Aurobindo Pharma is currently amongst the top gainers on the BSE, hitting a monthly high at Rs.793, up 4.5%.

The company announced today morning that it has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Rosuvastatin Calcium Tablets, 5 mg (base), 10 mg (base), 20 mg (base) and 40 mg (base).

Aurobindo was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification, therefore, Aurobindo is eligible for 180 days of generic drug shared exclusivity. The product is launched in the US market.

Rosuvastatin Calcium Tablets is an antihyperlipidemic to prevent cardiovascular disease. The approved product has an estimated market size of US$ 6.7 billion for the twelve months ending May 2016 according to IMS.

This is the 112th ANDA (including 19 tentative approvals) to be approved out of Unit III formulation facility in Hyderabad, India for manufacturing Oral Non-Antibiotic products. Aurobindo now has a total of 274 ANDA approvals (234 Final approvals including 13 from Aurolife Pharma LLC and 40 tentative approvals) from USFDA.