquid-phase, Hybrid Synthesis

--cGMP & non-cGMP

* Synthetic Lipids

* Carbohydrates

Sterile Injectables

* New Development & Commercial Suites for Aseptic Filling with >60.000 units per day (Pre-filled Syringes, Liquid or Lyophilized Vials)

* Packaging, Labeling & Logistics

* Sterile Emulsion Technology

* Large Pre-Filled Syringes

* Clinical Trial Services

Highly Potent & Oncology

* API Development & Commercial Manufacturing (SafeBridge Category 4, OEL <1 ng/m3)

--High Containment for Cytotoxic & Cytostatic APIs

--Low Volume Clinical Batches to Commercial Manufacturing

--Highly Potent Small Molecules & Peptides (solid & solution phase)

* Oral Solid Dose

--Highly Potent Drug Products, from Dev (100g) to Commercial Scale

--Coated & Uncoated Tablets & Hard Gelatin Capsules

--Packaging (blisters & bottles)

--Serialization & 2D Data Matrix Coding

* Injectables

--Highly Potent, Cytotoxic & Cytostatic Products

--Sterile Liquid & Lyophilization

--Packaging & Serialization

Small Molecules

* Development & Commercial Manufacturing

--Intermediates

--APIs & Excipients

--Clinical Supply from Phase I-III

* Proprietary & Generic Advanced Intermediates & APIs

Antibiotics

* Non-segregated

--Sterile Drug Products

--Primary & Secondary Packaging

* Segregated

--Cephalosporins & Penicillins

--Monobactams

--Primary & Secondary Packaging

FACILITIES

CordenPharma Bergamo--Italy

CordenPharma Boulder--USA

CordenPharma Brussels--Belgium

CordenPharma Caponago--Italy

CordenPharma Chenove--France

CordenPharma Colorado--USA

CordenPharma Latina--Italy

CordenPharma Plankstadt--Germany

CordenPhanna Switzerland--Switzerland

WWW.CORDENPHARMA.COM

Cytovance Biologies, Inc.

800 Research Parkway, Suite 200

Oklahoma City, OK 73104

Tel: 405-319-8310

Fax: 405-319-8339

E-mail: info@cytovance.com

Web: www.cytovance.com

VITAL STATISTICS

Year Founded: 2003

Number of Employees: 280

Key Personnel: Yan Wang, CEO; Jesse McCool, SVP of R&D Services; Mike O'Mara, SVP of Manufacturing; Eddie Miranda, VP of Quality; Naomi Seresinhe, VP of Program Management; Joyce Johnson, VP of Human Resources; Lonnie Barish, VP of Business Development & Marketing

WHO WE ARE

Cytovance Biologies, Inc. specializes in the production of therapeutic proteins and antibodies from both mammalian cell culture and microbial-based systems. Cytovance provides cell line development, process development and cGMP biologies manufacturing. We place significant value on customer service through our culture of responsibility and reliability.

MAJOR MARKETS

Cytovance Biologies serves Biotech and Pharmaceutical industries globally.

SERVICES OFFERED

Cytovance offers a comprehensive range of development and cGMP manufacturing services for clinical through commercial the biopharmceutical industry, including:

Cell Line Development

* Microbial and Mammalian

Process Development

* Cell Culture Process Development

* Pre-formulation Studies

* Microbial Strain Development

* Fermentation Development

* Recovery and Purification Development

* Analytical Method Development, Qualification and Validation

* Process Characterization

cGMP Manufacturing

* cGMP cell banking (microbial and mammalian)

* Cell Culture production from 50L-1,000L

* cGMP Microbial Manufacturing up to 1000L

* Process Validation

Support Services

* Project Management

* ICH Stability Testing

Facilities

Company Background Cytovance[R] Biologies was founded in 2003 based on the client-side experiences of the executive team of Novazyme Pharmaceuticals. In order to develop alpha glucosidase and other recombinant enzyme replacement therapies it was necessary to access, contract with and manage numerous service providers. These included contract manufacturers and consultants providing cell banking, analytical development and testing services, fill/finish, validation and numerous ancillary services. After the successful sale of Novazyme Pharmaceuticals to Genzyme Corporation in 2001 and a period of transition during which members of the Cytovance team held executive positions at Genzyme, the team drew on its strong client-side experience, founding Cytovance Biologies. Our business model was designed from the bottom-up with the technical and business needs of the client in mind.

Cytovance occupies 140,000 sq. ft. of manufacturing space. These include segregated Mammalian, Microbial, and Flex suite manufacturing suites with an independent state of the art warehouse. All of these facilities are custom-designed for multiproduct cGMP production of biopharmaceuticals.

Our 50,000 sq. ft. mammalian facility features production in cell culture suites utilizing single-use bioreactors at 250L, 1,000L and 2,000L scale and Stainless Steel bioreactors at 100L, 500L scales. Recovery and purification is undertaken in adjacent independent purification suites. An adjacent facility houses automated vial filling operations, process and analytical development laboratories, and administrative offices. Microbial manufacturing capabilities include cGMP fermentation processes at 10L, 200L, 300L and 1,000L scales and downstream recovery process suites with 2 x 5000L refolding tanks.

Dalton Pharma Services

349 Wildcat Road

Toronto, ON M3J 2S3 Canada

Tel: 416-661-2102; Toll Free: 1-800-567-5060

Fax: 416-661-2108

E-mail: chemist@dalton.com

Web: www.dalton.com

VITAL STATISTICS

Year Founded: 1986

Number of Employees: >100

WHO WE ARE

Dalton is a Health Canada approved, FDA registered, cGMP contract service provider of integrated chemistry, drug development and manufacturing services to the pharmaceutical and biotechnology industries. We accelerate drug development programs by integrating formulation, process development, and manufacturing of API and finished dose forms at a single location. Our client benefits by having fully optimized and scalable processes with reduced timelines and costs throughout all phases of development and manufacturing.

Dalton provides cGMP manufacturing of solid dosage forms and sterile filling services to customers at virtually any stage of development (Phase I, II, III or small scale commercial). We have on-site cGMP fill finish capabilities for both sterile injectable liquids and sterile powders, and a solid oral dosage manufacturing suite for capsule products.

Our ongoing commitment to our clients is reflected in CMO 2018 Leadership Awards in the categories of Expertise, Quality, and Reliability. In 2018 Dalton was re-certified as A Great Place to Work[R] for a fourth consecutive year.

MAJOR MARKETS

Our customers range from the smallest start-up biotechs to global pharmaceutical companies. Dalton offers integrated services supporting R&D through to small scale commercial manufacturing, all in one company. We bring 30 years of experience to our clients' projects with emphasis on quality, speed and flexibility.

SERVICES OFFERED

Dalton offers chemistry, API and finished dose services for research and cGMP requirements. Our chemistry services cover a wide range of molecule and reaction types. Dalton's in house analytical services can characterize your molecule and provide analytical development, validation, release and stability services. Our sterile filling services are scaled perfectly for Orphan Drug Products. Our services include:

* Medicinal Chemistry

* Custom Synthesis and Process Development

* cGMP API (bench top to multi-kg scales)

* Formulation Development

* Analytical Services

* cGMP Sterile liquid, lyophilized and powder dosage forms (vials)

* cGMP Powder filled capsules--solid oral

The Dalton Research Molecules business carries over 2,500 standards, building blocks, metabolites and impurities in its growing catalog available for direct purchase.

Discover, Develop, and Manufacture with Dalton.

WWW.DALTON.COM

DPT

318 McCullough

San Antonio, TX 78215

Tel: 1-866-CALL-DPT

Web: www.dptlabs.com

Company Description

DPT, a Mylan company, is a leading contract development and manufacturing organization specializing in semi-solid and liquid dosage forms. Working in close consultation with clients, our experts streamline development from pre-formulation through commercialization. With an 80-year legacy of excellence, unmatched technical expertise and fully integrated drug development and manufacturing services, DPT delivers proof in every product.

Facilities

Research and Development

Location: San Antonio, Texas

Size: 258,000 sq. ft.

Focus: Pre-formulation and formulation development and analytical development services. Our scientists and technicians provide research and development services and ensure technical transfers are handled by the appropriate manufacturing center. Our research and development facility also stores raw materials and finished goods and facilitates worldwide product distribution.

Semi-solids and Liquids

Location: San Antonio, Texas

Size: 450,000 sq. ft.

Focus: cGMP pilot-, clinical- and commercial-scale manufacturing for prescription and over-the-counter (OTC) products. This campus features a dedicated 60,000-square-foot cGMP aerosol manufacturing facility, a 25,000-square-foot raw material dispensing and distribution center and a 150,000-square-foot compounding, fill and finish area.

Services and Capabilities

DEVELOPMENT

* Pre-formulation and Formulation

* Analytical Development and Validation

* Process Development and Validation

* Stability Studies: ICH and Custom

* Clinical Trial Material Manufacturing

* In Vitro Release Testing Expertise

* Regulatory Submission Support

* Quality-by-Design

DOSAGE FORMS

* Aerosols

* Creams

* Emulsions

* Extrusions

* Gels

* Lotions

* Ointments

* Solutions

* Suspensions

Emergent BioSolutions, Inc.

400 Professional Drive, Suite 400

Gaithersburg, MD 20879

Tel: 800-441-4225

Fax: 484-843-4414

E-mail: CM0@ebsi.com

Web: www.ebsi.com/CMO

VITAL STATISTICS

Year Founded: 1998

Number of Employees: 1300

Key Personnel: Daniel Abdun-Nabi, CEO; Sean Kirk, SVP, CMO Business Unit Lead; Patrick DePalma, Sr. Director, CMO Business Development

WHO WE ARE

Emergent is a global life sciences company dedicated to one simple mission--to protect and enhance life. We develop, manufacture, and deliver a portfolio of specialty products for civilian and military populations that address accidental, intentional, and naturally emerging public health threats, such as medical countermeasures for biological and chemical threats, as well as emerging infectious diseases. Emergent is also a recognized leader in providing integrated contract development and manufacturing services for both drug substances and sterile injectable drug products. Through our work, we envision protecting and enhancing 50 million lives with our products by the year 2025.

MAJOR MARKETS

Emergent's Contract Development and Manufacturing capabilities support bulk drug substances and sterile injectable drug products from Phase I development through commercial scale production. Incorporating research, full product/process development, and nonclinical/clinical staffing, our highly-experienced team is responsible for discovering, developing, and/or commercializing innovative therapeutic products and technologies that protect and enhance life. Our state-of-the-art, single-use facility (located in Baltimore, MD) currently produces over 30 commercial products approved for distribution in over 50 countries and we support a wide range of clinical stage programs (Phase 1-3). Since 1998, our facilities have supported over 200 clinical drug product candidates, making Emergent a proven partner for pharmaceutical or biotechnology companies looking for value and reliability through outsourcing.

For 20 years, Emergent has been dedicated to the quality of services and safety of our products for our customers in effort to create a healthier world.

SERVICES OFFERED

Drug Substance Manufacture

* Clinical & Commercial Scale

* Single-Use Platform (up to 4000L)

* Cell Culture

* Viral

* Mammalian

* Avian

* Insect

* Process Development

* Upstream & Downstream

Drug Product Manufacture

* Small Molecules & Biologies

* Viral Fill/Finish Capabilities

* Clinical & Commercial Scale

* Vials & Syringes

* 2cc-100cc (2 vial filling lines)

* 0.5cc-50cc (1 syringe filling lines)

* Aseptic Processing

* Terminal Sterilization

* Lyophilization

* Lyo Cycle Development

* Material Characterization

* Microbiology

* ICH Stability

WWW.EBSI.COM/CMO

EMINENT

SERVICES CORPORATION

7495 New Technology Way

Frederick, MD 21703-9401

Tel: 240-629-1972 * Fax: 240-629-3298

E-mail: info@emiserv.com

Web: www.emiserv.com

VITAL STATISTICS

Year Founded: 1997

Key Personnel: Krupakar P.Thadikonda, PhD, President & CEO; Arun R. Kantareddy,VP (Operations); Anbu S. Devasahayam,VP (Administration); Vijaya Rangavajhula,VP (QA/QC)

WHO WE ARE

EMINENT Services Corporation with pride, positions itself to be the pre-EMINENT provider of cost effective, regulatory compliance, professional technology, and value added Investigational Drug Management, Biological Specimen Logistics & Information Technology Services to our customers by reducing the time involved in drug product development cycle.

SERVICES OFFERED

EMINENT is committed to provide quality contract services to pharmaceutical and biotechnology industry, academic & healthcare institutes and Federal & State Clinical programs with complete regulatory compliance in the areas: Regulatory Affairs; Pre-formulation and Formulation Studies; Study Product Development; Clinical Supplies Manufacturing; Analytical Method Development and Validation; Stability Evaluation; Packaging and Labeling; Investigational Drug Repository; Direct to Patient Pharmacy; Global Distribution; and Cold Chain Logistics.

Biological Specimen Repository is designed for cataloging, archiving, and tracking pre-clinical and clinical biological specimens using our custom designed inventory management system based upon bar coding system.

EMINENT website offers Client Login to monitor the regular, return and retention inventory by protocol, track shipment orders, biological specimen inventory and generate various custom reports.

FACILITIES

EMINENT owns and operates its facilities in a 57,000 square foot free standing brick building in Frederick Maryland. The facilities are monitored for critical environment controls, physical security and video surveillance. Our Investigational Drug Repository offers various storage conditions including ICH stability storage conditions and secure DEA vault. The Biological repository offers ultra-low freezers and Liquid Nitrogen storage conditions.

EMINENT features N+l redundant backup generator, and redundant cooling systems for all walk-in refrigerators and freezers to reduce the risk of failure. All equipment used in the analytical laboratory, manufacturing, packaging and storage are qualified and calibrated periodically.

AUDITS, PERMITS AND LICENSES

EMINENT has been audited by several Regulatory Agencies, including FDA, DEA, EPA, ENVISA, EMEA and PMDA and operates with following licenses and permits:

* FDA Registered Drug Establishment

* DEA Licenses CI-CV (Rx, Manufacturer, Research, Distributor & Exporter)

* EPA Regulated Waste

* MD State Board of Pharmacy (Rx & Distributor)

* MD State Controlled Dangerous Substances CI-CV (Rx, Research, Manufacturer & Distributor)

* MD State Special Medical Waste

* Centers for Disease Control and Prevention

WWW.EMISERV.COM

Eurofins BioPharma Product Testing

Tel: 1-717-656-2300

E-mail: pha@eurofinsUS.com

Website: www.EurofinsUS.com/BPT

VITAL STATISTICS

Year Founded: 1961

Number of Employees: > 6,000

Number of Facilities: 34

Key Personnel: Tim Oostdyk, Ph.D., Chairman, Eurofins Lancaster Laboratories, Group Senior Vice President, Eurofins BioPharma Product Testing

WHO WE ARE

Eurofins BioPharma Product Testing offers complete CMC Testing Services for the Bio/Pharmaceutical industry, including all starting materials, process intermediates, drug substances, drug product, packaging, and manufacturing support through our broad technical expertise in Biochemistry, Molecular & Cell Biology, Virology, Chemistry and Microbiology.

Our fundamental philosophy is to help clients efficiently allocate their research and manufacturing expenditures by strategically engaging them to meet their unique outsourcing needs.

We offer the ability to manage your testing programs more efficiently through your choice of three unique service models, including our award-winning Professional Scientific Services[R] (PSS), Full Time Equivalent (FTE) or traditional fee-for-service. You can choose the best, most cost-effective service solution for your project goals.

MAJOR MARKETS

With a global capacity of more than 1,600,000 square feet of facilities and 34 locations worldwide, our network of GMP laboratories and vast experience allow us to support projects of any size from conception to market.

Our local presence with four key sites in the US, including Lancaster, PA; Portage, MI; Columbia, MO; and San Diego, CA, ensures personal service backed by a unique global breadth of harmonized capabilities that supports all functional areas of bio/ pharmaceutical drug development.

SERVICES OFFERED

* Method Establishment (Development, Feasibility, Optimization, Verification, Qualification, Validation, Transfer)

* Release Testing

* Stability Testing & Storage

* Characterization

* Residuals & Impurities Testing

* Raw Materials Testing

* Extractables & Leachables Testing

* Container, Package & Closure Integrity Testing

* Shipping Studies

* Viral Clearance & Viral Safety Testing

* Bioassay & Potency Testing

* Cell Banking Services

* Critical Reagents/Reference Standards Management

* Disinfectant Efficacy/Cleaning Validation Studies

* Environmental Monitoring

* Facility and Process Validation

* Organism Identification

* Clinical Trial Material Support

* Formulation Development/Testing

* Custom Synthesis & Radiolabeling

* Specialized Materials Testing, Functional Testing & Failure Analysis

* Scientific Consulting

Service Models

* Professional Scientific Services[R] (Insourcing Solutions)

* Full Time Equivalent (FTE)

* Fee-For-Service

WWW.EUROFINSUS.COM/BPT

Eurofins Lancaster Laboratories

Professional Scientific Services[R]

2425 New Holland Pike

Lancaster, PA 17601

Tel: 717-656-2300

E-mail: pha@EurofinsUS.com

Web: www.EurofinsLancasterLabs.com/PSS

VITAL STATISTICS

Year Founded: 2002

Number of Employees: > 1,600

Number of Facilities: >70 PSS locations worldwide

Key Personnel and Job Titles: Beth DiPaolo, M.A., SPHR, PSS President and Global Head

WHO WE ARE

Eurofins Lancaster Laboratories Professional Scientific Services[R] (PSS) is a global, award-winning insourcing solution that places our people at your site dedicated to running and managing your laboratory services while eliminating headcount, co-employment and project-management worries.

