Wockhardt to launch generic version of migraine drug Sumatriptan in the US market

Wockhardt Limited Wockhardt Towers | Bandra Kurla Complex Bandra (East) | Mumbai 400 051 | India T: 91-22-2653 4444 | F: 91-22-2653 4242 W: www.wockhardt.com Wockhardt to launch generic version of migraine drug Sumatriptan in the US market Mumbai, February 17, 2009 Pharmaceutical and biotechnology major Wockhardt will be launching Sumatriptan injections in the United States. Wockhardt received the final appr oval from the United States Food & Drug Administration (US FDA) for marketing the injections containing 6mg per 0.5ml Sumatriptan succinate, which is used for treating migraine headaches. Sumatriptan is the generic name for the brand Imitrex, marketed in the United States by Glaxo Smithkline. According to IMS, the total market for Sumatriptan injections in the US is worth $255 million, of which the vials had sales of $27 million. “Injections and other sterile products form an integral part of Wockhardt’s growth strategy in the United States,” said Wockhardt Chairman Habil Khorakiwala. “Sumatriptan injection is the thirteenth sterile product approval for Wockhardt and with a portfolio that includes various sterile dose forms such as solutions, suspensions, powders and specialised delivery systems, Wockhardt’s injections are now used in many clinics and hospitals across the US,” he mentioned. Wockhardt is one of the top 5 companies in the world to have received the highest number of 23 Abbreviated New Drug Approvals [ANDA] by the US FDA for 2008 [source Generics Bulletin 2009]. Wockhardt’s Sumatriptan injections will be launched in the US shortly. The patent on Sumatriptan expired on February 6, 2009 and Wockhardt received the final approval for the product, on the day of patent expiration. The Sumatriptan injections will be manufactured at the US FDA certified formulation plant at Waluj, Maharashtra. The product was developed in-house. Wockhardt is a technology-driven global pharmaceutical and biotechnology major with an innovative multi-disciplinary research and development programme. It has 5 research centres and 15 world-class manufacturing plants dotting various countries and continents that are compliant to international regulatory standards such as the US FDA, MHRA or other global regulatory bodies. It has end -to-end integrated capabilities for its products, starting with manufacture of the oral and sterile API’s, the dosage forms and marketing through its wholly owned subsidiary in the US. Wockhardt has a global footprint including the USA, UK, Ireland, France, and Germany with a multi-ethnic workforce from 14 different nationalities.

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