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Glenmark Pharmaceuticals Receives ANDA approval for Sirolimus tablets

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Glenmark Pharmaceuticals Inc, USA (Glenmark) 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 Rapamune1 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 US marketplace and 45 ANDA’s pending approval with the US 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.

1 All brand names and trademarks are the property of their respective owners.

2 Market includes brand and all available therapeutic equivalents

* IQVIATM National Sales Perspectives: Retail & Non-Retail, August 2020

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