Aurobindo Pharma announced Thursday the company has received the final approval from the US Food & Drug Administration (USFDA) to manufacture and market Omeprazole Delayed-release Capsules USP, 10mg, 20mg and 40mg (ANDA 203270).

The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Prilosec Delayed-release Capsules, 10mg, 20mg and 40mg of AstraZeneca Pharmaceuticals.

Omeprazole Delayed-release Capsules are indicated for short-term treatment of active duodenal ulcer in adults. The product has an estimated market size of USD 422 Million for the twelve months ending June 2015 according to IMS.

This is the 43rd ANDA to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-betalactam products. Aurobindo now has a total of 208 ANDA approvals from USFDA.

Shares of the company declined Rs 12.3, or 1.5%, to trade at Rs 805. The total volume of shares traded was 193,784 at the BSE (1.57 p.m., Thursday).