We infuse our 55-year track record of scientific and laboratory operations expertise, as well as FIR and great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services at your site, using your quality systems and equipment. Our teams will even help you set up your laboratory and validate equipment according to your SOPs and Lean laboratory practices as needed.

Eurofins Lancaster Laboratories PSS employs and manages fulltime employees and provides a comprehensive benefits package, as well as training, development and career advancement opportunities. Offering these additional benefits allows us to attract, retain and motivate high-caliber employees to serve you. Our on-site dedicated leaders manage our full-time employees and provide you with scientific insourced services free from co-employment. PSS is not staff augmentation, so it solves the challenges associated with the EU Temporary Agency's Workers Directive 2008/104.

MAJOR MARKETS

With more than 1,600 employees worldwide, Eurofins Lancaster Laboratories PSS provides services at more than 70 sites in over 15 countries throughout North America and Europe and is part of Eurofins BioPharma Product Testing, which operates 34 laboratory locations, totaling more than 1,600,000 ft2 across 17 countries worldwide.

SERVICES OFFERED

Our PSS Insourcing Solution[R] provides services for clients who require lab services at their facility. We have proven success providing dedicated teams for a variety of technical disciplines that span the drug development pipeline, including:

* Analytical Chemistry

* Microbiology

* Environmental Monitoring

* Proteomics

* Biochemistry

* Quality Assurance

* Sampling

* Stability

* Biopharmaceuticals

* Process Development

* Biomedical Engineering

* Method Development/ Method Validation

* Microscopy

* Bioinformatics

* Genomics

* Cell & Molecular Biology

* Immunochemistry

* Sample Management

* Medical Device Testing

* Engineering

* Project Management

* Bioassay Characterization

WWW.EUROFINSLANCASTERLABS.COM/PSS

Exelead

6925 Guion Road

Indianapolis, IN 46268, USA

Tel: 317-347-2800

E-mail: info@Exeleadbiopharma.com

Web: www.exeleadbiopharma.com

VITAL STATISTICS

Year Founded: Exelead was incorporated in 2017, previously known as Sigma-Tau PharmaSource/Enzon Manufacturing/ The Liposome Company

Number of Employees: 140

Number of Facilities: 1--Manufacturing facility is located in Indianapolis, IN

WHO WE ARE

Exelead is a CDMO dedicated to the development and commercialization of therapeutics to treat life-threatening diseases. Exelead's core technologies focus on the manufacture of sterile drug products specializing in liposomal and PEGylation formulation technologies. Exelead has development capabilities that can be utilized to improve drug delivery and drug product characterization. The Indianapolis, Indiana manufacturing facility produces proprietary parenteral pharmaceuticals for oncology and enzyme replacement treatment, as well as for the treatment of numerous infectious diseases.

Our staff is a balance of: chemists, chemical engineers, microbiologists, and pharmaceutical manufacturing experts. Senior Exelead management is a mix of seasoned executives from the pharmaceutical and biotechnology industries. Exelead is a wholly owned subsidiary of Essetefin SpA (Rome, Italy) and is led by John Rigg,Vice President and General Manager.

MAJOR MARKETS

Exelead manufactures drug products that are distributed globally and offers solutions at every phase of the drug development process (Pre-Clinical, Phase I/II/III, and Commercial). At Exelead, our mission centers not just on what we do, but whom we serve. Exelead offers rare dedication to the customer who needs a partner--not just a CMO/CDMO.

SERVICES OFFERED

End-To-End Solution

* Method Development & Transfer

* Process Development

* Technical Transfer

* Clinical Manufacturing

* Process Scale Up

* Commercial Manufacturing

* Project Management and CMC Support

Flexible Production

* Liposomal Formulation

* PEGylation

* Aseptic Fill

* Automated Inspection

* Packaging

* Quality Control

* Sterility Assurance

* Quality Assurance

* Supply Chain

WWW.EXELEADBIOPHARMA.COM

Exova SL Pharma

1300 First State Boulevard, Suite C

Wilmington, DE 19804

Tel: 302-636-0202

International: 1-866-263-9268

E-mail: americas@exova.com

Web: www.exova.com

WHO WE ARE

Since 1997 Exova SL Pharma, previously called SL Pharma Labs, has provided high value and high quality contract services for parenteral, ophthalmic and topical drug product development and clinical manufacture. Exova SL Pharma's mission is to support clients in meeting their CMC product development, clinical manufacturing of innovative drug products, scale-up of generic drug products, technology transfer and regulatory approval toward meeting their commercialization timelines and regulatory requirements. Our facility is FDA registered and cGMP compliant and has maintained a clean record with the FDA since the establishment of the company in 1997.

What differentiates Exova SL Pharma from other contract research and development organizations?

>> experienced scientists and leadership from industry that understand the challenges of drug product development, regulatory submission, and commercialization processes in today's highly regulated market

>> adaptive and customized approach to the unique needs of every client, drug product and project

>> reliable partner that is committed to meeting client budget and timing requirements

>> collaborative project design and completion from start to finish >> track record of consistent high quality and GMP-Compliance

Exova SL Pharma has a team of experienced pharmaceutical and biotechnology industry leaders with deep knowledge and commitment to outstanding service. The company's strategy is to maintain small, agile project teams that collaborate with clients to assure that all projects are completed efficiently and meet all project scope requirements. You will have one-on-one access to project leaders and the scientist working on your project.

Exova SL Pharma has excellent partnerships and collaborations with several CMOs for commercial manufacture. Based on pre-established and very successful project management systems, we work very closely with the selected CMO's in transferring the required technology in a seamless fashion and provide them technical support through all phases of commercial manufacture including scale-up and manufacture of validation and commercial batches.

MARKETS SERVED

Exova SL Pharma, located in Delaware, is experienced in working with both large and small molecule focused clients that range from large, multi-national through virtual start-up organizations, located within US and overseas. The commonality across the client base from innovator drug companies through generic organizations is a desire for efficient collaborative support that is done on time and on budget every time.

SERVICES OFFERED

Exova SL Pharma is a fully GMP-Compliant organization. The facility houses ICH stability chambers, clean rooms Class 100,000 to Class 100 for sterile and topical product development/clinical manufacturing, QA storage, QC release and stability testing of marketed products and a wide variety of state-of-the-art equipment and instrumentation to handle a wide range of simple to highly complex projects

Exova SL Pharma can handle cytotoxic compounds and Controlled Substances Schedules II through V. The facility is FDA registered and cGMP compliant and has maintained a clean record with the FDA since the establishment of the company in 1997. We commonly test to USP, NF, EP, BP, JP as well as provide other customized method.

* Small and Large Molecules

* Pre-Formulation and Formulation Development

* Analytical Method Development Testing

* Microbiological Development and Testing

--Sterility/ Endotoxin/ Bioburden/particulate matter

--Antibiotics and Antimicrobials

--Filter Validation Studies

* ICH Compliant Stability Testing For API And Drug Product

* Tech Transfers

* CMC Consulting and Regulatory Documentation Preparation

* Drug/excipient/packaging compatibility

* Early stage stability studies for active drug substances and product formulations

* Media Fills

* Microbiological development and QC testing

* Stability indicating assay development, method validation, and forced degradation studies

Federal Equipment Company

8200 Bessemer Avenue

Cleveland, OH 44127

Tel: +1 800 652 2466

E-mail: adam@fedequip.com

Web: www.fedequip.com

VITAL STATISTICS

Year Founded: 1957

Headquarters: Cleveland, Ohio, USA

Key Contacts--Pharmaceutical:

Adam Covitt, Vice President

Matt Hicks, Chief Operating Officer

Justin Kadis, Business Development

WHO WE ARE

Federal Equipment Company is a reliable resource for pharmaceutical processing and packaging equipment, with over 60 years of expertise buying and selling used equipment. We take away the headaches when you need to sell equipment, offering deep knowledge of equipment values and accurate appraisals. We optimize the value you recoup, and expertly remove equipment, protecting your facility. When you need equipment, we have a broad, on-hand inventory of reliable equipment from leading OEMs. Our experience ensures you buy exactly the right equipment for your need, with fast turnaround, and we offer expert training and troubleshooting from an industry expert.

MAJOR MARKETS

Federal Equipment Company holds equipment inventory serving the manufacture and packaging of pharmaceuticals, vitamins, nutraceuticals, supplements, ingredients, and food & beverage products. We have equipment for solid dose (tablets, capsules, powders), semi-solids (creams, ointments, gels, foams), liquid fill & finish, transdermal patches, and more.

SERVICES OFFERED

Federal Equipment Company helps leading companies with all of their equipment needs, including procurement of required machines and disposal of surplus equipment. Our consulting services help organizations manage surplus equipment through efficient asset management, optimizing the return. Our strength is the deep knowledge within our extensive sales, maintenance, rigging and appraisal staff. We purchase single units, complete product lines and entire facility inventories. This enables us to offer a large, on-hand inventory of processing and packaging equipment to meet the needs of companies seeking to buy equipment. We professionally install, troubleshoot and will train operators on specific equipment you have.

WWW.FEDEQUIP.COM

Contract Manufacturing

Fresenius Kabi Contract Manufacturing

Tel: + 49 6172 686 1240

E-mail: cmo@fresenius-kabi.com

Web: https://cmo.fresenius-kabi.com

VITAL STATISTICS

More than 20 Facilities Worldwide

Number of Employees: 36,000

Turnover: [euro] 6.0 billion (2017)

WHO WE ARE

Fresenius Kabi Contract Manufacturing leads the way in contract development and manufacture of sterile pharmaceuticals and medical devices. As Fresenius Kabi's business-to-business platform we are dedicated to contract manufacturing and offer our partners easy access to our worldwide development and manufacturing capabilities.

MAJOR MARKETS

Fresenius Kabi Contract Manufacturing works with pharmaceutical and medical device companies all around the globe. With over 40 years of experience in contract manufacturing, we have developed active partnerships with an impressive number of top-tier pharmaceutical multinationals as well as start-ups and biotech companies.

SERVICES OFFERED

Fresenius Kabi Contract Manufacturing opens the door to over 20 Fresenius Kabi manufacturing facilities and innovation centers worldwide. Our facilities are run in strict compliance with international quality standards (cGMP, WHO-GMP, ISO-Norms).

Our Approach:

Fresenius Kabi Contract Manufacturing provides its customers with seamless support throughout the entire life-cycle of their sterile products. We are there from the early stages of development right through to the commercial manufacturing.

Manufacturing Technologies:

* Aseptic processing, terminal sterilization

* Processing of solutions and disperse systems such as emulsions and liposomes

* Handling of high-active APIs

* Lyophilization

* State-of-the-art packaging and labeling

Container Technologies:

* IV-bags, 40-5,000 ml, single- and multi-chamber

* Bottles, 50-1,000 ml, glass and plastic

* Vials, 1-100 ml, glass and plastic

* Ampoules, 1-20 ml, glass and plastic

* Pre-filled syringes, 1-50 ml, glass and plastic

* Customized containers

Support Services:

* Full analytical, technical and regulatory support

* Process development

* Development of drug delivery systems and medical devices

* cGMP compliant manufacture of clinical batches

* Worldwide logistical support

HTTPS://CMO.FRESENIUS-KABI.COM

FRONTAGE

YOUR DRUG DEVELOPMENT PARTNER

Headquarters, Bioanalytical and DMPK services

700 Pennsylvania Drive

Exton, PA 19341

Phone: 610-232-0100

Fax: 610-232-0101

CMC Services and GMP

Manufacturing

75 East Uwchlan Avenue

Suite 100

Exton, PA 19341

Phone: 484-362-0424

VITAL STATISTICS

Year Founded: 2001

Number of Employees: ~600

Number of Facilities: 6

WHO WE ARE

Frontage Laboratories, Inc. Your Drug Development Partner

Frontage is a CRO providing integrated, scientifically-driven research, analytical and development services throughout the drug discovery and development process to enable biopharmaceutical companies to achieve their drug development goals.

We offer our clients comprehensive services in analytical testing and formulation development, drug metabolism and pharmacokinetics (DMPK), bioanalysis, preclinical safety and toxicology and early phase clinical studies. We have enabled many innovator, generic and consumer health companies of all sizes to file IND, NDA, ANDA, BLA and 505(b)(2) submissions in global markets allowing for successful development of important therapies and products for patients.

We successfully assist clients to advance hundreds of molecules through development to commercial launch in global markets. We are committed to providing rigorous scientific expertise to ensure the highest quality and compliance.

Chemistry, Manufacturing, and Control (CMC) Services

With an outstanding compliance history, the CMC team at Frontage operates under strict adherence to ICH and US FDA GMP guidelines.

Our broad portfolio of services spans drug product development, analysis, and clinical trial materials' delivery and supply, from preclinical stages through Phase II clinical trials. We support a range of delivery systems including oral solids, topical, and sterile.

We have extensive experiences in formulation development, analytical method development and validation, technical transfer, and clinical trial materials (CTM) manufacturing, as well as commercial product release and stability testing for US, EU, and Asian markets.

* Analytical Services for Small Molecule and Biologies

* Product Stability Storage and Testing

* Pre-Formulation and Formulation Development

* GLP Batch Production and Testing for Preclinical Study

* GMP Batch Production and Testing for Clinical Study

* Strong Quality & Compliance Track Record

WWW.FRONTAGELAB.COM

Fujifilm Diosynth Biotechnologies

101 J Morris Commons Lane

Morrisville, NC 27560

Tel: 919-337-4477

+44 (0) 1642 363511

E-mail: contactfdb@fujifilm.com

Web: www.fujifilmdiosynth.com

VITAL STATISTICS

Key Personnel:

Steve Bagshaw, Chief Executive Officer

Martin Meeson, President & COO, RTP, NC & College Station, TX

Paul Found, COO, Billingham, UK

Gerry Farrell, COO, College Station, TX

WHO WE ARE

FUJIFILM Diosynth Biotechnologies is a world leading cGMP Contract Development and Manufacturing Organization (CDMO) supporting our partners in the development and production of their therapeutic biologic, vaccine and advanced therapies. Our network expands within three development and manufacturing facilities located in Billingham, United Kingdom; Research Triangle Park, North Carolina, USA; and College Station, Texas, USA.

MAJOR MARKETS

We serve biopharmaceutical clients of all sizes, worldwide, including virtual, big and small biotechnology companies and large pharmaceutical companies from around the globe.

SERVICES OFFERED

FUJIFILM Diosynth Biotechnologies brings its expertise in Process and Analytical Development and cGMP manufacturing to their partner's therapeutic candidate development at every stage of the product lifecycle, from early protein/viral product expression, process design and cGMP manufacture, through late phase/commercial production, and post approval product lifecycle management.

Capabilities include:

* Global Process Development for early and late phase programs ranging from studies, characterization and validation

* cGMP Manufacturing of biologies with capabilities to support microbial fermentation, and cell culture production for clinical and commercial supply

* Full lifecycle biological and gene therapy manufacturing from initial concept to commercial product

* Fill Finish capabilities for gene therapy products

WWW.FUJIFILMDIOSYNTH.COM

GlobePharma, Inc.

2 B & C Janine Place

New Brunswick, NJ 08901

Tel: 732-296-9700

Fax: 732-296-9898

E-mail: sales@globepharma.com

Web: www.globepharma.com

VITAL STATISTICS

Year Founded: 1993

Number of Employees: 18

WHO WE ARE

GlobePharma, Inc. has been innovating the industry standard for over 20 years. Founded in 1993, GlobePharma introduced the Model I Unit-Dose Powder Sampler. As applications changed, new designs and modifications transformed the sampling line to include more than 25 variations and models from bulk and unit-dose powder, to liquid and semi-solid samplers. GlobePharma offers a line of Cleaning Validation tools and coupons. GlobePharma, Inc. now also offers blenders from formulation to pilot scale, R&D tablet presses, tablet press instrumentation, mills, granulators, and valves. The GlobePharma pipeline is full of new products added in 2015-16 including the new GP Mill 1, GP Mill 5 and the PowderEx III Accelerated Powder Segregation Tester. GlobePharma, Inc. is a global organization serving the pharmaceutical, food, nutraceutical, automotive and cosmetic industries with solid dosage form equipment from lab to pilot scale.

MAJOR MARKETS

GlobePharma, Inc. is a worldwide company serving the following markets:

* Pharmaceutical

* Cosmetic

* Automotive

* Nutraceutical

* Food

* Aerospace

SERVICES OFFERED

GlobePharma offers the following equipment:

* Unit-dose and bulk powder, liquid & semi-solid samplers

* Cleaning Validation Coupons

* Remote Swabbing & Microbiological Sampling Tools

* MiniBlend[TM] Small Batch blender

* MaxiBlend[R] Lab & Pilot Scale Blenders with interchangeable V-Shells, Bins, & Double-cones from 0.5 qt. to 10 cu. ft. with optional intensifier bars

* SimpleBlend[TM]: stand-alone blenders from 1 cu. ft. to 10 cu. ft. with optional intensifier bars

* SIFT-N-BLEND[TM] attachment for single-step sifting & blending

* cGMP Sanitary Butterfly Valves

* PowderEx III Accelerated Powder Segregation Tester

* Tablet Presses, VersPress and MTCM-I, Manual Tablet Compaction Machine

* Tablet Press Instrumentation

* High Shear Granulators

* Cone Mill

* GP Mill-Hammermills

WWW.GLOBEPHARMA.COM

Grand River Aseptic Manufacturing

140 Front Avenue SW, Suite #3

Grand Rapids, Ml 49504

Tel: 616-678-2400

Fax: 616-776-5584

E-mail: info@grandriverasepticmfg.com

Web: grandriverasepticmfg.com

VITAL STATISTICS

Year Founded: 2010

Number of Employees: 150+

Key Personnel: Tom Ross, President and CEO; Nick Bykerk,Vice President of Business Development and Finance; Steve Nole, Vice President of Operations; John Wichelt, Vice President of Client Pharmaceutical Services; Colleen Herczak, Vice President of Quality

WHO WE ARE

Grand River Aseptic Manufacturing was founded in 2010 as a joint venture between the Van Andel Institute and Grand Valley State University. Our company supports the life sciences industry's growing need for high-quality, outsourced sterile parenteral manufacturing.

