Alembic Pharmaceuticals has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for fingolimod capsules, 0.5 mg. The development marks a significant addition to the company’s generics portfolio in the United States.

The approved formulation is therapeutically equivalent to Gilenya, originally developed by Novartis Pharmaceuticals Corporation. Fingolimod is a sphingosine 1-phosphate receptor modulator used in the treatment of relapsing forms of Multiple Sclerosis (MS), including clinically isolated syndrome, relapsing-remitting MS and active secondary progressive disease in patients aged 10 years and above.

The drug addresses a substantial market opportunity, with estimated sales of approximately USD 145 million in the 12 months ending December 2025, according to industry data. The approval is expected to enhance access to cost-effective treatment options for patients managing chronic neurological conditions.

With this latest approval, Alembic now holds a cumulative total of 237 ANDA approvals from the US regulator, including 219 final approvals and 18 tentative approvals. The company continues to strengthen its presence in regulated markets through a focus on research-driven generic drug development.

Founded in 1907 and headquartered in India, Alembic Pharmaceuticals Limited is a vertically integrated pharmaceutical firm engaged in the manufacturing and global distribution of generic medicines.