Hyderabad: City-based Aurobindo Pharma Limited has received the final approval from the US Food and Drug Administration (USFDA) to manufacture and market rosuvastatin calcium tablets in 5 mg, 10 mg, 20 mg and 40 mg (base) strengths.

Aurobindo is eligible for 180 days of generic drug shared exclusivity. The product is launched in the US market. The approved product has an estimated market size of $6.7 billion for the 12 months ending May 2016, according to IMS.

A bioequivalent and therapeutically equivalent to US-based IPR Pharmaceutical Inc’s cholesterol-lowering drug Crestor. Rosuvastatin calcium tablet is an antihyperlipidemic to prevent cardiovascular disease.

It is used to reduce elevated total-C, LDL-C, ApoB, non-HDL-C, and TG levels and to increase HDL-C in patients with primary hyper-cholesterolemia and mixed dyslipidemia.

This is the 112th ANDA, including 19 tentative approvals, to be approved out of Aurobindo’s formulation facility in Hyderabad for manufacturing oral non-antibiotic products. Aurobindo now has a total of 274 ANDA approvals from the USFDA.

Aurobindo Pharma’s scrip ended the trade at Rs 797.95 on the BSE on Wednesday, up 5.09 per cent, over the previous close of Rs 759.30.