Glenmark Pharma receives USFDA approval for manufacturing blood pressure tablets

These tablets are the generic version of Ziac Tablets, which are manufactured by Teva Branded Pharmaceutical Products R&D, Inc.

Glenmark Pharmaceuticals Limited, the leading pharmaceutical company, announced this morning that it has received ANDA approval from the United States Food & Drug Administration (U.S. FDA) for Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP in the strengths 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg. 

These tablets are the generic version of Ziac Tablets, which are available in the strengths 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg, and are manufactured by Teva Branded Pharmaceutical Products R&D, Inc. 

Hydrochlorothiazide is a thiazide diuretic (water pill) whereas Bisoprolol is a beta-blocker. The combination of Bisoprolol and hydrochlorothiazide is used to treat high blood pressure (hypertension).  

The sales data of IQVIA for the 12 months ending November 2021 shows that the Ziac Tablets, in strengths 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg achieved annual sales of approximately USD 30.3 million. 

With this, the pharma company’s current portfolio comprises 172 products authorized for distribution in the US marketplace and 46 ANDA’s that are pending approval with the USFDA. Moreover, the company continues to identify and explore external development partnerships to enable the growth of its existing pipeline and portfolio. 

At 2.06 pm, the share price of Glenmark Pharmaceuticals Limited was trading at Rs 480.35, down by 1.09 per cent from Tuesday’s closing price of Rs 485.65 on BSE.