Alembic Pharmaceuticals Ltd. has received final approval from the US Food and Drug Administration (USFDA) for its Fingolimod Capsules, 0.5 mg, the company announced on Saturday, April 25.
The approval is for the company’s Abbreviated New Drug Application (ANDA), with the product being therapeutically equivalent to Novartis’ reference listed drug, Gilenya Capsules, 0.5 mg.
Fingolimod is indicated for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in patients aged 10 years and above.
According to IQVIA data, the approved drug has an estimated market size of $145 million for the 12 months ended December 2025.
With this approval, Alembic Pharmaceuticals now has a cumulative total of 237 ANDA approvals from the USFDA, including 219 final approvals and 18 tentative approvals.
Alembic Pharmaceuticals is a vertically integrated research and development-focused pharmaceutical company engaged in the manufacture and marketing of generic drugs globally.
The company had already received two USFDA approvals earlier this month. The first one was for its Dapagliflozin tablets in 5 mg and 10 mg strengths, used for treating type 2 diabetes and related cardiovascular conditions. It had an estimated market size of $10.49 billion for the 12 months ending December 2025, as per IQVIA data.
The second approval was for its generic version of Methotrexate Injection, covering Methotrexate Injection USP, 50 mg/2 mL (multi-dose vials) and 1g/40 mL (single-dose vials). Methotrexate Injection is used in the treatment of multiple conditions, including various cancers and autoimmune diseases.
Shares of the company closed over 2% lower at ₹753 on Friday, ahead of the USFDA approval announcement. The stock has gained about 8.5% in the last month, while delivering a negative 14% return over the past year.