We are privately held, with more than 100 employees in two locations near downtown Grand Rapids, Michigan. With nearly 40,000 square feet of sophisticated cGMP space, GRAM meets a full range of fill/finish needs, from early clinical fills through commercialization. All our equipment and processes are fully qualified and validated to ensure cGMP compliance.

MAJOR MARKETS

Grand River Aseptic Manufacturing serves the global pharmaceutical and biopharmaceutical industries.

SERVICES OFFERED

* Sterile product development and manufacture

* Aseptic filling and lyophilization of 2mL to 50mL vials

* Pre-filled syringe filling

* Terminal sterilization

* Analytical and microbiological services

* Formulation development

* Test method development and validation

* Process development and validation

* Labeling and packaging

* DEA Controlled Substances (CSIII-V)

* Onsite warehouse and material storage

* Regulatory support

* Biologies manufacturing

FACILITIES

* 11,400 sq. ft. cGMP FDA-inspected manufacturing facility

* 28,000 sq. ft. finishing space (inspection, labeling, packaging, storage)

* ISO 4.8/5 Grade A aseptic filling suite

* ISO 7/Grade C prep area

* ISO 7/Grade C formulation suite

* BMT autoclave and BetaStar autoclave

* Water for injection (WFI) system

* Bausch and Strobel filling machine (KSF1025)

* BOC Edwards lyophilizer (32 sq. ft.)

* PennTech vial washer (RW-500)

* Lytzen depyrogenation oven

* Colanar Syringe Filler (FSV1054)

* Opening in 2020: 60,000+ sq. ft. fill/finish facility

WWW.GRANDRIVERASEPTICMFG.COM

Grifols International, S.A.

Parc empresarial Can Sant Joan

Av. de la Generalitat, 152-158

08174 Sant Cugat del Valles Barcelona--SPAIN

PARENTERAL CDMO

Grifols vital statistics

Year founded: 1940

Number of Employees: Over 18,300

Annual Worldwide Revenues: 4,3 Billion [euro]

Grifols is one of the world's leading pharmaceutical companies with 30 subsidiaries, and operations in more than 100 countries.

Services offered

Our high level of specialization allows us to offer pharmaceutical development and manufacturing for products that require advanced technology and complex production processes, such as sterile solutions and lipid emulsions. Medical devices that require meticulous design and assembly are also offered and customized. Grifols Partnership has two FDA and GMP approved manufacturing facilities in Spain for intravenous solutions that have parametric release certification.

Our approach

Grifols Partnership works together with the customer from the early stages of development until commercial manufacturing.

* Pre-formulation and development

* Scale-up and technology transfer of methods

* Validation batches

* Process scale-up and pilot production including 10/300L reactors

* ICH stability studies

* Analytical development and validation

* Clinical batches

* Dossier support documentation

* Commercial manufacturing of industrial batches

* Labeling and packaging

* Serialization

Who we are

Grifols Partnership is a business-to-business contract development and manufacturing platform for sterile solutions and lipid emulsions with a long-term experience in producing intravenous solutions for the pharmaceutical industry worldwide.

Major markets

Over the years we have established successful relationships with customers in global markets, including North America, Canada, Australia and Europe in the following areas:

* Human & Veterinary fields

* New product development

* Generic drug development and manufacturing
TECHNOLOGICAL
CAPABILITIES BY SITE

FACILITIES (SPAIN)

CAPABILITIES                     Parets del    Las Torres de
                                   Valles        Cotillas
                                 (Barcelona)     (Murcia)

Drug Product Development           [check]

Small Molecule Drug Products       [check]        [check]

Terminal Sterilization             [check]        [check]

Light and [O.sub.2] sensitive      [check]

Emulsion Technology                [check]

Vials (5 to 50 mL)                 [check]

Diluents                           [check]

Glass Bottles (50 to 500 mL)       [check]

Flexible bContainers               [check]        [check]
(PP bags, 50 to 1000 mL)

FFS technology for PP bags         [check]        [check]

Regulatory                       FDA, AEMPS, ANMAT, European
                                 Regulatory Authorities
                                 (Infarmed, BfArM, MHRA ...)

Contact us at: partnership@grifols.com | Phone: +34 935 712 199
Visit us at: www.partnership.grifols.com


HERMES ARZNEIMITTEL GMBH

Division HERMES PHARMA

Georg-Kalb-Strasse 5-8

82049 Pullach, Germany

Tel: +49 89 79102-261

Fax: +49 89 79102-159

Web: www.hermes-pharma.com

VITAL STATISTICS

Year Founded: 1907

Number of Employees: 820 worldwide

WHO WE ARE

HERMES PHARMA is the expert in developing and manufacturing user-friendly oral dosage forms--including effervescent and chewable tablets, instant drinks, lozenges, and orally disintegrating granules.

Our user-friendly dosage forms provide an added value to patients and consumers and improve compliance as they

* are easy to ingest, even if their API content is high and they are large in size.

* are convenient to take along--to work, school, etc.

* taste well--even if the API is bitter.

* are easy to swallow--even for people with swallowing difficulties.

* can be taken with or without liquids to suit individual preference.

* offer a variety of choice in terms of flavor.

For over 40 years, HERMES PHARMA has been working with pharmaceutical and healthcare companies around the globe to expand their product lines and grow their brands.

HERMES PHARMA is a division of Hermes Arzneimittel, a leading German provider of high-quality medicines, food and dietary supplements marketed under its proprietary, well-established brands.

HERMES PHARMA offers expert advice and customized solutions at every point along the pharmaceutical value chain, including:

* New product development

* Formulation and analytical development

* Stability testing

* Registration procedures

* Manufacturing of laboratory, pilot and large scale batches

* Quality control and batch release

* Packaging and delivery

* Regulatory support and lifecycle management

From co-developing new products, to out-licensing and contract manufacturing, HERMES PHARMA has different models to support its customers on their way to market success.

WWW.HERMES-PHARMA.COM

Hovione LLC

40 Lake Drive

East Windsor, NJ 08520 USA

Tel: +1 609 918 2600

Fax: +1 609 918 2615

E-mail: hello@hovione.com

www.hovione.com

VITAL STATISTICS

Year Founded: 1959

Number of Employees: 1600

Key Personnel: Guy Villax, CEO and Member of the Board; Frederic Kahn, VP Sales and Marketing; Marco Gil, Senior Director Commercial Services; Roger Viney, Senior Director Products; Filipe Tomas, General Manager, Hovione New Jersey

WHO WE ARE

With 60 years of experience as a CDMO we are a fully integrated supplier offering from drug substance to drug product intermediate to drug product. Our motto "In it for life" means that we are committed to each other and to helping our clients in bringing medicines to market that improve people's lives.

With four FDA inspected sites in Portugal, the U.S., Ireland and China, we work in close partnership with our clients to deliver to the highest quality standards in the most regulated markets in the world. Utilizing the most innovative technologies and methodologies we offer a flexibility that allows the company to serve both the global markets and also to respond to customer's specific demands whenever necessary, allowing to bring better medicines to market faster and therefore to be truly" In it for life".

MAJOR MARKETS

We serve in all the major regulated markets, mainly USA, Europe and Japan, dedicating ourselves to helping Pharmaceutical Customers bring new and off-patent drugs to market. We do well what is difficult, to give our customers what they cannot find elsewhere.

SERVICES OFFERED

Partnering with our clients towards the privilege of serving clients, we offer customized services and innovative solutions from drug substance to drug product with high standards of quality and technical expertise. We provide branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs including highly potent compounds, niche generic API products, and offer proprietary product development and licensing opportunities for drug products. In the inhalation area, we are the only independent company offering a complete range of services.

As leaders in Commercial Spray Drying, we combine the largest capacity, the best scale-up science and the most experienced team to handle projects from development to market. Our particle engineering technologies can address challenges in solubility enhancement, lung delivery, modified release and taste-masking applications and can also handle highly potent compounds.

WWW.HOVIONE.COM

IKA[R] Works, Inc.

2635 Northchase Pkwy SE

Wilmington, NC 28405 USA

Tel: 910-452-7059; Toll Free: 800-733-3037

Fax: 910-452-7693

E-mail: process@ikausa.com

Web: www.ikausa.com

VITAL STATISTICS

Year Founded: 1910

Number of Employees: Over 800 with 8 locations worldwide

WHO WE ARE

Internationally renowned in process, laboratory and analytical technology, IKA[R] is the global market leader and driving force behind innovation in many product fields. Founded in 1910 the family-owned company can now look back on more than a century of company history. In the late 1940s IKA also pioneered the first rotor/stator high shear mixing technology. The process division now produces a vast array of high shear mixers and--with over 65 years of experience--has attained a leading position for mixing, milling and dispersing solutions as well as complete engineered systems. This presence has been established and strengthened by the innovative technology of IKA.

Our high quality mixing, homogenizing, wet milling, dry milling, kneading, and turnkey equipment is widely used in the cosmetic as well as personal care industries. IKA offers first-rate quality from initial consultation to full scale production.

SERVICES OFFERED

From the initial planning stages to final product realization, IKA technology and services is with you each step of the way by offering a multitude of services:

* Designing complete production systems

* Modern R&D facility equipped for proof of concept testing

* Performing test runs when developing new products to optimize machine choice

* Trial equipment fleet consisting of over 80 stand-alone machines available for on-site trials

* Planning and implementation of mechanical, electrical and pneumatic installations

* Commissioning, including a processing test and training of the operating personnel

* Qualification support

* Technical advice for questions concerning operation, process, and maintenance of IKA machines and plants

* In-house & on-site maintenance repair service technicians

* Spare parts service

BEYOND BOUNDARIES[TM]

ILC Dover

One Moonwalker Road

Frederica, DE 19946 USA

Tel: 302-335-3911 or 800-631-9567

Fax: 302-335-1320

E-mail: customer_service@ilcdover.com

Web: www.ilcdover.com

VITAL STATISTICS

Year Founded: 1947

Number of Employees: Approximately 600

Key Personnel: Fran DiNuzzo, President & CEO Brad Walters, General Manager Ken Elston, CFO

Curtis Gingles, VP Pharm/BioPharm & Division Manager Ian Sklar, Director of Quality & Regulatory Affairs

WHO WE ARE

ILC Dover is a world leader in the innovative design and production of engineered products employing high-performance flexible materials. Since 1947, ILC has provided engineered solutions to complex customer problems. Known for the production of space suits for NASA, we leverage our vast materials, engineering, process, and design experience to create high performance systems for a wide range of industries. We provide: Bulk Packaging/ Processing Systems to food, chemical, and personal care markets, Powder Containment/Processing Systems to pharmaceutical and biopharmaceutical markets, Respiratory Protection Equipment/ Environmental Safety Solutions to industrial, pharmaceutical, and healthcare markets, Rapidly Deployable Flood Protection Systems to commercial and municipal markets, Advanced Space Suits/Space Inflatables to space market Airships, Aerostats/ Unmanned Aerial Vehicles to aerospace market Our international engineering and production facilities coupled with a network of global representatives support customer needs around the world.

MAJOR MARKETS

ILC Dover supports Pharmaceutical and Biopharmaceutical customers with disposable systems engineered to contain powder transfers from large scale manufacturing to nanogram levels. With over 300,000 successful installations worldwide since 1997, we support cost effective manufacturing every day with applications ranging from single use transfers to multi-use flexible enclosures. Our standard and custom engineered solutions have been proven to improve profitability by reducing capital and cleaning costs, reduce the time to get your end product to market and reliably support operations from research and development through manufacturing.

SERVICES OFFERED

DoverPac[R] Containment Systems, an ILC Dover brand, is the global pioneer of disposable process and powder containment systems. Launched from a partnership with multi-national pharmaceutical companies to develop high containment for API production and oral sold dosage processing, DoverPac[R] is the global standard for containment, reliability, and service. Benefits of Flexible Containment include: Ease of retrofit, reduced capital costs, improved ergonomics. Services include: bioprocessing, disposable/single-use, and sterile filling.

WWW.ILCDOVER.COM

Integral BioSystems, LLC

23 Crosby Drive, Suite 100A

Bedford, MA 01730

Tel: 781-275-8059

E-mail: dkarasic@integralbiosystems.com

Web: www.integralbiosystems.com

VITAL STATISTICS

Year Founded: 2009

Number of Employees: 14

Approximate Annual Revenues: $2m-$5m

Key Personnel: Shikha P. Barman, Ph.D. Chief Executive Officer and Chief Technology Officer

Dave Karasic, Esq. Chief Operating Officer and Legal Counsel

WHO WE ARE

Integral BioSystems is a drug delivery CRO that offers an integrated, practical approach to formulation development projects for both small molecule and biologic actives. The company's expertise is focused on sustained release microsphere/ nanosphere development, liposomes, nano/microsuspensions and lyophilized products for IM, SQ, ocular, otic, dermal and urologie applications.

The company's business approach is based on providing quality, top-notch formulation development services to start-ups, virtual, small companies to assist taking concepts from the bench-top to technology transfer to GMP facilities. Additionally, the company has solidified relationships with large generic companies both in the U.S. and internationally, to develop complex-to-formulate product pipelines.

MAJOR MARKETS

Integral BioSystems is experienced working with all types of drug development entities in the US and around the world. Whether the client organization is a virtual business with no lab facilities of its own headed by a sole proprietor, an established pharmaceutical company with extensive development facilities and staff, or anything in between, Integral BioSystems can help to minimize development time to speed your drug to market.

SERVICES OFFERED

Integral provides "soup-to-nuts" assistance in complex drug delivery projects, especially in product development of sustained release microspheres/nanospheres, depots, liposomes and cyclodextrin-based products. For all products, Integral adheres to QbD principles, required by the FDA for pharmaceutical products. Integral has developed relationships with GMP product manufacturers to tech-transfer its processes.

In addition to complete pharmaceutical formulation development project planning and execution, Integral BioSystems offers individual, rapid testing that includes NMR, UV-Vis, FTIR, microscopy, DSC-TGA, particle sizing, Log P, pH, SEM, XRPD, osmolality, Karl Fisher, volatiles by GC, and dose verification and viscometry. Additionally, Integral performs deformulation of generics, permeability testing, dissolution studies, and stability testing of prototypes.

WWW.INTEGRALBIOSYSTEMS.COM

Global Headquarters

JRS PHARMA GmbH & Co. KG

Holzmuhle 1

D-73494 Rosenberg, Germany

Phone: +49 79 67152-312

Fax: +49 79 67 152-345

Customer Service: +49 79 67 152-345

USA & Canada

JRS PHARMA LP, USA

2981 Route 22

Patterson, NY 12563-2359

Phone: 845-878-8300

Fax: 845-878-3484

Customer Service: 1-800-431-2457

Web: www.jrspharma.com/pharma_en/contact-us/

VITAL STATISTICS

Year Founded: 1878

Number of Employees: 2000+

Number of Facilities: 7 Manufacturing Sites Across Three Continents

WHO WE ARE

JRS PHARMA is a leading manufacturer of excipients, offering a complete portfolio of solutions for the global health science industry. Stability, reliability, security--that's our promise. We embrace the needs of our customers across all segments of the health science industry worldwide. Our innovative excipients and coatings, along with our formulation expertise, provide our customers with a complete portfolio of solutions for the development and manufacture of solid and liquid dosage forms.

MAJOR MARKETS

JRS Pharma is a first class manufacturer of excipients, offering pharmaceutical and nutraceutical companies a wide range of innovative excipient products that enable scale-up, improve content uniformity and optimize formulations.

SERVICES OFFERED

Our excipients portfolio includes: high functionality excipients, binders, disintegrants, lubricants, functional fillers, thickeners, stabilizers, carriers, and coatings. In addition to our wide range of excipients, we offer excellent technical support to address the needs and formulation challenges of our customers.

WWW.JRSPHARMA.COM

Jubilant HollisterStier Contract Manufacturing & Services

Main Office: 3525 N. Regal Street

Spokane, WA 99207-5788

Tel: 509-489-5656

Fax: 509-484-4320

E-mail: info@jublHS.com

Web: jublHS.com

VITAL STATISTICS

Year Founded: 1921

Number of Employees: 800+

Key Personnel: Spokane, WA; Montreal, Quebec

WHO WE ARE

Jubilant HollisterStier is an integrated contract manufacturer of sterile injectables, ophthalmics, otics and sterile and non-sterile topicals and liquids. Our facilities in North America provide specialized manufacturing services for the pharmaceutical and biopharmaceutical industries. We provide a full range of support and services to streamline the manufacturing process such as on-site assistance from process qualifications through product release.

