The lead drug Glenmark Pharmaceuticals said on Friday that it had received a final nod from the health regulator for Fingolimod capsules.
The capsules are used in the treatment of adult patients with recurrent forms of multiple sclerosis.
"Glenmark Pharmaceuticals Inc, USA has received final approval from the United States Food and Drug Administration (USFDA) for Fingolimod capsules, 0.5 mg, generic versions of Gilenya capsules, 0.5 mg, of Novartis Pharmaceuticals Corporation, "said the main drug in a file with the BSE.
According to IQVIA sales data for the 12-month period ending in April 2020, the Gilenya 0.5 mg capsule market achieved annual sales of approximately $ 2.1 billion, said the company.
Glenmark's current portfolio includes 164 products that are authorized for distribution in the US market and 44 abbreviated new drug requests pending approval by the USFDA.
Glenmark Pharmaceuticals shares were trading at Rs 411.20 a piece on BSE in morning trading, up 1.44% from their previous close.