ANDA Approval Received by Glenmark Pharmaceuticals for Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 1000 mg

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 1000 mg, the generic version of Glumetza® Extended-Release Tablets, 500 mg and 1000 mg, of Salix Pharmaceuticals Inc.

According to IQVIATM sales data for the 12-month period ending September 2019, the Glumetza® Tablets, 500 mg and 1000 mg market2 achieved annual sales of approximately $226.7 million*.

Glenmark’s current portfolio consists of 164 products authorized for distribution in the U.S. marketplace and 44 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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