Akorn-Strides, LLC Announces its First ANDA Approval For Keterolac Tromethamine Injection USP, 15 mg/mL and 30 mg/mL.BUFFALO GROVE, Ill. -- Akorn-Strides, LLC today announced its first ANDA approval for Keterolac Tromethamine Injection USP USP - unique sales point , 15 mg/mL and 30 mg/mL. Akorn-Strides, LLC is a Joint Venture that was formed in 2005 by Akorn, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : AKRX) and Strides Arcolab Limited (NSE NSE - Network Software Environment: a proprietary CASE framework from Sun Microsystems. : STAR)(BSE See Bombay Stock Exchange. BSE See Boston Stock Exchange (BSE). : 532531). The primary mission for the Joint Venture is developing liquid, lyophilized ly·oph·i·lize tr.v. ly·oph·i·lized, ly·oph·i·liz·ing, ly·oph·i·liz·es To freeze-dry (blood plasma or other biological substances). [lyophil(ic) + -ize. and dry powder fill generic injectable products targeting several therapeutic markets with a major focus on anti-infectives, analgesics and CNS See Continuous net settlement. CNS See continuous net settlement (CNS). medicines. The current product portfolio of the Joint Venture, which is funded equally by Akorn and Strides Arcolab, was recently expanded and now includes 29 ANDA's with a total of 53 SKU's, or product line offerings. To date, the Joint Venture has filed for 16 ANDA's. The Joint Venture expects to generate product revenues in 2007 based on this and future product approvals, as well as subsequent product launches. In a joint statement given by Arthur S. Przybyl, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Akorn and Member Manager of Akorn-Strides, LLC and Arun Kumar, Vice Chairman and Managing Director of Strides Arcolab and Member Manager of Akorn-Strides, LLC, "We are excited to announce this milestone event for our first product approval. Congratulations to all members of the Joint Venture Team on our first product approval." About Akorn, Inc. Akorn, Inc. manufactures and markets sterile specialty pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois and Somerset, New Jersey Somerset is a census-designated place and unincorporated area located at the eastermost section within Franklin Township, in Somerset County, New Jersey. As of the United States 2000 Census, the CDP population was 23,040. Somerset housed one of the first Marconi Wireless Stations. and markets and distributes an extensive line of hospital and ophthalmic pharmaceuticals. Additional information is available at the Company's website at www.akorn.com. About Strides Arcolab Limited Strides, listed on the Bombay Stock Exchange Bombay Stock Exchange (BSE) See: National Stock Exchange; Mumbai stock exchange. Limited (532531) and National Stock Exchange of India Limited (STAR), is one of India's largest exporters of branded generic pharmaceutical products. Strides manufactures pharmaceuticals formulations in various dosage forms, including capsules, tablets, liquid injectables and is one of the world's top five manufacturers of softgel capsules. Strides also has the only globally dedicated softgel facility for hormones. In addition, Strides undertakes contract research and the manufacturing of specialty chemicals for various multinational companies. Strides has a major presence in various developing countries such as Africa, Latin America and Asia as well as in developed markets such as the U.S., Canada and part of Europe. Strides is one of the largest Indian supplier of institutionally funded aid projects and is an approved supplier to the Global Drug Facility, UNICEF UNICEF (y `nĭsĕf'), the United Nations Children's Fund, an affiliated agency of the United Nations. , and MSF amongst others.
Strides has 14 manufacturing plants spread across the U.S., Brazil, Mexico, Italy, Poland, Singapore and India. This broad manufacturing network facilitates partnering with global organizations ranging from UNICEF and WHO-Global Drug Facility to European and American pharmaceutical multinationals, private labelers and distribution chains. Strides has product registrations in over 37 countries around the world and has earned ISO (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 9001, ISO 14001 and GMP GMP (guanosine monophosphate): see guanine. accreditations including USFDA USFDA United States Food & Drug Administration . Strides employs approximately 1,700 people across the globe. Strides also has a marketing presence in over 50 countries. Materials in this press release may contain information that includes or is based upon forward-looking statements within the meaning of the Securities Litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. Reform Act of 1995. Forward-looking statements give our expectations or forecasts of future events. You can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe," and other words and terms of similar meaning in connection with a discussion of future operating or financial performance. In particular, these include statements relating to future steps we may take, prospective products, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results. Any or all of our forward-looking statements here or in other publications may turn out to be wrong. They can be affected by inaccurate assumptions or by known or unknown risks and uncertainties. Many such factors will be important in determining our actual future results. Consequently, no forward-looking statement can be guaranteed. Our actual results may vary materially, and there are not guarantees about the performance of our stock. Any forward-looking statements represent our expectations or forecasts only as of the date they were made and should not be relied upon as representing our expectations or forecasts as of any subsequent date. We undertake no obligation to correct or update any forward-looking statements, whether as a result of new information, future events or otherwise, even if our expectations or forecasts change. You are advised, however, to consult any further disclosures we make on related subjects in our reports filed with the SEC. In particular, you should read the discussion in the section entitled "Cautionary Statement Regarding Forward-Looking Statements" in our most recent Annual Report on Form 10-K, as it may be updated in subsequent reports filed with the SEC. That discussion covers certain risks, uncertainties and possibly inaccurate assumptions that could cause our actual results to differ materially from expected and historical results. Such factors include, but are not limited to, risks and uncertainties relating to the resolution of the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. compliance issues at our Decatur, Illinois manufacturing facility. Other factors besides those listed there could also adversely affect our results. |
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