Alembic Pharmaceuticals gets FDA approval for fingolimod generic, 237th ANDA

Business Apr 27, 2026

Alembic Pharmaceuticals just got final approval from the US Food and Drug Administration to sell its fingolimod capsules, a generic version of Novartis's Gilenya, used to treat relapsing multiple sclerosis in people 10 and older.
This marks its 237th ANDA approval, a big milestone for the company.

Alembic opens German subsidiary, FDA-approved methotrexate

Alembic is also stepping into Europe with a new German subsidiary, aiming to grow its reach in regulated markets.
Plus, it recently scored another US Food and Drug Administration approval for methotrexate injection USP in multiple dosage formats, showing it is serious about broadening its medicine lineup.