Pharmaceutical & biotechnology major Wockhardt had received final approval from the US FDA (United States Food & Drug Administration) for marketing 75mg tablets of Clopidogrel bisulfate and a tentative approval for the tablets containing 300mg Clopidogrel bisulfate, which are used to help reduce risk of heart attack or stroke. Clopidogrel is the generic name for the brand Plavix®, marketed in the United States by Bristol-Myers Squibb. Wockhardt is launching the product immediately.
According to IMS Health, the total market for this product in the US was above $ 6,500 million. Prevalence of atherosclerotic diseases is rapidly growing the world over. But by inhibiting the clotting of blood within the blood vessels, it reduces the risk of heart attacks and strokes and is one of the most used pharmaceutical products in the world.
Dr. Habil Khorakiwala, Founder Chairman & Group CEO, Wockhardt, “We have received 2 ANDA approvals in the past 3 days. Wockhardt’s rapidly growing presence has been aided in large, by the steady stream of new products”
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 few players to market technically challenging products has reaped the advantage of being an early entrant.
Wockhardt will be manufacturing the Clopidogrel bisulfate API in its facility at Ankleshwar, India & the tablets of Clopidogrel at its facility in Aurangabad, India. The technology for the API and the tables were developed in-house.
About Wockhardt..!
Wockhardt is a high technology intensive global pharmaceutical and biotechnology company with multi-disciplinary and innovative R & D programmes. It has three research centres globally & manufacturing facilities across India, USA, UK and Ireland.
Wockhardt has a significant presence in USA, Europe and India, with 75 per cent of its global revenues coming from international businesses. With a large pool of Patents and Intellectual Property know how, Wockhardt is home to 578 scientists, of whom 80 are doctorates.
In all, Wockhardt has 164 Patents granted worldwide. In biotechnology research, it has built a competent ‘Concept to Market’ capabilities in all facets of development and manufacture of recombinant biopharmaceuticals. Wockhardt boasts of a multi-ethnic workforce of above 7,900 people from 21 different nationalities.
Plavix® is a registered trademark of Sanofi-Aventis.
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