FACILITIES

Sterile Injectable Fill/Finish--Spokane & Montreal

Sterile liquid fill/finish into vials and ampoules, clinical to commercial, lyophilization

Sterile Ophthalmics & Otics--Montreal

Solutions & suspensions, ointments, computerized batching, CIP/SIP system, plastic and laminate tubes

Non-Sterile Topicals & Liquids--Montreal

Gels, liquids, ointments and solutions filled into bottles, tubes, and pumps. Gravity fed filling, oxygen, heat and light sensitive products

SERVICES OFFERED

Fill/Finishing

* Process Development

* Compounding and Aseptic Compounding

* Filling

* Lyophilization

* Terminal Sterilization

* Inspection

* Labeling

* Packaging

* Multiple Storage Conditions

* Vendor Qualification

Analytical and Microbiological

* Method Validation

* Qualification of Analytica Methods

* Technical Transfer of Methods

* Sterility Testing

* Biological Assays

* Stability Storage and Testing (ICH Standards)

* Finished Product and Raw Materials Testing

* High Performance & Ultra High Liquid Performance Chromatography (HPLC & ULPC)

Validation

* Process Validation

* Project Master Plans

* Protocol Writing and Reports

* Installation Qualification

* Operational Qualification

* Performance Qualification

* Project Management Summary

* Component Evaluation

Regulatory

* Regulatory Strategy Formulation

* Effective Facilitation of Interaction with Regulatory Authorities

* Guidance and Expert Review of Regulatory Submissions

* Prepare and Supply a Complete Range of Regulatory Documents

* Drug Master File

* Electronic Submissions (eCTD)

* FDA (CDER, CBER), EMA, PMDA, ANVISA, Health Canada

WWW.JUBLHS.COM

Legacy Pharmaceutical Packaging

13333 Lakefront Drive

Earth City, MO 63045

Tel: 314-813-1555

E-mail: sales@legacypackaging.com

Web: www.legacypackaging.com

VITAL STATISTICS

Year Founded: 2004

Number of Employees: 375

Key Personnel: Brad Rayner, VP of Sales & Marketing Nathan Bender, Associate Director, Sales & Marketing

WHO WE ARE

Legacy Pharmaceutical Packaging is a privately held contract packaging company located in St. Louis, Missouri. Operating out of a combined 300,000 sq. ft. cGMP compliant facilities, Legacy is a full-service pharma solution provider servicing the branded, generic, government, wholesale and major retail markets. Legacy is built for rapid response and specializes in high speed bottle filling, blistering, compliance and unit-of-use packaging and offers a wide range of secondary packaging and kitting solutions. Legacy is registered with the FDA, VAWD accredited and licensed by the DEA to handle Schedule II-V drug product.

MAJOR MARKETS

Headquartered in St. Louis, Missouri, Legacy's facilities are centrally located to offer our customers an ideal location for meeting their packaging, warehousing, and distribution needs. Legacy services customers nationwide, providing packaging services direct for Manufacturers, Retail Pharmacy Chains, major Wholesalers.

SERVICES OFFERED

Legacy's commitment to being your Total Pharma Solution Provider ensures we offer a wide range of packaging services including: bottle and blister filling, compliance packaging, retail and community pharmacy unit-of-use solutions, flexible secondary packaging, inspection and rework. Legacy is equipped and ready to handle your inline or secondary serialization needs to help bring your product to market.

WWW.LEGACYPACKAGING.COM

Lonza

Pharma & Biotech

Lonza

Munchensteinerstrasse 38

Basel 4002, Switzerland

Tel: +41613168111

E-mail: pharma@lonza.com

Web: www.lonza.com

VITAL STATISTICS

Year Founded: 1887

Number of Employees: 14,600

Approximate Annual Revenue: $5.1 Billion

Number of Facilities: 18

WHO WE ARE

Lonza Pharma & Biotech provides global contract development and manufacturing services that enable pharma and biotech companies to bring medical innovations to patients in need. We are recognized for our reliability and high-quality, our global capacity, our innovative technology platforms, and our extensive experience. We have helped to commercialize pioneering therapies and we continuously invest and innovate to meet your expectations also for future medicines. Our belief is that the best outcome--for you and for your patients--comes as a result of a successful collaboration. Together, we can solve the next challenge and bring your next medicine to life.

MAJOR MARKETS

We serve pharmaceutical and biopharmaceutical companies globally, striving to help reduce capital risk and increase chances of business success. Our customers range in size from small, virtual companies to some of the world's largest drug manufacturers. We have contract development and manufacturing services located around the globe: Switzerland, USA, United Kingdom, Singapore, China, Spain, the Netherlands, Germany, Belgium, Mexico, India, Indonesia, and Japan. In addition, we have local sales offices in additional countries to enable a close communication with you.

SERVICES OFFERED

We manage projects from pre-clinical development stage through commercialization across mammalian and microbial produced biologies, small molecules, bioconjugates, and cell and gene therapies. Covering both drug substance and drug product, our comprehensive service offering enables a tailor-made, cost-effective and phase-appropriate package that suits your business needs.

In 2018, we expanded Ibex[TM] Solutions with two new, innovative packages--Ibex[TM] Design and Ibex[TM] Develop. The expansion is designed to meet the evolving needs of biotech companies with antibody therapies, from the preclinical stage through to commercialization--now also including cGMP fill and finish of sterile liquid and lyophilized vials within Lonza's network. The packages offer drug substance development and drug substance and drug product manufacturing from gene-to-vial and are intended to accelerate the path to clinic and market. Together with the existing Ibex[TM] Dedicate offering, targeting companies in later stages, the new investment allows Lonza's customers to benefit from a complete product lifecycle management.

WWW.LONZA.COM

LSNE Contract Manufacturing

23 Commerce Drive

Bedford, NH 03110

Tel: 603-668-5763

E-mail: info@lyophilization.com

Web: www.lyophilization.com

VITAL STATISTICS

Year Founded: 1997

Number of Employees: 250

Key Personnel: Christine Palus, VP of Sales & Marketing

Facilities:

LSNE's five fully integrated cGMP facilities span over 100,000 ft2 and can produce drug product and medical devices for preclinical through commercial use.

* 3 Parenteral Drug Product Manufacturing Facilities--2 located in Bedford, NH and 1 located in Madison, WI

* QC Laboratory located in Bedford, NH

* Medical Device Manufacturing Facility in Manchester, NH
                          Commerce   Harvey   Sundlal   Madison
                           Drive      Road

Process Development          *         *         *         *

Aseptic Fil/Finish for       *         *                   *
Clinical Material

Aseptic Fill/Finish for      *         *
Commercial Material

Aseptic Lyophilization       *         *                   *

Aseptic Formulation          *

Medical Device               *
Manufacturing

Non-Aseptic Fill/Finish      *                   *

Bulk Lyophilization          *                   *

FDA Inspected                **        **       **


WHO WE ARE

LSNE is a privately held CDMO with five cGMP facilities; four located in New England and one in Madison, WI. For more than two decades, LSNE has been dedicated to providing comprehensive aseptic fill/finish, lyophilization and development services. LSNE's proven track record of regulatory execution and compliance, along with the technical expertise and infrastructure allows LSNE to be your end-to-end development and manufacturing partner.

SERVICES AND CAPABILITIES

Aseptic Fill Finish Capabilities

* Preclinical through commercial

* Three automated fill lines; filling, stoppering and crimping in ISO 5 environment

* Batch sizes ranging from a couple hundred vials to 35,000 vials

* Vial sizes from 2 cc to 100 cc

* Peristaltic pump technology for low shear stress processing and minimized line loss

* Six aseptic lyophilizers ranging from 36 ft2 to 270 ft2

* Lyophilizers designed to handle organic solvents

* Lyophilizers include redundant compressor and vacuum pump systems to protect high value products

Development Capabilities

* Formulation development, lyophilization cycle development, and accelerated R&D stability

* Extensive experience with proteins, mAbs, peptides, oligonucleotides, and small molecules

* Eight dedicated development lyophilizers

* Developed over 500 lyophilization cycles

* Tech transfer and scale up support available

QC Capabilities

* Full QC laboratory to support in-process, release and stability testing

* ICH stability programs

* Analytical method development

* Photostability

Bulk Lyophilization

* Bulk drug intermediates

* 260 [ft.sup.2] lyophilizer

* Up to 400 L capacity

* Disposable Lyoguard trays or dedicated SS trays

* Harvesting options available

WWW.LYOPHILIZATION.COM

Lyophilization Technology, Inc.

30 Indian Drive

Ivyland, PA 18974-1431

Tel: +1 215-396-8373

Fax: +1 215-396-8375

E-mail: inquiry@lyo-t.com

Web: www.lyotechnology.com

VITAL STATISTICS

Year Founded: 1992

WHO WE ARE

Lyophilization Technology, Inc. (LTI) is a Contract Development & Manufacturing Organization (CDMO) focused on all aspects of lyophilization for preparation of health care products.

Clients leverage on our abilities for bringing new products to the clinic and implementing improvements for current products. Capitalize on over 25 years of excellence and our unparalleled capabilities in product development, process engineering, clinical manufacturing, and technical support.

MAJOR MARKETS

Biotechnology and pharmaceutical organizations spanning virtual companies to large multi-national corporations, along with universities and research institutes have engaged our support in successful collaborations for a variety of projects. These projects span initial product and process development for new entities right out of drug discovery through Phase I/II clinical material, to technology transfer and commercial manufacturing with regulatory approval. Gaining a global reputation, LTI has been sought after and completed projects with clients in the Australia, Austria, Canada, France, Germany, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Puerto Rico, Russia, Singapore, Switzerland, and the United Kingdom, as well as the United States.

SERVICES OFFERED

Capabilities

* Pre-clinical through Phase II Clinical Materials

* Lyophilized/liquid products

* Bulk Lyophilization

* Containment processing

* Dedicated/disposable equipment

* Batch sizes: up to 75L

* Vials: 2 to 160 mL

* Cartridges/syringes: single/dual chamber

* Novel delivery systems

* Nucleation On-Demand Technology

* DEA license

* US/EU compliant

LTI successfully developed formulations, processes or prepared clinical material for many diverse products, such as:

* Biologies (up to BSL-2)

* Oncolytics

* Liposomes

* Anti-Infectives

* Peptides/Polypeptides

* Proteins/mAbs

* Diagnostics

* Nanoparticles/Emulsions

* Vaccines andVLPs

* Controlled Substances

* Highly Potent Compounds

* Antibody Drug Conjugates

* Devices/Delivery Systems

* Small and Large Molecules

Development Sciences

Development Sciences focuses on formulation through finished product characterization. The Process Lab provides capacity for small to medium scale lyophilization. Filtration, filling, stoppering, and loading the qualified pilot-scale lyophilizers are in certified Class A/100 environments, emulating aseptic manufacturing conditions.

* Product Design

* Formulation Development

* Thermal Analysis

* Cycle Design/Refinement

* Product Characterization

* Pilot Plant Scale-up

* Isolation/Containment

* Cartridges

Clinical Manufacturing

US/EU compliant Clinical Manufacturing Area (CMA) for preparation of clinical material is for processing a wide range of products, including those having unique requirements. The CMA includes an aseptic suite featuring advanced containment/isolation technology using unique disposable negative pressure isolators inspected and approved for handling BSL-2, cytotoxic and highly potent compounds.

* Aseptic compounding

* Pre-clinical through Phase II

* Toxicology Material Processing

* Small to medium batch sizes

* Liquid/Diluents

* Cartridges

Technical Services

Technical services are available providing support for all aspects of lyophilization.

* Customized Training

* Consulting on equipment specifications

* Process requirements

* Consulting on CMC submission

* Supporting process validation

* Technology transfer

* Process excursions

* Product and process troubleshooting

* Batch record review

* Compliance auditing

WWW.LYOTECHNOLOGY.COM

MARKEN

a UPS Company

Headquarter Office

1009 Slater Road, Suite 120

Durham, NC 27703

United States

Tel: +1 800 627 5361

E-mail: info@marken.com

VITAL STATISTICS

Year Founded: 1980

Slumber of Employees: 900+

Headquarters: Research Triangle Park Durham, North Carolina, USA

WHO WE ARE

Marken is the clinical supply chain subsidiary of UPS[R] and the global leader in patient-centric supply chain solutions for pharmaceutical and life science industries. Marken is the industry leader in Direct-to-Patient services and biological sample shipments, and offers a state-of-the-art, GMP-compliant depot network and logistic hubs in 49 locations worldwide for clinical trial material storage and distribution. Over 900 personnel manage 50,000 drug and biological sample shipments every month across more than 150 countries and covering all temperature requirements. Additional services include biological kit production; ancillary material sourcing, storage and distribution; shipment lane verification and qualifications; and GDP, regulatory and compliance consultancy.

SERVICES OFFERED

Biological Shipments

* Biological Sample Shipments

* Global Kit Assembly & Shipment

* UPS Drop-off Service (U.S.)

* White Glove Services

* Temperature-Controlled Packaging

Patient Care

* Cell, Gene and Immunotherapy

* Expanded Access Programs

* Direct to/from Patient

* Home Health Care

* Patient Communications Center (PCC)

Global Storage and Distribution

* Depot Network

* Pick and Pack

* Drug Product Shipments

* Medical Devices

* API and Bulk Drug Substance

* Ancillary Supplies

* Labeling and Late Stage Customization

* Consolidated Investigator Site Shipment

* Return and Destruction

Management and Oversight

* Brokerage Services

* Chain of Custody and Identity

* Global Project Management (GCC)

* Qualified Person Services (EU)

* Risk Assessment and Shipping Lane Verification

* Regulatory, Trade Compliance and Customs

WWW.MARKEN.COM

Metrics Contract Services

1240 Sugg Parkway

Greenville, NC 27834

Tel: 252-752-3800

Fax: 252-758-8522

E-mail: thomas.salus@maynepharma.com

Web: www.metricscontractservices.com

VITAL STATISTICS

Year Founded: 1994

Number of Employees: Approximately 200

Contact: Tom Salus, Director of Sales

WHO WE ARE

Metrics Contract Services is a full service pharmaceutical development and manufacturing organization serving clients worldwide. We deliver proven scientific and operational excellence for oral dosage forms. Today, as a subsidiary of Mayne Pharma Group, we offer clients more resources and capabilities than ever before.

SERVICES OFFERED

Pharmaceutical Development and Clinical Trial Materials Manufacturing

We offer comprehensive formulation development services from preclinical through Phase III CTM including: tableting, immediate release, modified release (including controlled/matrix and sustained release), capsule filling, milling, micronizing, enteric coating, spray drying, extrusion, and spheronization. Our facilities and processes are designed to handle potent products, cytotoxic compounds, and controlled substances.

Analytical Services

With more than 110 chemists on staff, Metrics analyzes the physical and chemical characteristics of drug substances and drug products through development and validation of methods, release and stability testing. We perform this work in compliance with industry standards and international regulatory guidelines.

Potent Products

Our potent facilities provide total engineered containment through customized, hardwall isolation technologies. Containment is achieved at 30 nanograms per cubic meter of room air; equipment and change parts are dedicated exclusively to potent use. The facility features independent entry, exit and equipment double airlocks, decontamination showers, dedicated washroom, dedicated equipment storage and pass through for product/waste.

Fast Track First Time In Man (FTIM) Studies

Metrics Contract Services has successfully delivered materials for over 150 FTIM studies. Our process ensures speed and quality, with a 16-24 week timeline from receipt of well characterized NCE to shipment to the clinic. Services include stability studies, analytical methods development and validation. Choose simple formulation, blended powder in capsule, or neat API in a bottle.

Concept to Commercialization

The parent company of Metrics Contract Services, Mayne Pharma, recently invested $80 million to significantly expand facilities and equipment at its site in Greenville, NC. Construction of the new 126,000 sq. ft., oral dose commercial manufacturing facility is now complete. The facility quadruples the company's US manufacturing capacity, and the repurposing of existing space creates 10+ new analytical laboratories and formulation development suites.

The new facility means Metrics Contract Services can offer a more complete "concept to commercialization" solution in one contiguous location for clients, providing larger scale and increased capabilities for seamless scale-up, eliminating the need for site transfers.

WWW.METRICSCONTRACTSERVICES.COM

Molded Fiber Glass Tray Company

6175 US Highway 6

Linesville, PA 16424

Tel: 814-683-4500; Toil-Free: 800-458-6050

E-mail: info@mfgtray.com

Web: www.mfgtray.com

VITAL STATISTICS

Year Founded: 1952

Number of Employees: 150

Key Personnel: Anthony Cicero, Pharmaceutical Product Line Manager; acicero@mfgtray.com

WHO WE ARE

The Molded Fiber Glass Tray Company (MFG Tray Company) was founded in 1952 in Linesville, Pennsylvania, and are pioneers in the material handling industry. We, like other divisions of Molded Fiber Glass Companies, have found great success applying the unique properties of reinforced composites to solve problems in various industries. We manufacture reinforced composite trays, containers, and flats used in the material handling, industrial, confectionery, bakery, food service, pharmaceutical, and electronics markets for in-process handling of goods.

MAJOR MARKETS

MFG Tray is a full-scale global company, that has been offering solutions to the material handling, industrial, confectionery, bakery, food service, pharmaceutical, and electronic industries for over 65 years. Our customers can access our services and purchase our products from anywhere in the world. MFG Tray Company products are currently sold to over 21 counties worldwide and we are looking to grow that number substantially over the next year.

