Glenmark Pharma receives ANDA approval for Sirolimus (generic drug)

Generic drug for preventing rejection of kidney transplants

Photo by Michael Longmire on Unsplash

Glenmark Pharmaceuticals announced that it has received approval from the US health regulator to market Sirolimus tablets (0.5 mg, 1 mg and 2 mg), an immunosuppressant, in the US market. The company’s US-based subsidiary has received final approval from the US Food and Drug Administration (USFDA) for the product, a generic version of PF Prism CV’s Rapamune tablets (0.5 mg, 1 mg and 2 mg), 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 months ending August 2020, the Rapamune achieved annual sales of around US$ 119.7 million (approximately Rs 880 crore).

Glenmark said its current portfolio consists of 165 products authorized 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.

Glenmark Pharmaceuticals is a global research-led pharmaceutical company with a presence across generics, specialty, and OTC (over the counter) business with operations in over 50 countries, including India. Glenmark’s key therapy focus areas globally are respiratory, dermatology, and oncology. It is ranked among the top 80 Pharma and Biotech companies globally in terms of revenue (SCRIP 100 Rankings published in the year 2019).


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