Glenmark bags USFDA nod for generic version of Ziac Tablets
Mumbai: Glenmark Pharmaceuticals Inc., USA has received final approval from the United States Food & Drug Administration (USFDA) 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 product is a generic version of Ziac 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.
Bisoprolol and hydrochlorothiazide combination is used to treat high blood pressure (hypertension).
According to IQVIA sales data for the 12 month period 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 authorized for distribution in the U.S. marketplace and 46 ANDA's pending approval with the U.S. 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.
Read also: Glenmark signs licensing agreement with Lotus International to commercialize Ryaltris
Glenmark Pharmaceuticals Limited is a global research-led pharmaceutical company with presence across generics, specialty and OTC businesses and with operations in over 50 countries.
Glenmark's key therapy focus areas globally are respiratory, dermatology and oncology. The company has been listed on the Dow Jones Sustainability Index (DJSI), under the category of emerging markets for four consecutive years in a row; most recently in 2021.
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