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Friday, April 25, 2025
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HomeHealthcareGlenmark Pharmaceuticals receives ANDA approval for Metronidazole Vaginal Gel, 0.75%

Glenmark Pharmaceuticals receives ANDA approval for Metronidazole Vaginal Gel, 0.75%

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Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Metronidazole Vaginal Gel, 0.75%, the generic version of MetroGel-Vaginal®1 Gel, 0.75%, of Bausch Health US, LLC.

According to IQVIATM sales data for the 12 month period ending November 2021, the MetroGel-Vaginal® Gel, 0.75% market2 achieved annual sales of approximately $60.4 million*.

Glenmark’s current portfolio consists of 173 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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