Alembic Pharma Gains USFDA Nod, Eyes $145 Million Opportunity in US Market

has secured final approval from the US Food and Drug Administration (USFDA) for its Fingolimod Capsules (0.5 mg), a generic version of Gilenya used to treat relapsing forms of multiple sclerosis in patients aged 10 years and above. This approval comes through the Abbreviated New Drug Application (ANDA) route and opens access to a US market estimated at $145 million for the 12 months ending December 2025, highlighting a meaningful revenue opportunity. With this, the company’s total USFDA approvals have reached 237 ANDAs, including both final and tentative approvals, strengthening its presence in the high-value US generics space. Strategically, this development enhances Alembic’s neurology portfolio and reinforces its focus on complex generics, positioning it to capture incremental market share while expanding its global footprint in regulated markets. Disclaimer: This post is for informational purposes only and not a recommendation to buy or sell any securities. I, or my family, associates, or relatives, may have a financial interest in the securities mentioned.