Glenmark Pharmaceuticals on Friday announced that it has received tentative approval from the United States Food & Drug Administration (USFDA) for Nintedanib Capsules.
Nintedanib Capsules are generic version of Ofev Capsules of Boehringer Ingelheim Pharmaceuticals Inc. According to IQVIA sales data for the 12 month period ending April 2021, the Ofev Capsules 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 said it continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
Shares of Glenmark Pharmaceuticals were trading 0.79% higher at Rs 635.70 on BSE.
Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across generics, specialty and over-the-counter (OTC) business with operations in over 50 countries.
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