Glenmark Receives ANDA Approval for Indomethacin

Glenmark Pharmaceuticals has been granted final Abbreviated New Drug Application (ANDA) approval by the United States Food & Drug Administration (U.S. FDA) for Indomethacin Extended-Release Capsules USP, 75 mg, the generic version of nonsteroidal anti-inflammatory drug (NSAID) Indocin SR Extended-Release Capsules, 75 mg of Iroko Pharmaceuticals.

According to IMS Health sales data for the 12 month period ending April 2017, the Indocin SR Extended-Release Capsules, 75 mg market achieved annual sales of approximately $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.