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ADVANTAPUREAdvantaPure[R] is designed to anticipate and meet the evolving needs of the pharmaceutical manufacturing industry. AdvantaPure is ISO 9001:2008 certified, and many of its products meet USP Class VI, FDA, NSF, ISO, and European Pharmacopoeia standards. While the company focuses on single use molded manifolds, its fluid transfer products include AdvantaFlex[R] biopharmaceutical pump tubing; platinum cured silicone tubing and reinforced hose; and reinforced PIPE, FEP, and EPDM hose; and BioClosure[R] container closures.
145 James Way
Southampton, PA 18966
Tel: 888-218-6364 or 215-526-2151
Fax: 888-258-4293 or 215-526-2167
info@advantapure.com
www.advantapure.com
ALMAC
Almac provides integrated services enabling accelerated development from research to commercialization. From FDA- and EU-approved facilities, Almac offers API manufacture; formulation and analytical development; clinical and commercial-scale drug product manufacture; primary and secondary packaging/ labeling; EU import testing; QP release and third party logistics with direct distribution to end-users. The company also offers IVRS/IWRS and biomarker discovery and development services.
2661 Audubon Road
Audubon, PA 19403
Tel: +1 (610) 666 9500 (US)
Tel: +44 (0)28 3836 3363 (Europe)
pharmaservices@almacgroup.com
www.almacgroup.com
AMRI
AMRI (NASDAQ:AMRI) is a global contract research and manufacturing organization offering fully integrated drug discovery, development, and manufacturing services to the biotechnology and pharmaceutical industries. AMRI SMARTSOURCING[TM] provides optimum service, knowledge and capability to ensure a better balance of risk and return at every stage of the pipeline. With over 21 years of proven expertise and locations in the U.S., Europe and Asia, AMRI's strategically customized business models offer a better way to a better outcome.
126 Corporate Circle
Albany, NY 12203
Tel: 518-512-2000
Fax: 518-512-2020
info@amriglobal.com
www.amriglobal.com
ASH STEVENS, INC.
Ash Stevens is a contract manufacturing organization (CMO) offering drug substance development and active pharmaceutical ingredients (APIs). With more than 50 years of experience, it has received 12 FDA approvals for innovator small molecule APIs, including four fast-track approvals for oncology drugs. A multi-million dollar expansion completed in 2013 added large-scale capacity to its commercial-scale facility in Riverview, Michigan, which offers process development, cGMP manufacturing, potent compound handling, and comprehensive analytical and regulatory support.
18655 Krause Street
Riverview, MI 48193
Tel: 734-282-3370
jhamby@ashstevens.com
www.ashstevens.com
B. BRAUN MELSUNGEN AG
B. Braun OEM Division offers a broad range of standard products and contract manufacturing services for medical devices and pharmaceutical solutions. Our product line has everything for safe and exact infusion therapy. You'll find an expansive portfolio of infusion and injection solutions, drug admixture, drug delivery and automated infusion systems plus disinfection and hygiene products.
B. Braun Melsungen AG
OEM Division
Carl-Braun-Str. 1
34212 Melsungen
Germany
info-europe@bbraunoem.com
www.bbraunoem.com
BULLARD
Bullard is a manufacturer of high-quality personal protective equipment and systems designed to help protect lives around the world. A leader in respiratory protection equipment, Bullard offers powered airpurifying respirators (PAPRs) and airline respirators specifically designed to meet the demands of pharmaceutical manufacturing applications. Bullard respiratory products meet NIOSH standards and provide high-quality protection to workers worldwide. Stay connected with Bullard on Facebook or visit www.bullard.com.
1898 Safety Way
Cynthiana, KY 41031-9303 USA
Toll-free within USA:
877-BULLARD (285-5273)
www.bullard.com
CANGENE BIOPHARMA
Cangene bioPharma, Inc., d/b/a Emergent BioSolutions, has a proven track record as a world-class provider of commercial contract-manufacturing services. Cangene bioPharma, Inc., located in Baltimore, MD, caters to a diverse group of partners in the pharmaceutical and biotechnology industries. Cangene bioPharma, Inc. focuses primarily on fill/finishing services for vial and syringe presentations in both liquid and lyophilized forms, and produces both commercial and clinical trial products. Cangene bioPharma, Inc.'s regulatory history, proven flexibility, and commitment to quality and continuous improvement make it an excellent choice for pharmaceutical or biotechnology companies looking for value and reliable results through outsourcing.
