Glenmark Pharmaceuticals’ arm gets USFDA’s nod for Sirolimus Tablets

19 Oct 2020 Evaluate

Glenmark Pharmaceuticals’ subsidiary -- Glenmark Pharmaceuticals Inc., USA, has received final approval by the United States Food & Drug Administration (U.S. FDA) for Sirolimus Tablets, 0.5 mg, 1 mg and 2 mg, the generic version of Rapamune 1 Tablets, 0.5 mg, 1 mg and 2 mg, of PF Prism CV. Sales data for the 12 month period ending August 2020, the Rapamune Tablets, 0.5 mg, 1 mg and 2 mg market achieved annual sales of approximately $119.7 million.

Glenmark’s current portfolio consists of 165 products authorized for distribution in the U.S. marketplace and 45 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.

Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.

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