Glenmark receives two ANDA approvals from USFDA

28 Mar 2016 Evaluate

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.03 mg, the generic version of Yasmin Tablets of Bayer Healthcare Pharmaceuticals Inc. (Bayer) and for Levonorgestrel Tablet, 1.5 mg, the generic version of Plan B One-Step Tablet of Teva Branded Pharmaceutical Products R&D, Inc., for over-the-counter (OTC) use as recommended in the submitted labeling.

According to IMS Health sales data for the 12 month period ending January 2016, the Yasmin market achieved annual sales of approximately $131.7 million while the Plan B One-Step Tablet OTC market achieved annual sales of approximately $45.2 million.

Glenmark’s current portfolio consists of 112 products authorized for distribution in the US marketplace and 57 ANDA’s pending approval with the USFDA.



Glenmark Pharma Share Price

1970.75 -25.15 (-1.26%)
23-Jan-2026 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1631.65
Dr. Reddys Lab 1235.15
Cipla 1314.85
Zydus Lifesciences 881.95
Lupin 2137.15
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.

×