Wockhardt to launch Leveiracetam, a generic version of epilepsy drug 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 Leveiracetam, a generic version of epilepsy drug in the US market Mumbai, February 12, 2009 Pharmaceutical and biotechnology major Wockhardt will be launching Levetiracetam tablets in the United States. Wockhardt Limited received ap proval from the United States Food & Drug Administration (US FDA) for marketing the tablets containing 250mg, 500mg, 750mg and 1gm Levetiracetam which is used for treating various kinds of epileptic seizures. Levetiracetam is the generic name for the brand Keppra, marketed in the USA by UCB. According to IMS, the total market for Levetiracetam tablets in the US is $1.07 billion. “CNS drugs, especially anti-epileptic drugs form a significant portion of Wockhardt’s growing product portfolio in the USA,” said Wockhardt Chairman Habil Khorakiwala. “With nearly sixty products now in the market, we are continuing to strengthen Wockhardt’s US business by filing several ANDA’s, including technologically challenging products, all indigenously developed by Wockhardt’s R&D team,” he added. 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 Levetiracetam tablets will be launched in the US shortly. In the prescription generic pharmaceutical market, Wockhardt has been consistently growing market shares for all its products. The tablets 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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