1111 S. Paca St.
Baltimore, MD 21230
Tel: 1-410-843-5000
www.emergentcontractmanufacturing.com
CATALENT
Catalyst + Talent. From drug and biologic development to delivery technologies to clinical and commercial supply, we are the catalyst for your success. As the #1 global drug development and delivery partner, we have the deepest expertise and the broadest choice of drug delivery technologies to help you get more molecules to market faster, solve bioavailability challenges, enhance therapeutic profiles, optimize dose forms and provide global, reliable supply. Catalent. More products. Better treatments. Reliably supplied. [TM]
14 Schoolhouse Road
Somerset, NJ 08873
Tel: 1-888-SOLUTION
solutions@catalent.com
www.catalent.com
CHEMIC LABS.
Chemic Labs is a contract chemistry organization, FDA registered and DEA licensed, servicing the pharmaceutical, medical device, biotech, veterinary medicine and specialty chemicals industries. We offer CMC method development and validation, extractables & leachables analysis, QC chemistry, bioanalytical sample analysis, cGMP organic synthesis & formulation and high purity excipient manufacturing.
480 Neponset St., Bldg. 7
Canton, MA 02021
Tel: 781-821-5600
Fax: 781-821-5651
www.chemiclabs.com
COATING PLACE
Coating Place is a drug delivery systems, manufacturing and development company specializing in Wurster fluid bed coating. Services include formulation development, technology transfer, scale-up and commercial manufacturing with laboratory support. Our applications include controlled and sustained release, enteric and taste masked coatings. Our facilities process solvent and aqueous formulations. We are DEA registered. Send us your toughest projects.
200 Paoli St.
Verona, WI 53593
Tel: 608-845-5002
Fax: 608-845-9526
info@encap.com
www.encap.com
COLDSTREAM
Coldstream Laboratories is your partner to develop and manufacture parenteral drug products in liquid and lyophilized dosage forms. Unique mobile isolator technology within our FDA-approved sterile manufacturing facility ensures product containment for highly potent compounds. Our skilled staff supports all aspects of the drug development process, including analytical chemistry and pre-formulation/formulation development services. Our onsite microbiology lab offers both method validation and routine micro testing services.
1500 Bull Lea Road Suite 250
Lexington, KY 40511
Tel: 859-977-8600
customerservice@coldstreamlabs.com
www.coldstreamlabs.com
COOK PHARMICA LLC
Cook Pharmica LLC is an integrated contract development and manufacturing organization providing the pharmaceutical and biopharmaceutical industry with drug substance manufacturing from mammalian cell culture, analytical & formulation development, aseptic filling in both vials and syringes, lyophilization, and secondary packaging. Cook Pharmica's mission is to simplify your contract manufacturing needs into one source at one location. Founded in 2004, Cook Pharmica is a privately held, wholly-owned subsidiary of Cook Incorporated.
1300 S. Patterson Drive,
P.O. Box 970
Bloomington, IN 47402-0970
Tel: 877-312-COOK
busdev@cookpharmica.com
www.cookpharmica.com
DPT
DPT is a contract development and manufacturing organization (CDMO) providing companies the best solutions to their sterile and non-sterile drug development and manufacturing needs through innovation, technology, and service. Specializing in semi-solid and liquid dosage forms, DPT has a reputation for quality, unmatched technical expertise, extensive manufacturing capabilities, and an exemplary regulatory compliance record.
318 McCullough
San Antonio, TX 78215
Tel: 210-476-8159
Fax: 210-396-5074
www.dptlabs.com
EI
As a Pharmaceutical Solutionworks, Ei Inc. specializes in formulating, developing and manufacturing topical Pharmaceutical and OTC semi-solids, liquids, and powders. We provide quick, reliable, turn-key services, from concept to finished product, in all package types and sizes including unit dose, sample sizes, and trade sizes. Ei focuses on providing perfect product to help you protect and grow your brand.
2865 North Cannon Blvd.
Kannapolis, NC 28083
Tel: 704-939-4300
www.eisolutionworks.com
FEDERAL EQUIPMENT CO
As a world leader in pharmaceutical process and packaging equipment, Federal Equipment Company has the equipment inventory that contract manufacturers and contract packagers need to win new projects and meet customer expectations. Our inventory is available immediately at a fraction of the price of new equipment. Visit us at www.fedequip.com
8200 Bessemer Ave
Cleveland, OH 44127
Tel: 216-271-3500
Toll free: 800-652-2466
Fax: 216-271-5210
www.fedequip.com
GALLUS BIOPHARMACEUTICALS
Gallus BioPharmaceuticals, based in St. Louis, Missouri and Princeton, New Jersey is a mammalian cell culture contract manufacturing organization (CMO) that offers a unique level of flexibility and strategic appeal to companies seeking to develop and manufacture biologies. We are dedicated to our clients interests, and deliver a high level of quality and reliability evidenced in the number of proteins we consistently advance to clinic, a long history of aseptic filling, tech transfers and the commercial APIs we produce.
