Glenmark’s Generic Approved by FDA

| By | FDA Approved, Generics, Glenmark
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Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Telmisartan and Hydrochlorothiazide Tablets USP, 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg, a generic version of Micardis® HCT Tablets, of Boehringer Ingelheim Pharmaceuticals, Inc.

According to IQVIATM sales data for the 12 month period ending January 2019, the Micardis® HCT Tablets market achieved annual sales of approximately $40.6 million.

Glenmark’s current portfolio consists of 150 products authorized for distribution in the U.S. marketplace and 52 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.