SERVICES OFFERED

MFG Tray manufactures vial trays, gel cap drying trays, storage trays and sterilization trays for the pharmaceutical and biotech industries that are highly functional and economical alternatives to metal or plastic trays and containers. Unlike plastic, MFG Tray composite material handling products are inherently strong and dimensionally stable and will not bend or sag under heavy loads. Unlike metal, they will not dent, corrode or bend. The durability of composites translates into years of dependable performance. The inherent dimensional stability ensures easy integration with automation machinery. The sterilization trays can be used in continuous temperatures ranging from -60[degrees] to 250 degrees F (-51 to 121 degrees C) and are resistant to oils, solvents, greases and mild acids as well as alkaline solutions within a pH rating of 3.0 to 10.0.

WWW.MFGTRAY.COM

Maruho Hatsujyo Innovations (MHI)

55 Accord Park Drive

Norwell, MA 02061

Phone: 617-653-1617

E-mail: sales@mhi-innovations.com

Website: www.mhi-innovations.com

VITAL STATISTICS

Year Founded: 2014

Number of Employees: 46 (US and Japan)

WHO WE ARE

Maruho Hatsujyo Innovations (MHI), the U.S. subsidiary of Maruho Co. Ltd, a major Japanese healthcare company, distributes blister thermoforming equipment built by MHK (Maruho Hatsujyo Kogyo), another Maruho subsidiary. MHK has been building these machines since 1987 and is one of the leading suppliers of healthcare packaging machinery in Japan. Over 400 MHK machines have been installed in Japan and Asia. Its customers include Maruho and leading Japanese and multinational healthcare companies.

MHI's Mission is to meet customer needs by providing:

* The highest possible quality blister packaging equipment

* Unparalleled ease-of-use including simple set-up and run procedures, simple rapid tooling change-overs, and easy to understand manuals

* Technical service, tooling, and integration services locally in

North America

* Exceptional value with economical pricing

FEATURED PRODUCTS & SERVICES

MHI's EAGLE-Uni semi-automatic blister machine is designed for small-scale production, packaging development and material testing, the versatile unit performs forming, sealing and punching operations in consecutive steps at one universal station.

Measuring just over 1.2 meters in length and less than a meter tall, the compact EAGLE-Uni offers a format area of 150x150mm, and forming depths up to 30mm. The machine handles a wide range of forming materials--including PVC, PVDC, ACLAR, PP, PET and ALU--and all typical lidding substrates including ALU, paper, PVC, PET, and laminates. EAGLE-Uni can run up to five cycles per minute, and is suitable for packaging solids, powders, liquids or devices.

Other MHI blister machines include:

* Ideal for producing small-lot orders with multiple products, the low-weight, highly mobile EAGLE-Pro blister machine makes up to 50 blisters/min.

* The EAGLE-Omni, whose platen sealing capabilities make it particularly versatile with a 30mm forming depth.

* MHI's signature EAGLE-Rx is a compact balcony design, servo driven, high performance blister machine capable of producing up to 200 blisters/min at a format area of 90x130mm.

* MHI's highest-output blister machine, EAGLE-Max is suited for medium-to-high batch sizes and offers quick, tool-free changeover. It can produce up to 600 blisters/min at a format area of 150x265mm.

Mikart, LLC

1750 Chattahoochee Avenue

Atlanta, GA 30318

Tel: 404-351-4510

Toll-free: (888) 4MIKART

Fax: 404-350-0432

E-mail: sales@mikart.com

Web: www.mikart.com

VITAL STATISTICS

Year Founded: 1975

Number of Employees: 250

Key Personnel: Michael Kallelis, chief executive officer; Tom Head, vice president operations; Judy Howard, vice president, scientific affairs

WHO WE ARE

A recognized leader in contract pharmaceutical manufacturing, Mikart specializes in the development, manufacturing and packaging of solid dose and liquid products. Our 40,000 sq. ft. Science Center provides state-of-the-art development and analytical services. Manufacturing capabilities include fluid bed granulating, roller compacting and high shear granulating. With more than 234,000 sq. ft. of development and production facilities in Atlanta, Georgia, Mikart offers contract clients more than 43 years of experience, a responsive working relationship and the ability to take products from formulation development through full-scale commercial production. All packaging lines are 2023 compliant for serialization.

MAJOR MARKETS

Mikart provides a wide range of services to the pharmaceutical industry, including PhRMA, specialty pharma and biotech.

Pharmaceutical Manufacturers

SERVICES OFFERED

* Formulation Development

* Analytical Methods Development

* Methods and Process Validation

* Stability Testing

* Clinical Supplies Manufacturing and Packaging

* Immediate and Controlled Release Tablet Manufacturing

* Capsule Manufacturing

* Oral Liquid Manufacturing

* CII--CV Controlled Drug Manufacturing

* Film Coating

* Fluid Bed and High-Shear Granulating

* Solid Dose and Liquid Bottle Packaging

* Bottle Powder Filling

* Blister Packaging/Card Sealing/Cartoning

* Laminated Foil Pouch Packaging

* Liquid Unit Dose

* Low Humidity Manufacturing

* Cold Storage

* Regulatory Services

* Serialization Services (2023 compliant)

WWW.MIKART.COM

Mission[R]

PHARMACAL

CORPORATE OFFICE

10999 IH 10 West, Suite 1000

San Antonio, TX 78230

BOERNE FACILITY

38505 IH 10 West

Boerne, TX 78006

Tel: 210-696-8400

E-mail: CDMOSolutions@MissionPharmacal.com

Web: www.MissionPharmacal.com

VITAL STATISTICS

Year Founded: 1946

Number of Employees: 600+

Key Personnel: Tom Dooley, CFO Eric White, SVP, Regulatory Affairs Mark Celeste, SVP, Contract Manufacturing Operations Jon Taylor, VP, Development Operations

WHO WE ARE

Mission Pharmacal is a privately held pharmaceutical company based in San Antonio, Texas. For over 70 years, the company has been improving the lives of people through every stage of life by developing, manufacturing, and delivering innovative, high-quality prescription, over-the-counter products, and medical devices. Mission offers a full range of contract services for product development, manufacturing, packaging with serialization, and distribution. Mission specializes in transdermals, liquids, creams, ointments, and tablets.

WWW.MISSIONPHARMACAL.COM

SERVICES OFFERED

Our state-of-the-art manufacturing facilities in Texas and Florida have 300,000+ square feet of combined space and offer the following services:

DEVELOPMENT

* Formulation

* Analytical method development and validation

* Scale-up

* Technology transfer

MANUFACTURING

* High-shear and Fluid-bed granulation

* Co-melts

* Particle sizing

* Blending/Mixing

* Tableting

* Tableting film capabilities (Aqueous and organic)

* Transdermal and free film delivery systems (Including our patented Anhydroflex[TM] technology)

PACKAGING

* Bottle filling (Tablets, liquids, and semi-solids)

* Tube filling

* Blister packaging

* Sachets (Tablets and semi-solids)

* Cartoning

* Tray packing

LABORATORY

* Method development

* Method validation

* Method transfer

* Cleaning validation

* ICH stability testing

SERIALIZATION

* DSCSA compliant packaging and labeling

* Unique Device Identification (UDI)

Moravek, Inc.

577 Mercury Lane

Brea, CA 92821 USA

Tel: 714-990-2018

Fax: 714-990-1824

E-mail: info@moravek.com

Web: www.moravek.com

VITAL STATISTICS

Year Founded: 1975

Number of Employees: 35

WHO WE ARE

GMP [[sup.14]C] API synthesis, Quality Control, issuance of Certificate of Analysis, and Quality Assurance release of API for use in human clinical trials observing FDA GMP guidance ICH Q7 Section XIX are some of Moravek's core competencies.

Our highly experienced GMP API radiochemistry, QC and QA teams have successfully completed over 200 GMP [[sup.14]C] API syntheses, and all GMP APIs have met customer and FDA or EMEA acceptance criteria. In recent years, the contribution of our highly experienced Director of Quality Assurance to Moravek's quality systems and procedures and the commissioning of four purpose-built ISO Class 7 cleanrooms have enabled Moravek to become one of the most trusted and responsive providers of GMP [[sup.14]C] APIs for use in human clinical trials.

MAJOR MARKETS

Moravek can deliver worldwide. We service the pharmaceutical industry with high quality radiolabeled compounds for research, pre-clinical trials, and clinical trials. Our expert staff has completed over 200 GMP projects that have all been accepted by regulatory bodies for use in humans. In order to support this growing sector, we are continually upgrading and expanding our facility and staff to exceed customers'expectations.

SERVICES OFFERED

[sup.14]C GMP API, Custom radiolabeling, Analytical services, Purification services, Stable-isotope labeling, Temperature-controlled storage

WWW.MORAVEK.COM

YOU DEMAND. WE DELIVER.

Natoli Engineering Company, Inc.

28 Research Park Circle

St. Charles, MO 63304

Tel: 636-926-8900

Fax: 636-926-8910

E-mail: info@natoli.com

Web: www.natoli.com

VITAL STATISTICS

Year Founded: 1973

Number of Employees: 350+

Key Personnel: Dale Natoli, President

WHO WE ARE

Natoli Engineering Company is the undisputed global leader in tablet compression tooling manufacturing. But we are far more. Founded on the uncompromising principle to manufacture and deliver the highest quality tablet compression products at a fair price with exceptional customer service, Natoli continues to build on 45 years of innovation and industry leadership. Our state-of-the-art manufacturing facilities, award-winning engineering team, and dedicated production staff enable us to offer competitive pricing without compromising our high standards of quality or customer service.

MAJOR MARKETS

Natoli serves the pharmaceutical, nutraceutical, veterinary, confectionery and industrial tableting and encapsulation industries in major markets around the world.

SERVICES OFFERED

Natoli offers a full spectrum of products and services including tablet compression tooling, tooling design, tablet design, tooling evaluation and repair, technical training and the largest selection of tablet compression accessories in the industry. In addition, we provide:

* A diverse line of best-in-class production and R&D tablet presses

* Tablet press refurbishment and instrumentation for most brands of presses

* Premium replacement parts and turrets for nearly all makes and models of tablet presses

* Formulation development and evaluation

* Metallurgical Analysis

* Natoli AIM[TM] Data acquisition and control system software

* Premium encapsulation machine change and spare parts

WWW.NATOLI.COM

pci

PHARMA SERVICES

Corporate Headquarters

3001 Red Lion Road

Philadelphia, PA 19114

Tel: +1 215-613-3600

E-mail: sales@pciservices.com

Web: www.pciservices.com

VITAL STATISTICS

2017--PCI acquired Millmount Healthcare Dublin, IRE/EU

2018--PCI acquired Pharmaceutical Packaging Professionals in Melbourne Australia as well as Sherpa Clinical Packaging in San Diego, CA.

Number of Employees: 3,500 employees across 8 global locations

WHO WE ARE

PCI Pharma Services is an integrated full service provider, a proven and trusted partner to leading companies in the global healthcare industry. We offer unparalleled expertise and experience in taking compounds from the earliest stages of development through to successful commercialization, delivering speed-to-market and commercial success for our customers.

Our core services support each stage of the product lifecycle, including drug development, clinical trial supply, commercial launch and ongoing commercial supply. We partner with clients in providing innovative technologies, flexible solutions, and an integrated supply network supporting lifesaving medicines destined to over 100 countries around the world.

We support clients with a dedication to providing the industry's leading experience, exemplified in our operational flexibility, delivery, commitment to safety, supported by industry leading technologies and an exemplary quality and regulatory record. This has allowed us to be the partner of choice for leading pharmaceutical companies around the world, operating as a seamless extension of their business.

MAJOR MARKETS

PCI provides Drug development, Clinical trial services, as well as Commercial manufacturing and packaging services for brand and generic pharmaceuticals, biotech, device, over-the-counter pharmaceuticals, animal health, and consumer healthcare/beauty. Our state-of-the-art cGMP facilities feature site segregation for Schedule II--V Controlled Substances, Animal Health, Hormonal Products, Penicillin Products, Cytotoxins, and Potent Compounds. We support Cold Chain requirements including controlled ambient / CRT: 15-25[degrees]C, 2-8[degrees]C, -20[degrees]C, -40[degrees]C, -80[degrees]C, and -196[degrees]C for Advanced Therapeutic Medicinal Products (ATMP).

SERVICES OFFERED

Drug Development:

PCI offers full service Formulation Development including Analytical Development/Characterization and Xcelodose[R] product-in-capsule delivery for early phase clinical trials, as well as an extensive array of sterile and nonsterile delivery forms for early phase studies.

Clinical Trial Services:

PCI supports investigational medicines with Tablet, Capsule, Powder and Liquids Manufacturing, Analytical Development, Stability Testing, Clinical Packaging and Labeling including product Blinding and Randomization, Global Storage and Distribution, as well as Returns Management and Destruction.

Commercial Services:

PCI supports commercial product manufacturing including Commercial scale-up and large-scale manufacturing. Investments include separate suites for large volume tablets manufacture plus roller compaction technology for heat and moisture sensitive formulations. We offer Packaging Services for a broad range of delivery forms including Oral Solids, Powders, Liquids, Creams and Gels, as well as Injectable and Parenteral Delivery forms including Device Assembly. In support of commercial supply we offer Analytical Testing and Stability services.

Serialization and Anti-counterfeiting:

PCI is leading the global market in Serialization and Anti-counterfeiting, having invested in leading technologies and providing commercial serialized product for over six years supporting medicines destined to established and emerging markets. PQ recently celebrated installation of its 80th Serialization line.

Potent Compounds:

PCI provides manufacturing and packaging services for clinical and commercial medicines. PCI features a state-of-the-art, purpose-built, contained manufacturing site for potent compounds with OEL's down to 0.01[micro]g/m3. This facility was recognized by ISPE as a Facility of the Year in 2014. Potent compound manufacturing is further supported by segregated, purpose-built packaging facilities in both Europe and North America.

WWW.PCISERVICES.COM

Pfizer CentreOne[TM] Contract Manufacturing

235 E. 42nd Street

New York, NY 10017, USA

The Americas: +1-224-212-2267

Europe, Middle East, Africa: +32-2-714-6507

Asia Pacific: +65-64190240

pfizercentreone@pfizer.com

www.pfizercentreone.com

WHO WE ARE

Pfizer CentreOne is a global CDMO embedded within Pfizer. We focus on custom API synthesis, sterile injectable fill-finish and highly potent oral solid dose; and are a leading supplier of steroid and hormone APIs and intermediates. For more than 40 years, we've manufactured complex compounds for our biopharmaceutical partners, guiding their drugs safely from development through commercialization.

The value of the embedded-CDMO model. Your molecule is manufactured in the same facilities that produce Pfizer's own drugs, with the same vigilance and care. Throughout the development process, you'll work with a dedicated program manager and core team of experts who deeply understand your molecule and business goals. Should challenges arise that require specialized knowledge, labs or technology, they can harness literally a world of Pfizer resources on your behalf, while serving as your advocate across the broader Pfizer organization.

MAJOR MARKETS

Putting Pfizer's global experience to work for you. Pfizer CentreOne has manufacturing facilities in the United States, Europe and Asia Pacific that have been carefully selected to meet your needs. Our practical regulatory and commercial experience spans more than 100 countries around the world. We help you not only launch your compound, but select packaging and lifecycle management strategies that work most successfully in your chosen market(s).

SERVICES OFFERED

Custom API synthesis

* Able to perform almost any kind of chemistry you need, we provide complex organic synthesis; small-molecule fermentation and bioprocessing up to 150,000-liter scale; and continuous process optimization.

Sterile injectable fill-finish

* Our expertise includes complex biologies, controlled substances and lyophilization. Starting as early as Phase II, we specialize in helping our biopharma partners--from small biotechs to global companies--successfully develop, scale up and commercialize their novel drugs.

Highly potent oral solid dose

* We have deep experience handling highly potent or highly active drugs. At our state-of-the-art segregated facilities, we partner with you to scale up and safely manufacture your compound.

Specialty APIs and intermediates

* Known for our steroids and hormones, we also offer select antibiotics. In addition to a Pfizer-quality molecule, you can count on a quick response to regulator inquiries when they arise.

WWW.PFIZERCENTREONE.COM

Pharma Packaging Solutions

341 JD Yarnell Industrial Parkway

Clinton, TN 37716

Tel: 800-533-7744

E-mail: ask@pharmapacksol.com

Web: www.PharmaPackagingSolutions.com

VITAL STATISTICS

Year Founded: 1995

Number of Employees: 200

Key Personnel: Reid Lederer, President; Scott Garverick, Vice President, Business Development

WHO WE ARE

Pharma Packaging Solutions (PPS) is an agile, compliant and innovative contract packager and folding carton producer, serving the pharmaceutical and healthcare markets.

We deliver primary and secondary packaging in the forms of bottle filling, blister packaging, repackaging, wallet cards, physician samples, cold chain packaging, compliance packaging, parenteral packaging and folding cartons.

Our facilities are state-of-the-art and readily scalable to accommodate a wide variety of regulatory requirements.

Our site is a temperature and humidity controlled environment and we maintain video surveillance of our packaging suites and facilities.

Meeting MHRA, FDA, DEA regulations and other international standards. GDUFA Compliant and Serialization Ready. Meeting special requirements such as Rest-of-World (RoW) packaging, Cold Chain and Retain Storage, Bright Stock Labeling.

