Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Methotrexate Injection USP in both multi-dose and single-dose vial formats, the company said in an exchange filing on April 16.
The approval covers Methotrexate Injection USP, 50 mg/2 mL (25 mg/mL) multi-dose vials and 1 g/40 mL (25 mg/mL) single-dose vials, which are therapeutically equivalent to the reference listed drug (RLD).
Methotrexate is a folate analog metabolic inhibitor used in the treatment of various oncology and autoimmune conditions, including acute lymphoblastic leukemia, non-Hodgkin lymphoma, osteosarcoma, breast cancer, and rheumatoid arthritis, among others.
The company stated that the approved product will expand its injectable portfolio in the US market, which remains a key focus area for growth. Alembic continues to strengthen its presence in regulated markets through a steady pipeline of complex generics and specialty products.
With this latest approval, Alembic now has a cumulative total of 236 ANDA approvals from the USFDA, including both final and tentative approvals, reflecting its consistent progress in building a robust product pipeline.
Alembic Pharmaceuticals, part of the Vadodara-based Alembic Group, is a vertically integrated pharmaceutical company with a strong presence across formulations, active pharmaceutical ingredients (APIs), and contract manufacturing, catering to both domestic and international markets.
Shares of Alembic Pharmaceuticals were trading at ₹88.85, up ₹0.68 or 0.77% in today’s session.