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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

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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.

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