Glenmark Pharmaceuticals receives ANDA approval for Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg
Mumbai, India, January 27, 2022: Glenmark Pharmaceuticals Inc., USA (Glenmark) has received 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 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 market2 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.
About Glenmark Pharmaceuticals Ltd.
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). 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. DJSI is one of the world’s most respected and widely accepted sustainability benchmarks globally with only the top ranked companies in terms of Corporate Sustainability within each industry being featured in the index. For more information, visit www.glenmarkpharma.com.
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1All brand names and trademarks are the property of their respective owners.
2Market includes brand and all available therapeutic equivalents
*IQVIATM National Sales Perspectives: Retail & Non-Retail, November 2021