Aurobindo Pharma Ltd. announced that it had received final approval from the US FDA to manufacture and market Clopidogrel tablets, USP 75 mg, covered under ANDA 090540, which is being launched.
Clopidogrel tablets USP 75 mg is the generic equivalent of Aventis US LLC (Sanofi)'s Plavix tablets USP 75 mg.
The product falls under the cardio-vascular (CVS) therapeutic category and is indicated for the prevention of atherothrombotic events in patients who have had a myocardial infarction or ischaemic stroke, or who have established peripheral arterial disease. The annual sales of the product is around $6.4 billion.
The product has been approved out of unit III formulations facility in Hyderabad, India.
At the BSE, Aurobindo Pharma shares are currently trading at Rs.107.00, up 0.80 percent from the previous close.
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