Aurobindo Pharma gains on USFDA approval for Rosuvastatin calcium tablets

Aurobindo Pharma has moved higher by 4% to Rs 788 on the BSE after the company said that it has received nod from the US drug regulator to manufacture and market Rosuvastatin Calcium tablets.

The company has received final approval the US Food & Drug Administration (USFDA) to manufacture and market Rosuvastatin Calcium tablets 5 mg, 10 mg, 20 mg and 40 mg, a generic equivalent of Crestor tablets, indicated for hyperlipidemia or mixed dyslipidemia, Aurobindo Pharma said in news release.

Rosuvastatin Calcium Tablets 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 hypercholesterolemia and mixed dyslipidemia.

According to IMS, the approved product has an estimated market size of US$ 6.7 billion for the twelve months ending May 2016.

Aurobindo Pharma said it 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.

At 10:13 AM, the stock was up 3.4% at Rs 785 on the BSE. A combined 831,028 equity shares changed hands on the counter on the BSE and NSE so far.

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