Glenmark Pharma receives ANDA approval for Bisoprolol Fumarate and Hydrochlorothiazide Tablets

The drugs are indicated for treating high blood pressure

Glenmark Pharmaceuticals Inc, USA (Glenmark) has received final approval from the United States Food & Drug Administration (US 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 Ziac1 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 market achieved annual sales of approximately $30.3 million.

Glenmark’s current portfolio consists of 172 products authorised for distribution in the US marketplace and 46 ANDA’s pending approval with the US FDA. 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.