Glenmark receives US FDA nod for anti-inflammatory drug indomethacin

Indomethacin extended-release capsule (75 mg) is generic version of Iroko Pharmaceuticals' Indocin

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Glenmark office

BS B2B Bureau Mumbai

Last Updated : Jun 27 2017 | 2:57 PM IST

Glenmark Pharmaceuticals has been granted final approval by the US Food & Drug Administration (FDA) for indomethacin extended-release capsule (75 mg), the generic version of Indocin SR capsule of Iroko Pharmaceuticals LLC. Indomethacin is a non-steroidal anti-inflammatory drug commonly used as a prescription medication to reduce fever, pain, stiffness, and swelling from inflammation.

According to IMS Health sales data for the 12 month period ending April 2017, the Indocin SR extended-release capsule (75 mg) market achieved annual sales of approximately $ 6.3 million.

Glenmark’s current portfolio consists of 118 products authorised for distribution in the US marketplace and 67 ANDA’s pending approval with the US 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.