Glenmark bags USFDA nod for Nintedanib Capsules
Mumbai: Drug maker, Glenmark Pharmaceuticals Ltd, today announced that the company has received tentative approval from the United States Food & Drug Administration (USFDA) for Nintedanib Capsules, 100 mg and 150 mg.
The product is a generic version of Ofev 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 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.