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Glenmark receives ANDA tentative nod for Nintedanib Capsules, 100mg and 150 mg

Glenmark Pharmaceuticals Ltd has received tentative approval by the United States Food and Drug Administration (USFDA) for Nentenab Capsules, 100 mg and 150 mg, the generic version of Ofev@1 Capsules, 100 mg and 150 mg, of Beohringer Ingelheim Pharmaceuticals, Inc.

According to IQVIA sales data for the 10 month period ending April 2021, the Ofev@1 Capsules, 100 mg and 150 mg market achieved annual sales of approximately $1.6 billion.

Glenmark’s current portfolio consists of 172 products authorized for distribution in the U.S. marketplace and 44 ANDA’s pending approval with the USFDA. 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.

Medically Speaking Team

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