Glenmark gets USFDA’s tentative approval for Nintedanib Capsules

25 Jun 2021 Evaluate

Glenmark Pharmaceuticals has received tentative approval by the United States Food & Drug Administration (USFDA) for Nintedanib Capsules, 100 mg and 150 mg, the generic version of Ofev 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 USFDA. 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.

Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.

Glenmark Pharma Share Price

1992.70 -8.35 (-0.42%)
28-Jan-2026 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1610.15
Dr. Reddys Lab 1224.30
Cipla 1328.25
Zydus Lifesciences 896.60
Lupin 2121.65
View more..
Register Now to get our Free Newsletter & much more!

© 2026 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt. Ltd.

×