Lannett Company Signs Exclusive Contract Manufacturing Agreement with Wintac Limited; Expands Pipeline with New Dosage Forms.PHILADELPHIA -- Lannett Company, Inc. (AMEX AMEX See: American Stock Exchange :LCI LCI Livable Centers Initiative LCI Life Cycle Inventory LCI Landing Craft, Infantry LCI La Chaine Info (French cable news channel) LCI Lean Construction Institute LCI Lions Club International ), a manufacturer of generic pharmaceuticals, today announced the signing of an exclusive, multi-product contract manufacturing agreement with Wintac Limited, an Indian pharmaceutical company, based in Bangalore. Under the terms of the agreement, Lannett will market in the U.S. certain pharmaceutical ophthalmic and parenteral parenteral /pa·ren·ter·al/ (pah-ren´ter-al) not through the alimentary canal, but rather by injection through some other route, as subcutaneous, intramuscular, etc. par·en·ter·al adj. 1. products produced by Wintac. Lannett will assemble and submit to 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. Abbreviated New Drug Applications abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar (ANDAs) for the products covered in the agreement from data provided by Wintac. "By collaborating with Wintac, we have expanded our pipeline with a number of new product candidates," said Arthur Bedrosian, Lannett's president and chief executive officer. "Importantly, this agreement dovetails with our growth strategy by adding new dosage forms to our existing product offering, which will allow us to participate in new areas of the market. We currently expect to submit the first ANDA ANDA abbr. abbreviated new drug application under this agreement within one year. Initially, we will collaborate on four products and expect to add products later on." Bedrosian said the company is pursuing a variety of other strategic relationships with foreign and domestic manufacturers that complement its internal drug development efforts. He said these initiatives are designed to expand the line of products Lannett offers and help grow future revenue and income. About Wintac: Wintac Limited has won high accolades for their exacting standards and has been approved by AFSSAPS AFSSAPS Agence Francaise de Securite Sanitaire des Produits de Sante -- the French Regulatory Agency regulatory agency Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S. , INVIMA -- the inspection agency of the Columbia Ministry of Health, and is certified to comply with 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: 2000 requirements of DNV DNV Det Norske Veritas DNV Dirección Nacional de Vialidad (Argentina) DNV District of North Vancouver (British Columbia, Canada) DNV Der Norske Veritas UK. The company's plant is a state-of-the-art facility that manufactures small and large parenterals, sterile ophthalmic preparations and sustained release Sustained-release (SR), extended-release (ER, XR, or XL), time-release or timed-release, controlled-release (CR), or continuous-release (CR or Contin capsules. About Lannett Company: Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of indications. For more information, visit Lannett Company's website at www.lannett.com. This news release contains certain forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause Lannett's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include Lannett's ability to successfully develop products, the impact of competition from brand name companies that sell their own generic products or successfully extend the exclusivity period of their branded products, the availability of product liability coverage in the current insurance market, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration and other regulatory authority approvals, acceptance and demand for new pharmaceutical products and new therapies, uncertainties regarding market acceptance of innovative products newly launched, currently being sold or in development, the impact of restructuring of clients, reliance on strategic alliances, exposure to product liability claims, dependence on patent and other protections for innovative products, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Lannett's Annual Report on Form 10K for its fiscal year ended June 30, 2005 and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise. |
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