Wockhardt launches anti – hypertensive drug Nicardipine injections in USA

Wockhardt Limited | Wockhardt Towers | | Bandra Kurla Complex | Bandra (E) | | Mumbai 400 051 | India | | Tel.: +91-22-2653 4444 | | Fax: +91-22-2653 4242 | Wockhardt launches anti-hypertensive drug Nicardipine injections in USA Mumbai, November 18, 2009 Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing the 25mg/10 ml injection of Nicardipine HCl, which is used for short-term management of hypertension or increased blood pressure. Nicardipine is the generic name for the brand Cardene, marketed in the United States by EKR Therapeutics. The patents covering th is product expired on Nov 17, 2009 and Wockhardt is launching the product immediately. “The injections and other sterile products form an integral part of Wockhardt’s growth strategy in the United States,” said Wockhardt Chairman Habil Khorakiwala. “This is our seventeenth sterile product approval in the US based on a variety of technologies like liquid injections in vials and pre -filled syringes, powder for injection and ophthalmic solutions. Being backward integrated into the Nicardipine API will also he lp us gain competitive advantage”. According to IMS, the total market for Nicardipine injection in the US is over $200 million and is one of the few drugs that are used in injectable form to control hypertension in patients who are unable to receive oral medications. In the US generic pharmaceutical market, Wockhardt has been consistently growing market shares for all its products. In many instances, Wockhardt, by virtue of being amongst the first to market, will gain advantages of being an early entrant. The Nicardipine injections will be manufactured at the US FDA certified formulation plant at Waluj, Aurangabad and it will use API, which is also being manufactured by Wockhardt in its FDA approved plant at Ankleshwar. Both the API and the injections were developed in-house. Wockhardt is one of the few companies with end -to-end integrated capabilities for its products, starting with manufacture of the oral and sterile API’s, the dose forms and marketing through the wholly -owned subsidiary in the US, enabling the company to capture maximum value. About Wockhardt 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 14 world-class manufacturing plants dotting various countries and continents that are compliant to international regulatory standards such as the US FDA, MHRA and 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 US, UK, Ireland and France with a multi-ethnic workforce from 14 different nationalities.

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