Published On: Mon, Oct 19th, 2020

Glenmark Pharmaceuticals receives ANDA approval for Sirolimus Tablets, 0.5 mg, 1 mg and 2 mg

Mumbai, October 19, 2020.

Glenmark Pharmaceuticals Inc., USA (Glenmark) 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.  

According to IQVIATM sales data for the 12 month period ending August 2020, the Rapamune® Tablets, 0.5 mg, 1 mg and 2 mg market2 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. 

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