Aurobindo Pharma has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Clopidogrel Tablets USP 75mg, which is being launched.
Clopidogrel Tablets USP 75mg is the generic equivalent of Aventis US LLC (Sanfoi’s) Plavix tablets USP 75mg. 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 sale of the product is about $6.4 billion.
The company now has a total of 151 ANDA approvals (123 Final approvals including 1 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA.
Aurobindo Pharma has a product presence in key therapeutic segments like SSPs, cephalosporins, antivirals, CNS, cardio-vascular, gastroenterology, etc. The company is the market leader in semi-synthetic penicillin drugs.