Watch a short video to find out more about what we can do for you: www.pharmapackagingsolutions.com/about-us/media/

MAJOR MARKETS

Pharma Packaging Solutions serves markets such as: pharmaceuticals (Rx, OTC, generic, specialty pharma), personal care, nutritionals, medical device and veterinary care. We also serve private label and contract manufacturers, as well as retail pharmacies.

SERVICES OFFERED

* Offering blister packaging, bottling, folding carton production, kitting, vial/ampule and parenteral labeling as well as repackaging. Medical device and kit packaging available.

* Low RH primary packaging suite--3% RH at 70 degrees Fahrenheit. Expanded DEA vault & cold storage. Can Package Solid Dose Schedule ILV

* New serialization and aggregation equipment on our primary and secondary packaging lines

* Compliant with the DEA, FDA and MHRA

* Rest of World (RoW) packaging, Brite stock labeling and F=1 compliance packaging

* GDUFA Compliant

* Offering packaging design services--structural and graphic --for turn-key production on wallet blister cards & folding cartons

* Run size flexibility

* Facilities located within a day's drive of 75% of the US population and most major 3PL's and distribution centers

Pharmasol Corporation

One Norfolk Ave.

South Easton, MA 02375

Tel: 508-238-8542

Fax: 508-238-0105

E-mail: Hkatzen@pharmasol.com

Web: www.Pharmasol.com

VITAL STATISTICS

Year Founded: 1973

Number of Employees: 125

Key Personnel: Marc Badia, President; Howard Katzen, Vice President Business Development; Luis Ferandiz, Vice President Technical Services; James Hammer, Director of Research & Development

WHO WE ARE

Pharmasol is an integrated Contract Development and Manufacturing Organization (CDMO) offering a complete range of services. Pharmasol has an unmatched combination of knowledge, experience, and capabilities in the highly-specialized field of pharmaceutical development and manufacturing of aerosols. We offer full service production of aerosols, foams, liquids, gels, ointments, and lotions for the Rx, OTC and Medical Device categories. We will take you through every step of the process from formulation and clinical supplies to the best delivery choices. Our highly trained and experienced staff will meet your expectations on any size project.

MAJOR MARKETS

Rx Pharmaceutical

OTC

Cosmetic

Medical Device

Personal Care

SERVICES OFFERED

* Formulation development of NDA, ANDA, OTC, Medical Devices, and Cosmetic Products

* Analytical and method development

* Pilot batches

* Clinical trial materials

* ICH Stability testing and storage

* Process development and validation

* Turnkey material sourcing

* Filling and packaging capabilities of aerosols (hydrocarbon, HFA, and Bag-on-valve), liquids, gels, lotions, sprays, and foams

* cGMP commercial manufacturing

* Large and small-scale batching

* Micro testing

* Analytical and Physical testing

* Broad packaging capabilities including labeling, unit cartons, shrink banding

* Scale-up services

* Project management

WWW.PHARMASOL.COM

Pharmaceutics International, Inc. (Pii)

10819 Gilroy Road

Hunt Valley, MD 21031

Tel: 410-584-0001

E-mail: bd@pharm-int.com

Web: www.pharm-int.com

VITAL STATISTICS

Year Founded: 1994

Number of Employees: 375

Key Personnel: Syed E. Abidi, Ph.D., Chairman and CEO Michael Bogda, President and COO

Business Development Team: Hank Nowak, Vice President Global Business Development; David Fidler, Vice President Business Development Operations; Tammy Bryan, Sr. Director of Business Development; Greg Gonzales, Sr. Director Business Development; Tom Ingallinera, Vice President BD Technical Support; Susan Wiggins, Sr. Director Business Development

WHO WE ARE

Pii is a science-driven contract development and manufacturing organization, providing dosage formulation development and cGMP manufacturing services to the global pharmaceutical industry. Pii develops and manufactures a wide range of dosage forms including sterile injectables, oral tablets & 2-piece capsules, soft gelatin capsules, powders, semi-solids and liquids. We create customized solutions to help our partners achieve their development goals and optimize time-to-market.

Pii's integrated services include preformulation testing, formulation development, CTM manufacturing, commercial manufacturing and packaging, complimented by full analytical, quality, regulatory and project management support.

Having supported over 400 development programs, Pii's highly-skilled scientific team has extensive experience working with drug substances representing a broad range of physiochemical characteristics. For poorly soluble compounds, Pii offers multiple bioavailability enhancements, including solid dispersion, particle size reduction and solubilization technologies. Additionally, Pii's development expertise includes immediate, modified and sustained release formulations for both oral and parenteral drug products. Each formulation is designed around the physiochemical properties of the partners'chemical entity, with a focus on the target product profile.

Pii's readily-accessible facilities in Hunt Valley, MD, include over 360,000 sq. ft. of state-of-the-art development and manufacturing space. Our facilities have been inspected by the FDA, MHRA and EMA, and are compliant with the DEA regulations for schedules I-V.

SERVICES OFFERED

Formulation Development

* Oral (soft gels, tablets, capsules, beads, pellets, liquids dosage forms and controlled release formulations)

* Sterile (solutions, suspensions, lyophilized and extended release)

* Semi-solid (creams, ointments and gels)

* Fluid-bed processing (solvent and aqueous)

* Micro and Nano technologies

Analytical and Microbiological Testing:

* Technical Transfer of Methods

* Development, Qualification and Validation of Analytical Methods

* Raw Materials, In-Process and Finished Product Testing

* Endotoxin Testing

* Sterility Testing

* Stability Storage and Testing (ICH Guidelines)

cGMP Manufacturing

* Development, CTM, Scale-Up and Commercial

* Potent compounds, containment-required and controlled substances

* Clinical and commercial packaging, serialization-ready

* Sterile (lyophilized, vials and syringes)

* Tablets, Capsules, Semi-solids, Powders and Liquids

WWW.PHARM-INT.COM

Piramal Pharma Solutions Inc.

1500 Bull Lea Road, Suite 250

Lexington, KY 40511 USA

Tel: 859-977-8600

E-mail: contactus@piramal.com

Web: www.piramalpharmasolutions.com

VITAL STATISTICS

Year Founded: 1998

Number of Employees: 4500 +

Key Personnel:

Amar Karandikar--Head Business Development--North America David Black--Head of Business Development--Europe Gunjan Singh--Head Business Development--API Generics

WHO WE ARE

Piramal Pharma Solutions is the Contract Development and Manufacturing (CDMO) arm of Piramal Enterprises Ltd. and is one of the only CDMOs providing support throughout the entire pharmaceutical drug product life-cycle. It also provides specialty services of Antibody Drug Conjugation & Clinical Trial Supplies for Pharmaceutical Companies across geographies.

Piramal Pharma Solutions supplies product and services to all major pharmaceutical markets through our globally integrated network of sites across North America, Europe and Asia. This structure enables us to offer a comprehensive range of services across the drug lifecycle--from Drug Discovery Solutions, Manufacturing and Packaging of Phase I--III Clinical Trial Supplies through to Commercial Volumes for API and Formulated solid dosage drug product.

Piramal values the relationships with its customers and has established "Customer Centricity" as the driver behind all its actions. It has shaped the structure of the organization and helps us ensure that we always deliver value.

Piramal's philosophy on intellectual property rights ("IPR") is built on upholding the IP generated by the company and all its associates. The company has set up processes to ensure that it respects the IPR of all its clients, partners and competitors, does not infringe any process or product knowingly and/or unknowingly.

Piramal Pharma Solutions has built a reputation for offering excellent manufacturing capabilities and extremely efficient operating systems that deliver outstanding quality, accredited by USFDA and EU regulatory authorities. Such end to end services & competitive pricing makes Piramal a compelling value proposition to our Global Innovator and Generic Customers.

SERVICES OFFERED

Customers can partner with us in any of the following distinct activities or leverage our bundle of services provided through our global network of assets.

* Drug Discovery Solutions

* API Process Development & Optimization Services

* Pre-formulation and Formulation Development--Oral Solids and Sterile Injectables

* Clinical Manufacturing and Supply Services (Phase I-III)

* Development & Manufacture of High potency APIs

* Supply of RSMs, KSMs, Advanced Intermediates and APIs

* Commercial Manufacturing of Finished Dosage Forms

* Antibody Drug Conjugation

* Analytical Services

WWW.PIRAMALPHARMAS0LUTI0NS.COM

Platinum Press

4251 Empire Road 5 Thornton Road

Fort Worth, TX 76155 Oakland, NJ 07436

Tel: 469-733-1506

Fax: 469-733-1510

E-mail: sales@platinumpress.com

Web: www.PlatinumPress.com

VITAL STATISTICS

Year Founded: 2005

Number of Employees: 200+

WHO WE ARE

Platinum Press is a leading supplier of healthcare packaging solutions for the pharmaceutical, medical device and animal care sectors. From concept and design to production and warehousing, the company offers a full line of printed packaging components, including labels, ECL's, folding cartons, blister packaging, pouching and printed literature such as inserts, outserts and medication guides.

Platinum Press produces printed packaging components for several pharmaceutical industry leaders throughout the country. The company's wide array of healthcare packaging solutions and adherence to the most stringent quality standards have earned it a strong reputation in a highly competitive marketplace.

SERVICES OFFERED

Platinum Press manufactures a comprehensive set of packaging solutions. The company has the knowledge to design and produce printed packaging solutions that meet specific customer needs, achieving this through a variety of digital, flexographic and lithographic technologies, many of which are patented.

Platinum Press has become particularly well known for its innovative combination products such as the 'Combination Label' and 'Combination Carton'; each consolidate two or more printed components into a single unit. The company is also helping its customers move toward unit-level serialization as mandated by the Drug Supply Chain Security Act.

RECENT DEVELOPMENTS

Platinum Press has moved its primary facility into a modern 150,000 sq. ft. plant in Fort Worth, TX. Part of the company's $10 million growth investment, the 50% increase in space broadens capacity and houses new equipment, including a new KBA carton press, two Pradi inspection and quality control systems, two Mark Andy P5 presses and a Mark Andy digital hybrid press. Additional G&K-Vijuk folding units also have been incorporated to bolster printed literature capacity.

When combined with its 50,000 sq. ft. plant in Oakland, NJ--which offers additional capacity, redundancy and convenience to East Coast customers--Platinum Press' total manufacturing capacity now exceeds 200,000 sq. ft. The move reflects an impressive growth trend for Platinum Press, with double-digit annual gains occurring during the last few years.

WWW.PLATINUMPRESS.COM

Prince Sterilization Services, LLC

16 Montesano Rd., Fairfield, NJ 07004, USA

57 Rt. 46E., Pine Brook, NJ 07058, USA

Tel: 888-774-6230

E-mail: info@princesterilization.com

Web: www.princesterilization.com

VITAL STATISTICS

Year Founded: 2015 (as a division of Gibraltar Laboratories, Inc.) 2018 (as an independent entity: Prince Sterilization Services, LLC)

Number of Employees: 20

Key Personnel: Daniel Prince, PhD--CEO

Herbert Prince, PhD--CSO

Derek Prince, PhD(c)--President

WHO WE ARE

Operating under Gibraltar Laboratories since 2015, the sterilization services division successfully spun-off into its own entity named Prince Sterilization Services, LLC in April of 2018. Since its inception, Prince has been a leading provider of clean room ready vials, seals, and stoppers. In addition, Prince has led the way in providing innovative contract moist and dry heat sterilization and depyrogenation services to all health care related industries. Our modern thinking, decades of expertise, and state of the art facilities and equipment allow us to develop sterilization cycles for even the most challenging/heat labile drug products and materials.

MAJOR MARKETS

With our corporate headquarters located in New Jersey, Prince is able to service the entire US market. Prince also does business with companies located in Canada, Europe, and South America. We primarily serve the pharmaceutical, biotech, medical device, and related healthcare industries.

SERVICES OFFERED

Prince provides sterile, endotoxin free, and particulate free glass vials, seals, and stoppers to the pharmaceutical and related industries. The materials are handled in a FDA registered facility by staff trained according to GMP and lean manufacturing procedures. All processing of materials, including inspection, washing, depyrogenation/sterilization, and final packaging, is performed in ISO certified clean rooms. Water for injection (WFI) that meets USP and EN285 standards is used as it feeds our component washers as well as our steam sterilizers. Prince is a leading provider of terminal sterilization via steam or dry heat for a variety of health care products.

WWW.PRINCESTERLIZATION.COM

Reed-Lane, Inc.

359 Newark Pompton Turnpike

Wayne, NJ 07470

Tel: 877-290-1090

Fax: 973-709-1091

Web: www.reedlane.com

VITAL STATISTICS

Year Founded: 1959

Number of Employees: 175

Key Personnel:

Patricia Elvin, President, pelvin@reedlane.com Joe Luke, Vice President Sales, jluke@reedlane.com

WHO WE ARE

Reed-Lane is a pharmaceutical contract packager that has been providing innovative solutions to leading RX, OTC and generic pharmaceutical companies since 1959. Its four main specialties are: blister packaging, bottling, pouching and convenience vial filling. Because it is privately held, Reed-Lane serves the complex, ever-changing needs of its customers with great speed and agility. Quality assurance remains paramount at Reed-Lane, where all staff maintain an exemplary standard of cGMP and FDA compliance.

Reed-Lane is based at a 132,000-square-foot facility in Wayne, NJ, with more than 25 dedicated production suites for pharmaceutical (Rx and OTC) packaging. The space includes rooms for individual air handling and HEPA filtration systems in primary suites, temperature-controlled storage for bulk and finished goods, and strict environment and security monitoring throughout. The facility is FDA and DEA registered and Shuster SPR audited.

SERVICES OFFERED

* Solid dose bottle filling

* Thermoform and cold form blister packaging

* Pouching for solid dose

* Convenience vial filling and carded blistering

* Secondary packaging such as wallet cards, blister cards and cartoning

* Compliance packaging

* Vial labeling, kitting and hand assembly

* Cold chain storage from 2[degrees]-8[degrees]C

* Serialization from unit level to full pallet aggregation of bottles and cartons

* Full turn-key services to include component and material sourcing and laboratory services sourcing

Recent Developments

* Reed-Lane continues to serialize products in its dedicated carton serialization suite, as well as inline on its bottling lines. All equipment is designed to offer serialization from the unit level through three levels of aggregation. Each line features the Optel Group TrackSafe[TM] system, and bottling lines feature new NJM labelers offering serialization capabilities. All of Reed-Lane's serialization lines connect to TraceLink[TM] to manage and transmit serialized data with customers and trading partners.

Reed-Lane recently installed a cold chain storage unit featuring the ability to maintain temperatures of 2[degrees]-8[degrees]C. The 100% redundant refrigeration system is monitored 24/7, equipped with an alarm system, and connected to a backup power generator. Also installed was a dedicated climate-controlled secondary packaging suite, which is optimized for kitting projects requiring cold storage. Reed-Lane can label vials and ampules, kit them into cartons with literature and other components, and provide final pack out.

Renaissance Lakewood, LLC

1200 Paco Way

Lakewood, NJ 08701, USA

Tel: 732-367-9000 ext. 4

E-mail: CDMO@renpharm.com

Web: www.renpharm.com

VITAL STATISTICS

Year Founded: 2012

Number of Employees: 500

Key Personnel: Serge Maltais, President & CEO Eric Kaneps, Sr. Director Sales & Marketing

Renaissance is your partner for nasal development and commercialization. Located in Lakewood NJ, we are within an hour drive of both Philadelphia and New York City. Our state of the art facility offers a full-service nasal spray lab, that can support all spray characterization method development and validation. Renaissance also offers analytical and micro lab services to facilitate development & release testing. With over 18 years of nasal expertise, Renaissance has become a leading CDMO for unit dose, bi-dose, and multidose nasal spray products in both sterile and non-sterile formats. Our other capabilities include development and manufacturing of sterile ointments (topical & ophthalmic), sterile ophthalmic solutions and sterile injectables.

MAJOR MARKETS

Renaissance manufactures product for the USA, Canada, EU and UK.

Renaissance is experienced in working with all kinds of partners ranging from virtual companies through Fortune 500 companies.

SERVICES OFFERED

* Formulation Development through Commercial Manufacturing.

* Full analytical laboratory services--method development through validation

* Full spray characterization lab

* DEA Schedule Drugs I-rv.

* Cold Storage

* Aseptic Manufacturing--ointments, solutions & suspensions

* Regulatory Support

* Stability Studies

WWW.RENPHARM.COM

RJ LEE GROUP DELIVERING SCIENTIFIC RESOLUTION

Our expedited testing services provide 24 hr turnaround time for preliminary results to further support your critical and time-sensitive investigations.

RJ Lee Group is a cGMP compliant, ISO 17025 certified, FDA-registered analytical testing laboratory comprised of scientists who apply an industrial forensics approach to Foreign Particulate Matter (FPM) investigations. Our experts use advanced materials research and quality control principles to investigate, define, isolate, and resolve problems faced within the Pharmaceutical and Biotechnology sector. Whether it's related to foreign particulate matter identification in raw materials, CAPA/OOS investigations for quality control groups, or evaluating the content uniformity in finished products, we work closely with our clients to understand the issues surrounding each unique situation.

Foreign Particulate Matter (FPM) Investigations

For more than 30 years RJ Lee Group scientists have been identifying and characterizing FPM in materials from virtually every industry across the globe. As materials have become more sophisticated progressing from the macro to the nano level, we have defined and incorporated the technologies necessary to isolate and evaluate contaminants on all levels. Ensure cGMP compliance from product through process using state-of-the-art technology, targeted forensic expertise and real-time data analysis.