St. Louis Headquarters
4766 LaGuardia Drive
St. Louis, MO 63134-3117
Tel: +1 314-426-5000
info@gallusbiopharma.com
www.gallusbiopharma.com
GLOBEPHARMA, INC.
GlobePharma, Inc., celebrating 20 years, specializes in solid dosage form equipment and formulation development lab services. Our product lines include all Scale Portable Blenders, rotary tablet presses, instrumentation, unit dose/bulk powder (with compaction technique), liquid & semi-solid samplers, powder segregation particle-size & flow testers, cleaning validation coupons, remote swabbing/biological sampling tools, manual tablet compaction machines, High Shear Granulators, Cone Mills & used equipment.
2 B & C Janine Place
New Brunswick, NJ 08901
Tel: 732-296-9700
www.globepharma.com
HALO PHARMACEUTICAL
Halo Pharmaceutical is a CDMO that provides scientific, regulatory, manufacturing services and development expertise to help customers bring their products to market quickly, effectively and on budget.
30 North Jefferson Road
Whippany, NJ 07981
Tel: 973-428-4000
17800, rue Lapointe
Mirabel, Quebec
Canada J7J 1P3
Tel: 450-433-7673
services@halopharma.com
www.halopharma.com
HARLAN LABORATORIES
Harlan Laboratories is a leading provider of essential, preclinical and non-clinical contract research, research models, animal diets, and services to the pharmaceutical, biotech, medical device, agrochemical, and chemical industries, as well as universities, government, and other research organizations. Our focus is on providing customers with products and services to optimize the discovery and safety of new medicines and compounds. We have over 3,000 employees in 12 countries, but we act locally, understanding the value of close relationships and collaboration with our customers.
8520 Allison Pointe Blvd., Suite 400
Indianapolis, IN 46250
Tel: 800 793-7287
www.harlan.com
HETERO
With $1 billion in sales, Hetero is among the ten largest pharmaceutical companies in India. Hetero provides API and formulation Custom Pharmaceutical Services. Hetero has over 200 pharmaceutical products from wide range of therapeutic categories. All 20 of Hetero's manufacturing facilities are cGMP compliant, meeting global standards in people, process and systems. Nine sites are FDA approved, including two in the USA. Do you know Hetero? The Hetero CPS Value Proposition: Reliable, Capable, Value Driven
Global Custom Pharmaceutical Services
HETERO USA
1031 Centennial Ave.
Piscataway, NJ 08854
Contact: Paul Sidhu
psidhu@heterousa.com
Tel: +1 646-226-1634
www.heterodrugs.com
HOSPIRA ONE 2 ONE[TM]
Hospira is the world's leading provider of injectable drugs. The company's One 2 One[TM] business is a world leader in the custom development and manufacture of injectable products packaged in vials, prefilled syringes, cartridges, flexible containers and ampoules. One 2 One[TM] offers contract development and manufacturing services at its five worldwide facilities. One 2 One[TM] specializes in the fill-finish of biologies and lyophilization. With over 20 years of contract manufacturing experience, One 2 One[TM] is known for its customer service orientation.
275 North Field Drive
D-0988, Bldg. H-1
Lake Forest, IL 60045
U.S. Phone: 1-224-212-2267
Europe Phone: +44 (0) 1926 835 554
Japan Phone: +81-(0)6-4560-2074
one2one@hospira.com
www.one2onecmo.com
JHP PHARMACEUTICALS
JHP Pharmaceuticals is proud of a 27-year heritage in sterile injectable manufacturing. As a contract manufacturer, JHP partners with global pharmaceutical and biotech companies to provide services including liquid, lyophilized and ophthalmic presentations. JHP has the capability to manufacture small-scale clinical through large-scale commercial products.
Morris Corporate Centre 2
One Upper Pond Road, Bldg. D, 3rd Fl.
Parsippany, NJ 07054
Tel: 1 877-906-7556
Fax: 866-923-4547
jhpcontractservices@jhppharma.com
www.jhppharma.com
JUBILANT HOLLISTERSTIER
Jubilant HollisterStier Contract Manufacturing & Services is an integrated contract manufacturer, able to manufacture sterile injectable, solid and semi solid dosage forms. Our facilities across North America and India provide specialized manufacturing services for the pharmaceutical and biopharmaceutical industries. Fill/Finish; Lyophilization; Multiple Dosage Forms; Certified Project Managers; Regulatory Excellence.
