Glenmark receives USFDA final approval for Sirolimus tablets

The research-led pharmaceutical company, Glenmark Pharmaceuticals Limited, announced today that it has received final approval from United States Food & Drug Administration (USFDA) for Sirolimus tablets, 0.5 mg, 1 mg, and 2 mg.

Sirolimus tablets, 0.5 mg, 1 mg, and 2 mg are the generic version of Rapamune tablets, 0.5 mg, 1 mg, and 2 mg, of PF Prism CV. These tablets are used to prevent the rejection of kidney transplants.

Rapamune tablets reached the annual sales of approximately USD 119.7 million for the 12-month period ending August 2020, according to IQVIATM sales data.

The company currently has 165 products in its portfolio, which are authorised for distribution in the US marketplace with 45 abbreviated new drug applications’ (ANDAs) pending approval with USFDA.

Glenmark Pharmaceuticals earns 41.4 per cent revenue from Glenmark generics, 56.7 per cent from its branded generics, and 1.9 per cent from other products. The company operates in more than 50 countries with its presence across generics, specialty, and OTC business with operations. Its key therapy focus areas globally are respiratory, dermatology, and oncology.

At 12.52 pm, its share was trading 2.03 per cent at Rs 480.9 on BSE. It has a 52-week high of Rs 572.7 and a 52-week low of Rs 168.