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

By ANI | Updated: June 25, 2021 11:40 IST

Glenmark Pharmaceuticals Ltd (Glenmark) 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 Ofev®1 Capsules, 100 mg and 150 mg, of Boehringer Ingelheim Pharmaceuticals, Inc.

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Glenmark Pharmaceuticals Ltd (Glenmark) 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 Ofev®1 Capsules, 100 mg and 150 mg, of Boehringer Ingelheim Pharmaceuticals, Inc.

According to IQVIA™ sales data for the 12 month period ending April 2021, the Ofev® Capsules, 100 mg and 150 mg market2 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.

This story is provided by PRNewswire.will not be responsible in any way for the content of this article. (ANI/PRNewswire)

( With inputs from ANI )

Disclaimer: This post has been auto-published from an agency feed without any modifications to the text and has not been reviewed by an editor

Tags: Glenmark pharmaceuticals ltdUnited states food & drug administration
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