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Glenmark Pharma receives USFDA approval for Sirolimus tablets

expresspharmaOctober 21, 2020

Tag: Glenmark , Sirolimus tablets , FDA

Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (US FDA) for Sirolimus Tablets, 0.5 mg, 1 mg and 2 mg, the generic version of Rapamune Tablets, 0.5 mg, 1 mg and 2 mg, of PF Prism CV.

According to IQVIA 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 authorised for distribution in the US marketplace and 45 ANDA’s pending approval with the US FDA.

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