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

MUMBAI, India, June 25, 2021 /PRNewswire/ -- 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.

References:

¹All brand names and trademarks are the property of their respective owners.

²Market includes brand and all available therapeutic equivalents.

*IQVIA^™ National Sales Perspectives: Retail & Non-Retail, April 2021.

About Glenmark Pharmaceuticals Ltd

Glenmark Pharmaceuticals Ltd. (GPL) is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries. Glenmark's key therapy focus areas globally are respiratory, dermatology and oncology. It ranks among the world's top 50 Generics and Biosimilars companies (Top 50 Company Rankings, 2020, from Informa's Generics Bulletin). The company has been listed in the Dow Jones Sustainability Index (DJSI), under the category of emerging markets for the third consecutive year in a row. DJSI is one of the world's most respected and widely accepted sustainability benchmarks globally with only the top ranked companies in terms of Corporate Sustainability within each industry are featured in the index. For more information, visit www.glenmarkpharma.com

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