Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) 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. The company would be launching the product immediately.
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.
Wockhardt will be manufacturing the Clopidogrel bisulfate API in its facility at Ankleshwar, India and the tablets of Clopidogrel at its facility in Aurangabad, India. The technology for the API and the tables were developed in-house.
Wockhardt is one of the few companies with end to end integrated capabilities for its products, starting with the manufacture of the oral and sterile API’s , the dose forms and marketing through wholly owned subsidiary in the US, enabling the company to capture maximum value.