Accreditations

>> cGMP compliant

>> FDA registered

>> ISO 17025 certified

LEARN MORE TODAY

724.519.9068 Option 4 http://go.rjlg.com/contact-pharma

Services and Capabilities

Our analytical testing services focus on supporting pharmaceutical drug manufacturing and quality control programs. We utilize appropriate analytical instrumentation to address each problem. Our scientific expertise allows us to go beyond the delivery of data and facilitate the development of solutions.

>> USP 788 testing: Particulate Matter in Injections

>> CAPA and OOS Investigations

>> Content Uniformity Investigations

>> Contaminant Identification

>> Source Determination

>> Surface Defect Analysis

>> Root Cause Analysis

>> Glass Delamination

>> Particle Morphology Evaluation

>> Particle Size Analysis

Instrumentation & Techniques

>> Fourier Transform Infrared Spectroscopy (FTIR)

>> Scanning Electron Microscopy (SEM)

>> Energy Dispersive X-Ray Spectroscopy (EDS)

>> Raman Spectroscopy

>> Optical Microscopy

>> Polarized Light Microscopy (PLM)

>> Transmission Electron Microscopy (TEM)

>> X-Ray Photoelectron Spectroscopy (XPS)

>> X-Ray Diffraction (XRD)

>> Gas Chromatography/Mass Spectrometry (GC/MS)

>> ICP-AES and ICP-MS

>> Liquid particle counter--HIAC analysis

>> Particle Size Distribution--Laser Light Scattering

Holopack Verpackungstechnik GmbH

Bahnhofstrasse 18,74429 Sulzbach-Laufen

Germany

Phone: +49 7976 98800

Fax: +49 79761014

E-mail: sales.hp@rommelag.com

Web: www.rommelag.com

VITAL STATISTICS

Year Founded:

Holopack Verpackungstechnik GmbH--1975 Maropack AG-1980

Number of Employees:

Holopack Verpackungstechnik GmbH--750 Maropack AG-70

WHO WE ARE

Rommelag CMO provides you with quick and easy access to BFS technology without having to invest in either the mandatory GMP environment that goes with it or the specialists required to operate and maintain the machines. What we offer is the whole spectrum, including the entire infrastructure itself, over 50 years' experience in bottling using BFS aseptic systems, and the expertise you'd only get from the inventors of bottelpack technology.

We offer secure, economical and individualized solutions for the manufacture of sterile solutions, aseptic filling and packaging of pharmaceutical and cosmetic products. Based on leading innovation and decades of experience, we provide the complete package:

* Container Development

* Process Development

* Validation Service

* Pilot- / Stability- / Clinical Batches

* Contract manufacturing of commercial batches

MAJOR MARKETS

Certified by authorities such as FDA / EMEA according to GMP rules and according to ISO 13485 and ISO 9001, Rommelag CMO is able to serve markets worldwide.

The new manufacturing building Pharma 2020 and the biological facility up to Biosafety Level 2 sets the benchmark for modern BFS -contract-manufacturing. It is the key element for the bottelpack[R] Pharma-Suite concept, that provides dedicated areas for high sophisticated drug products.

Maropack recently introduced the Cool-BFS technology for the production of heat sensitive products such as vaccines, antibodies and peptides.

Maropack AG Industriestrasse Briseck 4, CH--6144 Zell LU Switzerland Phone: +41 41 989 74 00 Fax: +41 41 989 74 01 E-mail: mail.mpz@rommelag.com Web: www.rommelag.com

SERVICES OFFERED

We are able to fill the following applications:

Drugs and Medical devices according to GMP

* Eye, ear and nasal drops

* Homeopathy

* Inhalations

* Infusions and injections

* Rinsing solutions

* Orals

* Cremes, ointments and gels

* Wound care products

* Vaginal applications

* Rectal applications

* Disinfectant solutions

* Diagnostics

* Biologicals

* Vaccines

* Biotechnological products

Non-GMP-Products

* Cosmetics

* Food supplements

Technical Products

* Pheromones

* Machine oil and Motor oil

* Detergents

Rovi Contract Manufacturing

C/ Julian Camarillo 35

28037 Madrid, Spain

Tel: +34 91 375 62 30

E-mail: clopezdehierro@rovi.es

Web: www.rovicm.es

WHO WE ARE

ROVI CM--Contract Manufacturing Services for injectables and solid forms; FDA-approved & GMP-certified manufacturing plants.

Manufacturing / Testing / Packaging

Annual capacity of 250 million prefilled syringes, 50 million vials, 3 billion tablets, 50 million sachets and 500 million hard capsules.

SERVICES OFFERED

Manufacturing Plants

Injectables Plant

Exceptional quality level which has been certified by various agencies such as FDA (USA), ANVISA (Brazil), KFDA (Korea), MHRA (UK), AEMPS (Spain), Gulf Cooperation Countries and several ISO certifications.

Pharmaceutical Forms: Prefilled syringes, vials and suppositories. Currently, the drug products manufactured in this plant are exported to over 50 countries worldwide.

Core Business: Specializes in filling and packaging of SVP (small volume parenteral) in prefilled syringes and vials. We cover all syringe formats available in the market from 0.5 ml up to 20 ml (it is filled from 0.2ml up to 20ml). Vials format from 2ml to 10ml.

Water for injections

* Injectables plant offers sterile, prefilled water for injection (WFI) syringes for reconstitution/dilution of drug products.

* Ready to submit documentation (CTD Module 3 & DMF) are available for Europe and the US (with stability data ICH) to facilitate the registration and speed up your product launch.

You can choose the volume you desire: -0.5ml WFI in 1ml STD syringes; 1ml WFI in 1.25ml syringes; 2ml WFI in 3ml syringes; 5ml WFI in 10ml syringes; 10ml WFI in 10ml syringes; 15ml WFI in 20ml syringes; 20ml WFI in 20ml syringes.

Solid Forms Plant

This plant is one of the biggest FDA-approved plant for solid forms in Europe with 83,000 m2 of land. Exceptional quality level which has been certified by various agencies such as FDA (USA), ANVISA (Brazil), AEMPS (Spain), COFEPRIS (Mexico), NIHS (Japan), Gulf Cooperation Countries, Belarusian, Kenyan.

It exports 75% of its production and serves 50 markets within 25 different languages.

Pharmaceutical Forms: Tablets, coated tablets, capsules

Core Business: Specializes in manufacturing and packaging solid forms.

WWW.ROVICM.ES

Samsung BioLogics

300 Songdo BIO Way, Yeonsu-gu

Incheon 406-840, South Korea

Tel: 82-32-455-3114

Fax: 82-32-455-3825

E-mail: biologics@samsung.com

Web: www.samsungbiologics.com

"Excellence in Quality and Compliance"

WHO WE ARE

Samsung BioLogics is a full service provider of Quality driven cGMP contract manufacturing for the global biopharmaceutical industry. Established in April 2011, Samsung BioLogics has provided innovative and unique services with flexibly designed facilities for cost effective production of monoclonal and recombinant drug substance and drug product. The Company offers integrated services which include cell line generation, process development, analytical services, clinical and commercial bulk cGMP manufacturing and fill finish services. Our commitment to provide the best Quality Assurance and Quality Control ensures compliance with worldwide regulatory standards. Samsung BioLogics is centrally located in the heart of Asia, within 20 minutes of Incheon International Airport.

Samsung BioLogics Value

* Fully integrated end-to-end supplier with drug substance and drug product manufacturing

* High titer and low titer options for drug substance manufacturing

* Facility design for global compliance standards

* World class quality systems

* Focus on operational excellence

* Flexible customer engagement models

* Unmatched workforce dedication & industry experience

* Facility designed for global compliance standards

FACILITIES

Samsung BioLogics facilities are located close to the Seoul/Incheon International Airport in Incheon, South Korea. All plants are designed as multi-product facilities to meet the requirements of the US FDA, EMA, and other global regulatory agencies. A state-of-theart multi-product biologies facilities support mammalian production requirements and contain suites for upstream, downstream, fill & finish, and a warehouse including a significant volume for long-term cold storage capacity. The company holds 362KL total capacity with its three multi-product plants in Incheon.

Plant #1: 30 KL (6X5,000L) + Fill/Finish

Plant #2:152KL (10X15,000L + 2xl,000L) + Fill/Finish

Plant #3:180 KL (12X15,000L)

MAJOR MARKETS

Samsung BioLogics provides cGMP contract development and manufacturing to the global biopharmaceutical industry.

SERVICES OFFERED

Cell line, process, and Analytical Development

* Cell line development

* Formulation development

* Process characterization

* Analytical method development

* Bioassay development

Analytical Testing

* Raw material, in-process and final lot release testing

* Bioassays

* Method qualification and validation

* Product characterization & comparability

* Stability storage and testing

cGMP Drug Substance Manufacturing

* Clinical & Commercial scales--1,000L, 5000L, and 15,000L

* Batch & Fed-batch mammalian cell culture

* Segregated purification suites and viral inactivation procedures

* Global regulatory compliance support

cGMP Drug Product Manufacturing

* Aseptic vial filling, liquid & lyophilization

* Vial size range: 2-50ml

* Fully automated integrated filling, inspection & packaging

* Global regulatory compliance support

WWW.SAMSUNGBIOLOGICS.COM

Servier

50 rue Carnot

Suresnes, 92284, France

Tel: +33 (0)1 55 72 70 00

E-mail: cdmo@servier.com

Web: www.servier-cdmo.com

VITAL STATISTICS

Year Founded: 1954

Number of Employees: 21,400

Headquarters: Suresnes (Paris), France

Sites Offering CDMO Services: Europe

* Bolbec, France

* Gidy, France

* Arklow, Ireland

* Warsaw, Poland

* Moscow, Russia

* Madrid, Spain

* Toledo, Spain

North Africa

* Nouasseur, Morocco

* Cairo, Egypt

South America

* Jacarepagua, Brazil

Asia

* Tianjin, China

WHO WE ARE

Servier is an international pharmaceutical company governed by a non-profit foundation. Founded in 1954 and headquartered in the outskirts of Paris, it employs over 21,000 people across a presence in 148 countries. As an independent non-profit entity, under a mandate set out by its founder, Servier reinvests 25% of its turnover (excluding generic drugs) into research and development, constantly driving innovation in cardiovascular, immune-inflammatory and neuropsychiatrie diseases, oncology and diabetes. Servier offers contract development and manufacturing services from 16 facilities globally, supporting engagement with other innovators and leveraging 60 years of experience that has yielded commercialization of over 50 molecules.

MAJOR MARKETS

Servier has a total of 16 manufacturing sites in Europe, North Africa, South America and Asia, and is currently expanding its footprint in North America. Beyond manufacturing infrastructure, Servier has a presence in 148 countries, comprising extensive regulatory approvals and global distribution network. It has the integrated capability to develop and manufacture drug substance and drug product, from lab to commercial scale.

CDMO SERVICES OFFERED

Servier offers contract development and manufacturing of APIs and OSD drug product, with integrated packaging, regulatory support and global distribution. Innovators seeking an outsourcing partner can tap into Servier's embedded scientific expertise, unprecedented commitment to R&D, and experience scaling up 50+ molecules from the lab through to commercial production. Throughout 60 years, Servier has invested in specialized technologies, developing leadership positions in areas such as chromatography. In 2018, it opened an expanded area at its Bolbec facility dedicated to unique preparative chromatography services titled InnoPreP[TM], including continuous processing using SMB and high containment for potent compounds down to OEB 5.

SGS Life Sciences

75 Passaic Avenue

Fairfield, NJ 07004

Tel: 973-244-2435

Fax: 973-244-1823

E-mail: lss.info@sgs.com

For our other locations please visit www.sgs.com/lifescience

VITAL STATISTICS

Year Founded: 1878

Number of Employees: 1,850 in Life Sciences worldwide; 95,000 in the SGS Group

WHO WE ARE

SGS is a leading contract service organization providing clinical research services, analytical development, biologies characterization, utilities qualification, biosafety and quality control testing. We serve a variety of Life Science companies including pharmaceutical, biopharmaceutical, biotechnology, and medical device manufacturers. SGS provides clinical trial management (Phase I to IV) and services encompassing PK/PD simulation and modeling, data management, pharmacovigilance and regulatory consultancy. We also offer laboratory services detailed in this profile that include analytical chemistry, microbiology, stability studies, method development, and protein analysis. SGS is the world's leading inspection, verification, testing and certification company.

MAJOR MARKETS

SGS operates a global, wholly-owned network of 18 Life Science laboratories with facilities in the US, UK, Canada, Belgium, France, Germany, Italy, Switzerland, China, and India. Our customers include large multinational companies as well as midsize or small local enterprises. The Top 20 pharmaceutical companies trust SGS as a partner for their quality control testing.

SERVICES OFFERED

* Quality control testing of raw materials, APIs, and finished products

* Monograph testing (USP, EP, BP, and JP)

* Analytical method development and validation

* Microbiological testing

* Container testing (extractables and leachables)

* Stability testing according to ICH guidelines or customer specifications

* Utilities qualification (air, gas, water and surface)

* Medical device testing

* Protein/peptide analysis and quantification

* Glycosylation analysis

* Biologies safety testing (endotoxin, virus and mycoplasma)

* Cell-line characterization

* Host-cell impurity testing (residual DNA)

* Virus testing (cell bank and virus seeds characterization)

* Antibody product analysis

* Bioanalysis (mass spectrometry, immuno- and cell-based assays)

* Phase I-IV clinical trials

* Data management and statistics

WWW.SGS.COM/LIFESCIENCE

Sharp

E-mail: info@sharpservices.com

Tel: +1-610-395-5800

www.sharpservices.com

WHO WE ARE

Sharp is a leader in contract packaging and clinical trial services to the pharmaceutical and biotechnology industries. Operating from eight state-of-the-art facilities across the United States and Europe, our employees work together to deliver commercial packaging, clinical services, packaging and label design, IRT and serialization solutions to support the complex packaging needs of our global Pharma clients.

CLINICAL SERVICES

Our Clinical Services team has vast experience in managing local and global clinical trial supply chains. We provide a complete range of clinical services from the pre-clinical stage through to commercialization. Our project management and operational teams work together to make it easier than ever for our clients to access resources, partners and markets on a global scale.

PACKAGE DESIGN SERVICES

Our team of designers in the Sharp Global Design Center know the importance of creating packaging that is not only highly functional, but also aesthetically pleasing. Our knowledge of regulatory and compliance challenges places us as the market leader for structural and graphic packaging design.

CONTRACT PACKAGING CAPABILITIES

Sharp Packaging offers a full range of packaging formats including blister packaging, bottling, vial labelling, assembly and labelling of pre-filled syringes, pens and auto-injectors, as well as package design services. A critical component of our packaging service is our project management expertise that includes packaging design and engineering, pre-production, implementation and serialization services that ensure success from design origination to commercial delivery.

SERIALIZATION CAPABILITIES

Sharp has accumulated a vast amount of experience in overcoming the challenges of serialization. This has allowed us to develop an accelerated and scalable on-boarding program for our clients that leverages years of engineering, design, quality, validation and project management experience. We offer a standardized approach that minimizes complexity and reduces timelines for implementation.

If you need a true partner in contract clinical, manufacturing, packaging and technology services, talk to Sharp.

WWW.SHARPSERVICES.COM

Siegfried AG * Untere Bruhlstrasse 4,4800 Zofingen, Switzerland

Phone: +41 62 746 1111 * Fax: +41 62 746 1202

Web: www.siegfried.ch * E-mail: info@siegfried.ch

VITAL STATISTICS

Year Founded: 1873

Number of Employees: 2300

Annual Worldwide Revenues: ~ 750 Mio CHF

Key Personnel: Wolfgang Wienand, Ph.D., Chief Executive Officer and Head Strategy and Mergers & Acquisitions; Jurgen Roos, Ph.D., Chief Scientific Officer; Reto Suter, Ph.D., Chief Financial Officer; Rene Imwinkelried, Ph.D., Head Technical Operations; Marianne Spane, Head Business Development & Sales; Arnoud Middel, Global Head Human Resources; Peter Kiechle, Ph.D., Compliance Counsel

WHO WE ARE

Expect more with Siegfried as your preferred partner Siegfried provides both drug substance and drug product development together with production capabilities at various facilities worldwide. As a partner of Siegfried, you profit from a broad range of technical capabilities and capacities along the value-chain. Creating and manufacturing formulations is our passion. You can expect from Siegfried relevant expertise & know-how at each step of your project, coupled with a keen enthusiasm.

MAJOR MARKETS

As a leading integrated drug substance and drug product provider, our professionalism is pivotal for your project throughout the entire life cycle. Having such a combination of know-how and experience is unique for a supplier of development and production services.

Drug Substances: Custom development and Contract Manufacturing services for both API and intermediates and, also we offer our own portfolio of API (opiates and other controlled substances) as well as dossiers with independent patented technologies.

Drug Products: Our clients benefit from a broad base of know-how in complex oral drug delivery systems including sterile filling, with in-house development, customer development and manufacturing, as well as a portfolio of finished dosage form products.

