Glenmark Pharmaceuticals said it has received approval from the US health regulator to market Sirolimus tablets, an immunosuppressant, in the American market. The company’s US-based subsidiary has received final approval from the US Food and Drug Administration (USFDA) for the product which is a generic version of PF Prism CV”s Rapamune tablets, Glenmark Pharmaceuticals said in a statement.
Sirolimus tablets are prescribed for preventing rejection of kidney transplants either alone or with other medications. According to IQVIA sales data for the 12-month period ending August 2020, the Rapamune achieved annual sales of around USD 119.7 million.
Glenmark said its current portfolio consists of 165 products authorised for distribution in the US marketplace and has 45 abbreviated new drug applications (ANDAs) pending with the USFDA for approval. In addition to these internal filings, the company continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio, it added.