Glenmark Pharma receives USFDA approval for Fingolimod

Glenmark Pharmaceuticals Inc. (USA) today received the final approval by United States Food and Drug Administration (USFDA) for Fingolimod capsules, 0.5 mg, which is used to treat relapsing forms of multiple sclerosis. It is the generic version of Gilenya capsule, 0.5 mg of Novartis Pharmaceuticals Corporation.

According to IQVIA sales data for 12-month period ending in April 2020, Gilenya capsules, 0.5 mg sold approximately $2.1 billion.

Glenmark Pharmaceuticals Ltd is research-led pharma company with its presence across the globe with operations in over 50 countries. The company’s current portfolio consists of 164 products which are authorised for distribution in US market. It also has 44 ANDA’s pending approval with USFDA. Glenmark’s key therapy areas are respiratory, dermatology and oncology.

Glenmark’s share dropped to Rs 188 on March 23 after the government declared nationwide lockdown and has recovered strongly by 118% reaching to Rs 411.4 on June 18, 2020. The stock has 52-week high of Rs 519.8 and 52-week low of Rs 168 on BSE.