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Alembic Pharmaceuticals gets USFDA’s final approval for Fingolimod Capsules
Apr-25-2026

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fingolimod Capsules, 0.5 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Gilenya Capsules, 0.5 mg of Novartis Pharmaceuticals Corporation (Novartis). Fingolimod is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in patients 10 years of age and older. 

Fingolimod Capsules, 0.5 mg, have an estimated market size of $145 million for twelve months ending December 2025 according to IQVIA. Alembic has a cumulative total of 237 ANDA approvals (219 final approvals and 18 tentative approvals) from USFDA.

Alembic Pharmaceuticals is involved in manufacturing and marketing of India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities.


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