SERVICES OFFERED

Chemical synthesis & product formulation under one roof Improving chemical processes and formulations is our passion. For custom synthesis, we offer a variety of special technologies, e.g. CTF, hydrogenation, azide chemistry and phosgenation, high pressure reactions and handling halogens (CI/Br/I). We work closely with customers to develop and optimize innovative chemical processes. Also, we have high containment capabilities with complex bridging technologies such as spray drying, which add more benefit and value to our customers. In addition, proprietary portfolios of drugs are available for licensing and nonexclusive sales that focus on opiate base and addiction treatment.

Siegfried also offers complex oral drug delivery systems with in-house developments for licensing. Projects range from formulation, narcotics, high potency active pharmaceutical ingredients, robust manufacturing processes and application of new technologies. Additionally, we are well experienced in developing second and third generation formulations to support product life-cycle management.

Siegfried has worldwide presence with chemical manufacturing multi-purpose cGMP sites located in Zofingen, Switzerland, Pennsville, New Jersey USA; Nantong, China; Minden Germany, Saint-Vulbas France, and Evionnaz Switzerland; and with also drug product manufacturing sites in Zofingen, Switzerland (Pilot); Malta, Irvine USA and Hameln, Germany. Compliance is a top priority at Siegfried. We adhere to the most rigorous requirements and quality guidelines possible; thus, we continue to maintain an outstanding track record by both regulatory authorities and our customers.

WWW.SIEGFRIED.CH

Thermo Fisher Scientific

4815 Emperor Blvd., Suite 300

Durham, NC 27703 USA

Tel: +1 919-226-3200

E-mail: DoingBusiness@Patheon.com

Web: www.patheon.com

VITAL STATISTICS

Number of Employees: 70,000+ Worldwide

Key Personnel: Marc N. Casper, President and Chief Executive Officer, Thermo Fisher Scientific

Michel Lagarde, President, Pharmaceutical Services, Thermo Fisher Scientific

WHO WE ARE

Thermo Fisher Scientific is the world leader in serving science, with revenues of more than $20 billion and approximately 70,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. Through our Patheon and Fisher Clinical Services brands, we deliver industry leading outsourced pharmaceutical development, clinical trial logistics, and manufacturing services.

Together, our Patheon and Fisher Clinical Services brands provide industry-leading solutions for drug development, clinical trial logistics and commercial manufacturing to biopharma clients of all sizes.

Our end-to-end integrated solutions combine the Companys scientific and regulatory expertise with a global facility network of 42 development and manufacturing sites. From very early development, through clinical trials, late phase scale-up to full commercial launch, our experts provide the expertise and technology to accelerate client success at every stage of their drug development journey.

Transforming the Industry

We are transforming the pharmaceutical supply chain model with innovative, flexible and customized end-to-end pharmaceutical development, clinical trial, and manufacturing solutions that reduce complexity, increase quality, and shorten time to market, enabling biopharmaceutical companies to focus on their core competencies.

With Thermo Fisher Scientific, clients gain access to the broadest range of drug substance, pharmaceutical development, clinical trial and drug product solutions for large and small molecules, including more than 75% of oral solid, sterile, and softgel dosage forms. Specialized capabilities include highly potent and controlled substances, solubility enhancement, sterile, modified release, and softgel technologies.

Facilities

With nearly 12,000 pharma services employees, including more than 2,600 scientists globally, we have developed more than 1,000+ molecules in the last decade.

MAJOR MARKETS

Thermo Fisher Scientific, is a leading provider of outsourced pharmaceutical services including API, biologies, early & late phase development, clinical trial solutions, logistics services and commercial manufacturing manufacturing.

SERVICES OFFERED

Our comprehensive range of small- or large-molecule capabilities include:

* Small-Molecule API Development and Manufacture

* cGMP Production

* Process Development

* Generic API and Pharmaceutical Intermediates Portfolio

* Biologies Drug Substance Development and Manufacture

* Mammalian cGMP and non-cGMP Manufacturing

* Process Development

* Drug Substance Characterization

* Analytical Development & Validation

* Formulation Development

* Clinical Trial Material Manufacturing

* Clinical Trial Primary and Secondary Packaging

* Clinical Trial Logistics

* Process & Method Development

* Release & Stability Testing

* Regulatory Support

* Lifecycle Management Services

* Commercial Manufacturing and Packaging

* Tech Transfer/Scale-Up Management

* Risk Mitigation Services

WWW.PATHEON.COM

Unicep

R&D, Mix, Manufacturing

1702 Industrial Drive, Sandpoint, ID 83864

Corporate HQ, Sales & Marketing, Program Management,

Shipping & Receiving, Human Resources, & Manufacturing

4122 S. Grove Road, Spokane, WA 99224

Tel: 800-354-9396 * Fax: 208-265-9696

E-mail: info@unicep.com

Web: www.unicep.com

WHO WE ARE

Unicep develops single-use, high quality packaging for a variety of consumer and professional products. We started in the oral care market in 1991 and have since developed specialty dispensers for companies in a variety of markets. We deliver innovative packaging and superior service to all our customers. We are more than a traditional contract manufacturer--we specialize in manufacturing your unique product and complement it with our innovative single-use packaging components.

MAJOR MARKETS

Unicep is a trusted partner in the manufacturing and packaging of liquid or cream consumer health products, including over the counter (OTC) medicines. Using our advanced liquid filling technology, we offer ready-to-use, single-dose containers which provide mess-free dispensing for products. We have experience with manufacturing products such as analgesics, digestive health, feminine products, first aid, foot care, nutritional supplements, skin health and more.

In a highly competitive marketplace, the success of a new product depends as much on the right delivery system as on the formulation itself. Unicep specializes in providing innovative packaging solutions to meet the most rigorous demands of consumer healthcare products. With the most consumer-preferred formats and our manufacturing expertise, we can help your brands grow with unique tailored solutions.

SERVICES OFFERED

Contract Manufacturing

* Custom mixing capabilities

* Pre-production runs & scale-up capabilities

Contract Filling & Packaging

* Filling for single-use and multi-use packaging

* Packaging options include single-use pouches/sachets, applicators, tubes, syringes, and plastic dispensers

* We also welcome the opportunity to tackle unique packaging ideas and problems to solve

Package Design

* Custom created blow-fill-seal single-use dispensers

* Design, prototype, and production engineering services

WWW.UNICEP.COM

Velesco Pharma

28036 Oakland Oaks Court

Wixom, Ml 48393

Tel: 734-545-0696

E-mail: info@velescopharma.com

Web: www.velescopharma.com

VITAL STATISTICS

Year Founded: 2007

Key Personnel: David Barnes, Chief Executive Officer, Chief Scientific Officer; Gerry Cox, Chief Operating Officer

WHO WE ARE

Velesco applies nimblocity to your early and later stage drug development projects, with our proven formulation of expertise, flexibility, dedication, and velocity to clinic.

Velesco is a CMC contract research organization, founded and staffed by pharmaceutical scientists from Pfizer's former Michigan R&D campus. Our team has experience with more than 400 drug development programs.

Our nimble processes and focused expertise enables us to overcome even the most challenging obstacles. Our team is responsive, accommodating, and eager to help you reach the full potential of your compound, quickly and efficiently.

As experts in pharmaceutical analytical chemistry, drug formulation development, and cGMP clinical supply manufacture, Velesco scientists have a proven track record of moving compounds through the drug development process with nimblocity and unrivaled success.

SERVICES OFFERED

Technical Services

Analytical Method Development/Validation

* Stability-indicating methods

* Drug substance and drug product

* Complex dosage forms

* Potency/Assay/Impurities

* Forced degradation

* Content Uniformity

* Dissolution

* Cytotoxic and high potency

* Routine testing (HPLC, UVMS, viscosity, etc)

* Method troubleshooting

* Method optimization

* Tech transfer

* Experienced with lipids, carbohydrates, and peptides

cGMP Clinical Supplies

* Topical products

* Hand filled soft gel capsules

* Powder in capsule/bottle

* Oral liquids

* Simple blends

* Over-encapsulation

* Cytotoxic and high potency

Formulations

* Clinical and non-clinical

* Topical products

* Injectables

* Ophthalmic

* Hard and soft gel capsules

* Solubility screening

* Oral liquids

* Cyclodextrin based

Consulting Support

* Formulation development

* Project management

* Clinical supply chain management

* Vendor selection and oversight

* Regulatory assistance

* Due diligence

WWW.VELESCOPHARMA.COM

UNITHER PHARMACEUTICALS

755 Jefferson Road

Rochester, New York 14623 USA

Tel: +1 (585) 475-9000; Fax: +1 (585) 272-3905

Beth Totin, Commercial Director North America

(215) 696-1440

E-mail: beth.totin@unither-pharma.com

Web: www.unither-pharma.com

VITAL STATISTICS

Year Founded: 1993

Number of Employees: 1,300

Key Personnel: Eric Goupil, CEO

Facilities: 6 Manufacturing Sites (France, US and Brazil) 3 Commercial Offices (France, Brazil and China) 1 R&D Center (France)

WHO WE ARE

Unither Pharmaceuticals is a global leader in developing and manufacturing single unit dose pharmaceutical products, using sterile blow-fill-seal (BFS) and stick pack technologies. Our unit dose solutions enable line extensions and product differentiation that support modern on-the-go lifestyles, with the potential to improve medication dosing safety and adherence.

Unither constantly strives to provide our customers with innovative, competitive and sustainable solutions while always taking patient needs into account. With our experience and technology, we can assist our customers at every stage of the development process to help ensure their product's success.

MAJOR MARKETS

Unither Pharmaceuticals is the global leader in sterile unit dose contract manufacturing. We provide expertise utilizing innovative and niche technologies such as sterile unit dose blow-fill-seal technology (BFS), liquid stick pack, powder stick pack, oral liquids and suspensions, oral solid dose, suppositories, pessaries, orodispersible solutions, and extended release formulations. Unither produces over 2.5 billion BFS doses and 400 million liquid stick packs annually, sold in more than 100 countries. In addition to providing manufacturing services, Unither offers R&D services specialized in formulation development for innovative dosage forms.

SERVICES OFFERED

* Research & Development

** Drug Development

** Analytical Services

* Formulation

** Oral Liquids and Suspensions (immediate and extended release)

** Oral Solids (immediate and sustained release)

** Sterile Liquids (non-parenteral)

* Fill-Finish Liquid and Solid Dose

** Clinical Trial and Commercial Scale Manufacturing

** Clinical and Commercial Packaging

** DEA licensed products

** Ophthalmic and respiratory products

WWW.UNITHER-PHARMA.COM

UPM Pharmaceuticals, Inc.

501 5th Street

Bristol, TN 37620

Tel: 423-989-8000

E-mail: info@upm-inc.com

Web: www.upm-inc.com

VITAL STATISTICS

Year Founded: 1997

Number of Employees: 265

Key Personnel: John M. Gregory, Chairman and CEO of Gregory Pharmaceutical Holdings; Jim Gregory, President & CEO of UPM Pharmaceuticals; Ed Scholtz, Ph.D., Vice President, Research & Development; John Bowles, Vice President, General Counsel; Frank Sorce, Vice President, Business Development; Patrick Hatem, Vice President, Manufacturing; Dan Rutledge, Vice President of Quality Assurance; Herschel Blessing, Vice President, Inventory Management; Chris Curtin, COO; Daniel Dixon, Vice President, Quality Control

WHO WE ARE

UPM Pharmaceuticals is a Bristol Tennessee based contract development and manufacturing organization (CDMO) serving the pharmaceutical and biotechnology industries. UPM provides high quality pharmaceutical drug development services that include formulation development, cGMP manufacturing and packaging, analytical method development and testing from concept through commercialization. UPM is characterized by its strict sense of quality, timeliness, sound scientific fundamentals, and affordability with which we complete all our projects. We focus on drug development and manufacturing for dosages with oral routes of administration in solid forms such as capsules and tablets, and semi-solid creams and ointments.

Scientific Expertise--UPM's scientific team includes some of the industry's best analytical chemists, formulators, and manufacturing specialists. Our experienced scientists provide innovative ideas and guidance to address our clients' unique product development challenges such as, low dose content uniformity, high dose compressibility, controlled drug release rates and experimental designs for limited API availability.

Rapid and Responsive Turnaround--Our scientists and managers utilize daily planning meetings and a master scheduling process to ensure that every project will be completed on time, every time.

Quality Assurance Documentation--Our highly experienced quality assurance personnel implement complete cGMP quality systems that support formulation development, cGMP batch manufacturing, and analytical testing.

MAJOR MARKETS

Formulation Development

* Solid Oral Dosage Forms

* Creams and Ointments

* Coating

* Controlled Substances

* Brevi-Batch[R]

cGMP Manufacturing

* Concept to Commercialization

* Wet/Dry Granulation

* Roller Compaction

* Tableting

* Capsule Filling

* Direct API into Capsules

* % Relative Humidity Control

* Bi-layer Tableting

* DEA-controlled substances (CII-CV) manufacturing

Analytical Services

* HPLC Based

* Full ICH Stability Conditions

* Dissolution Testing

* uHPLC

* DSC&TGA

* Particle Size Analysis

* Microbial Testing

* ICP Mass Spectrometry

DEA Licensed/FDA Inspected

WWW.UPM-INC.COM

Valsynthese SA

Societe Suisse des Explosifs Group

Fabrikstrasse 48

3900 Brig

Switzerland

Tel: +41 27 922 71 11

Fax: +41 27 922 72 00

E-mail: info@valsynthese.ch

Web: www.valsynthese.ch

VITAL STATISTICS

Year Founded: 1894

Number of Employees (Group): 550

Key Personnel: Dr. Mara Guzzetti, Head of Fine Chemicals

Gilles de Preux, Chief Executive Officer

WHO WE ARE

Valsynthese is a subsidiary of Societe Suisse des Explosifs Group. Since its foundation in 1894, the group has acquired broad experience in the field of civil explosives, and since the seventies has gradually developed its expertise into hazardous and high energetic chemistry. Valsynthese is devoted to delivering high quality services to the pharmaceutical and chemical industry.

SERVICES OFFERED

Valsynthese offers custom synthesis and contract manufacturing of chemical intermediates and APIs. The company provides customers with complete solutions from process development to industrial production and from preclinical to commercial quantities. Services include full regulatory support from process validation, stability testing to preparation of documents, such as CMC document and Drug Master File, required for registration. Valsynthese is committed to ever greater levels of achievement in environmental and safety, as well as quality and regulatory compliance excellence.

Valsynthese core expertise in hazardous and high energetic chemistry comprises the following specific reactions: Bromination, Chlorination, Reaction with high pressure gasses such as isoprene, Nitration, Oxidation, Azide chemistry, Hydrogenation, Grignard and Nitroglycerine formulations.

Recently Valsynthese has broadened its technology platform with Phosgene chemistry. The versatility of Phosgene chemistry opens the door to a large range of new syntheses. Continuous in situ generation of Phosgene guarantees a high level of safety when producing on a commercial scale.

From development to production, Valsynthese matches the quality standards required by its customers. Valsynthese operates under two quality systems: cGMP certified by Swissmedic, the national Health Authority, or ISO 9001:2008 certified by SQS.

Valsynthese valorises its customers by providing high level services based on a competent and experienced human capital fully committed to developing competitive solutions in a safe environment with a strong ethical responsibility. Valsynthese is the value added key partner for its customers in the pharmaceutical and chemical industry.

WWW.VALSYNTHESE.CH

Vetter Pharma International GmbH

Eywiesenstrasse 5

88212 Ravensburg, Germany

Tel: +49-751-3700-0

Fax: +49-751-3700-4000

Web: www.vetter-pharma.com

E-mail: info@vetter-pharma.com

Contact: Oskar Gold

VITAL STATISTICS

Year Founded: 1950

Number of Employees: 4,400

Key Personnel: Oliver Albrecht, managing director; Thomas Otto, managing director; Peter Soelkner, managing director

WHO WE ARE

Vetter is a leading contract development and manufacturing organization (CDMO) that specializes in the aseptic filling of syringes, cartridges and vials. The company has extensive experience with biologies and other complex compounds, including monoclonal antibodies, peptides, interferons and vaccines. Collaborating with pharma/biotech clients worldwide, Vetter supports products from preclinical development through global market supply. Through its U.S. and European facilities, Vetter Development Service provides state-of-the-art support for early-stage products, with seamless transfer at Phase III to Vetter Commercial Manufacturing for large-scale production. The company offers state-of-the-art technology and innovative processes to promote product quality and maximize API yield.

MAJOR MARKETS

Europe, North America and Asia Pacific

SERVICES OFFERED

Vetter Development Service specializes in taking complex compounds from preclinical development through market launch. It provides:

* Formulation support

* Process development

* Clinical trial manufacturing

* Analytical services

* Regulatory support

Vetter Pharma International USA Inc. 10 W. Algonquin Road Des Plaines, IL 60016, USA Tel: +1-847-581-6888 Fax: +1-847-581-6880 E-mail: infoUS@vetter-pharma.com Contact: Troy Carpenter

Vetter Commercial Manufacturing provides Phase III manufacturing through global market supply, featuring:

* Fill and finish

* Analytical services

* Regulatory support

* Product life cycle management

Vetter Packaging Solutions helps clients match their product with the appropriate drug-delivery system (primary packaging); secondary packaging, such as cartoning or blister packing; and packaging services, such as pen-system assembly. It provides:

* Customized packaging development

* Specialized technologies

* Packaging services

* Serialization services

* Logistic services

WWW.VETTER-PHARMA.COM
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Publication:Contract Pharma
Article Type:Directory
Geographic Code:100NA
Date:Dec 15, 2018
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