Glenmark receives USFDA tentative approval for Nintedanib Capsules

Glenmark Pharmaceuticals has received tentative approval by the United States Food & Drug Administration (U.S. FDA) for Nintedanib Capsules, 100 mg and 150 mg, the generic version of Ofev1 Capsules, 100 mg and 150 mg, of Boehringer Ingelheim Pharmaceuticals, Inc.

According to IQVIATM sales data for the 12 month period ending April 2021, the Ofev 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 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.

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