Glenmark Pharma receives ANDA approval for Bisoprolol Fumarate and Hydrochlorothiazide Tablets

27 Jan 2022 , 09:56 AM

Glenmark Pharmaceuticals Ltd. has received the final approval by the United States Food & Drug Administration (U.S. FDA) for Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg, the generic version of Ziac®1 Tablets, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg, of Teva Branded Pharmaceutical Products R&D, Inc.

According to IQVIATM sales, data for the 12 months ending November 2021, the Ziac® Tablets, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg market2 achieved annual sales of approximately $30.3 million*.

Glenmark’s current product portfolio includes 172 products authorized for distribution in the U.S. markets, and 46 ANDA’s are pending for approval with the U.S. FDA. Glenmark continues to identify and explore opportunities for external development partnerships to accelerate the growth of its existing supply chain and product portfolio.

Glenmark Pharmaceuticals Limited (Glenmark) is an innovation-driven, global pharmaceutical company with presence across specialty, generics, and OTC businesses and with operations in over 80 countries. Glenmark’s key therapeutic areas of focus are respiratory, dermatology and oncology. It ranks among the world’s top 50 Generics and Biosimilar companies (Top 50 Company Rankings, 2020, from Informa’s Generics Bulletin).

Glenmark Pharmaceuticals Ltd is currently trading at Rs482.10 down by Rs3.55 or 0.73% from its previous closing of Rs485.65 on the BSE. The scrip opened at Rs482 and has touched a high and low of Rs483.25 and Rs477.15 respectively.