Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Indomethacin Extended-Release Capsules USP, 75 mg, the generic version of Indocin SR Extended-Release Capsules, 75 mg of Iroko Pharmaceuticals LLC.
According to IMS Health sales data for the 12 month period ending April 2017, the Indocin SR Extended-Release Capsules, 75 mg market1 achieved annual sales of approximately USD 6.3 million.
Glenmark's current portfolio consists of 118 products authorized for distribution in the U.S. marketplace and 67 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
Shares of the company gained Rs 1.05, or 0.17%, to trade at Rs 628.50. The total volume of shares traded was 8,138 at the BSE (9.51 a.m., Tuesday).