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

October 19, 2020 23:30 IST
Tennis player James Blake
Glenmark Pharmaceuticals Inc logo

Mumbai (Maharashtra) [India], October 19 (ANI/PRNewswire): 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 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 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

This story is provided by PRNewswire. ANI will not be responsible in any way for the content of this article. (ANI/PRNewswire)

DISCLAIMER


(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

 

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

Mumbai (Maharashtra) [India], October 19 (ANI/PRNewswire): 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 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 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

This story is provided by PRNewswire. ANI will not be responsible in any way for the content of this article. (ANI/PRNewswire)

DISCLAIMER


(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

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