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Alembic Pharmaceuticals Limited ( (IN:APLLTD) ) has issued an update.
Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for Fingolimod Capsules 0.5 mg, a generic version of Novartis’s Gilenya used to treat relapsing forms of multiple sclerosis in patients aged 10 and older. The product targets a U.S. market estimated at $145 million for the year to December 2025, and the approval lifts Alembic’s tally of USFDA-approved ANDAs to 237, underscoring its growing presence in the U.S. generics space and reinforcing its strategy of expanding a complex neurology-focused portfolio.
More about Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Limited is a vertically integrated research-driven pharmaceutical company headquartered in India that manufactures and markets generic drugs globally. The publicly listed firm is a leader in branded generics in India, supported by USFDA-approved research and manufacturing facilities and a large domestic field force that promotes its well-known brands to doctors and patients.
Average Trading Volume: 4,496
Technical Sentiment Signal: Hold
Current Market Cap: 151.3B INR
Learn more about APLLTD stock on TipRanks’ Stock Analysis page.