Jubilant HollisterStier Corporate: 3525 N. Regal St.
Spokane, WA 99207
Tel: 509-489-5656
Fax: 509-484-4320
www.jublHS.com
info@jublHS.com
METRICS
Metrics Inc. is one of the most respected CDMOs in the United States. Offering first-time-in-man (FTIM) development, and Phase I, II and III clinical trial material, Metrics has conducted more than 75 FTIM studies for different entities in the past five years while simultaneously producing 700-plus batches of CTM. Metrics also offers full analytical methods development and validation. Metrics is a proud subsidiary of Mayne Pharma, a publicly traded pharmaceutical company in Melbourne, Australia.
1240 Sugg Parkway
Greenville, NC 27834
Tel: 252 752-3800
www.metricsinc.com
MIKART
Since 1975, Mikart has been a recognized leader in providing contract development, manufacturing and packaging services to the pharmaceutical industry. We offer a broad range of capabilities including formulation development, analytical services, solid and liquid dose manufacturing, packaging (bottles, blisters, and multi-laminate pouches) and regulatory services.
1750 Chattahoochee Ave
Atlanta, GA 30318
Tel: 888 4 MIKART
Tel: 404-351-4510
www.mikart.com
NORWICH
With a focus on improving patient outcomes, Norwich Pharma Services is a reliable partner for all stages of a product's lifecycle. Norwich offers customers synchronized outsourced solutions from development to scale-up and commercial manufacturing and clinical research services. For more than 125 years, Norwich has built a reputation for dependable product supply and established an unparalleled history of regulatory compliance.
6826 State Highway 12
Norwich, NY 13815
Tel: 888-674-7979
Fax: 607-335-3100
www.norwichpharma.com
PLATINUM PRESS
Platinum Press manufactures a full range of packaging solutions for the pharmaceutical and medical device sectors. The company has the flexibility to rapidly design and produce printed packaging solutions that meet specific customers' needs, achieving this through state-of-the-art digital, flexographic, lithographic and tension-release technologies. Platinum Press has become particularly well known for its innovative combination products that consolidate two or more printed components into a single unit, such as its popular "Combination Carton."
920 Avenue R, Bldg. 200
Grand Prairie, TX 75050
Tel: 469-733-1506
Fax: 469-733-1510
sales@platinumpress.com
www.PlatinumPress.com
PTI
The largest contract manufacturer and packager of powder products in the world, Pharma Tech Industries (PTI) has been providing product development, manufacturing, packaging, and technology transfer services to leading global pharmaceutical and personal care companies for over 40 years. PTI produces over 300 SKUs of powders, effervescent and solid dose products, capsule filling, cotton swabs, injection-molded components, and medical devices across two cGMP facilities in Royston, GA and Union, MO.
272 West Hancock Avenue
Suite 300D
Athens, Georgia 30601
Tel: 706-353-7200
Fax: 706-353-1555
www.pharma-tech.com
sales@pharma-tech.com
QPSI
QPSI is your Partner for Smarter Solutions[TM]. Leveraging a new Contract Packaging facility, we provide turnkey solutions for needs such as bottling, blistering, pouching, cartoning, carding, cold chain, and controlled substances. Our regulatory-approved infrastructure ensures the highest standards of quality will be met. Contact us today to begin your partnership.
5 Cooper Street
Burlington, NJ 08016
Tel: 609-239-0503
Fax: 609-239-0228
www.QPSIUSA.com
REED-LANE, INC.
Reed-Lane is a pharma contract packaging partner with four main industry specialties: blister packaging, bottling, pouching and convenience vial filling. Reed-Lane's 132,000-sq-ft facility includes over 35 production suites for Rx and OTC packaging, as well as 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 conducts rigorous testing to ensure cGMP and FDA compliance.
359 Newark Pompton Turnpike
Wayne, NJ 07470
Tel: 877-290-1090
Fax: 973-709-1949
info@reedlane.com
www.reedlane.com
RONDO-PAK
Rondo-Pak provides a broad range of quality folding cartons to the pharmaceutical, biotech and medical device industries. The company enjoys a solid reputation among packaging professionals for producing top-of-the-line cartons expediently and at competitive cost. In addition to its headquarters in Norristown, PA, and new manufacturing & warehousing facility in San Juan, Puerto Rico, Rondo-Pak is supported by Medipak Systems' five other global locations in Germany, Switzerland and the Czech Republic.
