Wockhardt has received final approval from the US FDA for marketing 75 mg tablets of Clopidogrel bisulfate and a tentative approval for the tablets containing 300 mg 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 US by Bristol-Myers Squibb. Wockhardt will launch the product soon.
Wockhardt will manufacture Clopidogrel bisulfate API in its facility at Ankleshwar, Gujarat and the tablets of Clopidogrel at its facility in Aurangabad. The technology for the API and the tablets were developed in-house.
We have received two ANDA approvals in the last three days. Wockhardt’s rapidly growing presence has been aided in large, by the steady stream of new products, said Dr Habil Khorakiwala, Wockhardt Founder Chairman and Group CEO.
According to IMS Health, the total market for this product in the US was over $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.
EP News Bureau