Alembic Secures USFDA Approval for Gilenya Generic
Vadodara: Alembic Pharmaceuticals Limited has received final approval from the US Food and Drug Administration (USFDA) for its Fingolimod Capsules, 0.5 mg, strengthening its generics portfolio in the US market.
The approval has been granted for the company’s Abbreviated New Drug Application (ANDA), with the product considered therapeutically equivalent to the reference listed drug (RLD), Gilenya Capsules, 0.5 mg, developed by Novartis Pharmaceuticals Corporation.
Fingolimod is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in patients aged 10 years and above. Patients are advised to refer to the product label for detailed indications.
The Fingolimod Capsules, 0.5 mg segment has an estimated market size of US$145 million for the twelve months ending December 2025, according to IQVIA data, reflecting strong market potential.
With this latest approval, Alembic Pharmaceuticals has achieved a cumulative total of 237 ANDA approvals from the USFDA, including 219 final approvals and 18 tentative approvals.
Alembic Pharmaceuticals Limited, headquartered in India, is a vertically integrated research and development-driven pharmaceutical company with a legacy dating back to 1907. The company manufactures and markets generic pharmaceutical products globally, supported by state-of-the-art research and manufacturing facilities approved by regulatory authorities across developed markets, including the USFDA. It is also a leader in India’s branded generics segment, with a field force of over 5,500 and well-recognized brands among doctors and patients.