Tel: 800-254-0731
Fax: 610-666-9755
sales@rondo-pak.com
www.Rondo-Pak.com
RX PHARMA-PACK INC.
Rx PharmaPack is a privately held pharmaceutical contract packaging company providing turnkey solutions for the packaging of solid dose products for the pharmaceutical industry. We can provide for purchasing of all components, including a wide selection of bottle sizes with specified resins/ colorants, cotton/rayon fillers, desiccants, patient inserts, caps with tamper resistant induction seals and screen printed labeling as required. Our services provide convenience, flexibility, and affordability with superior product quality and customer service.
245 Oser Ave.
Hauppauge, NY 11788
Contact: Vincent Albanese
(General Manager)
valbanese@rxpharmapack.com
Tel: 631-436-5500
www.RxPharmaPack.com
SANDOZ
Sandoz is one of the leading companies in production of recombinant proteins, using microbial as well as mammalian cell culture technologies. Sandoz offers contract manufacture in FDA approved facilities in Austria with scales of 1,300L to 40,000L (microbial) and 3,000L-13,000L (mammalian). Excellent technology transfer experience, flexibility of production capabilities and fully integrated services accompanied with a highly skilled and customer-oriented team makes Sandoz an ideal partner in development and cGMP manufacture of recombinant products.
Biochemie Str. 10
Kundl, Austria A-6250
Tel: +43 (0)5338 200 680
www.sandoz.com
SGS
SGS Life Science Services is a leading contract service organization providing analytical development, biologies characterization, biosafety and quality control testing. With the largest network of 19 laboratories in 11 countries, services include: analytical chemistry, microbiology, stability studies, bioanalysis, extractables and leachables, virology, and protein analysis. Additionally, SGS provides clinical trial management (Phase I to IV) and services encompassing bioanalytical testing, data management, biostatistics, and regulatory consultancy.
75 Passaic Avenue
Fairfield, NJ 07004
Tel: 973-244-2435
www.sgs.com/en/Life-Sciences
UPS
Logistics can help your business expand overseas and realize significant opportunities. UPS will partner with you to re-examine the unique processes by which you do business, while allowing you to focus on new product and package development and to cultivate new markets. Grow your business through the power of logistics. Visit thenewlogistics.com/healthcare for more information.
55 Glenlake Pkwy NE
Atlanta, GA 30328
Tel: 404-828-6000
www.thenewlogistics.com/healthcare
VETTER
Filling your clinical development needs Vetter Development Service can help reduce both time to market and production costs. State-of-the-art clinical manufacturing at our Chicago and European facilities, with scale-up and transfer to our large-scale manufacturing facilities, support a streamlined development process. It provides:
* Formulation support
* Process development
* Clinical trial manufacturing
* Analytical service
* Regulatory support
Eywiesenstr. 5
88212 Ravensburg, Germany
For US inquiries: +1-847-581-6888 or infoUS@vetter-pharma.com
For EU inquiries: +49-751-3700-0 or info@vetter-pharma.com
www.vetter-pharma.com
WELLSPRING PHARMACEUTICAL
WellSpring delivers fast, flexible service, attention to detail at every stage and cGMP-compliant manufacturing and packaging expertise to meet the needs of a small biotech company or a multinational pharmaceutical organization. We'll give you the attention you deserve. By emphasizing control over all aspects of our operations, our clients can be assured that products will meet their most rigid specifications. Whether your outsourcing needs include solids, topicals or non-sterile liquids, our commitment to full control ensures that all the manufacturing and environmental controls are in place from beginning to end.
400 Iroquois Shore Rd.
Oakville, ON
L6H 1M5 Canada
Tel: 905-337-4500
Fax: 905-337-7239
www.wellspringcmo.com
XCELIENCE
Xcelience[R] offers a suite of services from preformulation and development through manufacturing and clinical distribution. Entrust all your clinical outsourcing needs by partnering with a single CDMO. Services include preformulation, analytical, method development/validation, formulation development, clinical supplies manufacturing, and clinical supplies packaging and distribution. Xcelience's responsibility is delivering the best science and service with a commitment to quality, cost and speed. For more information, visit us at www.xcelience.com, or call (813) 286.0404.
5415 West Laurel Street
Tampa, FL 33607
+1.813.286.0404
www.xcelience.com
info@xcelience.com
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| Title Annotation: | COMAPANY SHOWCASE |
|---|---|
| Publication: | Contract Pharma |
| Article Type: | Directory |
| Geographic Code: | 1U2NJ |
| Date: | Jun 1, 2014 |
| Words: | 3241 |
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