Glenmark Pharma’s arm gets USFDA’s nod for Verapamil

04 Aug 2011 Evaluate

Glenmark Pharmaceuticals subsidiary - Glenmark Generics has been granted final approval for their abbreviated new drug application (ANDA) by the United States Food and Drug Administration (USFDA) for Verapamil extended-release tablets, their generic version of Isoptin SR tablets by Ranbaxy.

Verapamil extended-release tablets are indicating in the management of essential hypertension and for the 12 month period ending March 2011 achieved sales of $52 million.

Glenmark’s current portfolio consists of 72 products authorized for distribution in the US marketplace and over 35 ANDA’s pending approval with the USFDA. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.

Earlier in July, Glenmark Generics had been granted final approval for their ANDA by the USFDA for Nizatidine Capsules and will commence marketing immediately. Nizatidine capsules are Glenmark's generic version of Axid by SmithKline Beecham Corporation and are indicated for up to 8 weeks for the treatment of active duodenal ulcer.

Glenmark Generics is a subsidiary of Glenmark Pharmaceuticals and aims to be a global integrated Generic and API leader. It has an established presence in North America, EU and Argentina and maintains marketing front-ends in these countries.

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