Alembic Pharmaceuticals Limited has obtained final approval from the US Food and Drug Administration (USFDA) for its generic methotrexate injection, representing an important enhancement to its oncology and specialty portfolio. The authorization is for the abbreviated new drug application (ANDA) encompassing essential dosage strengths, such as 50 mg/2 ml multi-dose vials and 1g/40 ml single-dose vials. Hospira has deemed the product therapeutically comparable to the reference listed drug, allowing the company to sell the injectable in the United States, a major global pharmaceutical market. Methotrexate injection is commonly recommended for treating various cancers, including acute lymphoblastic leukaemia, osteosarcoma, and breast cancer, as well as autoimmune diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, and severe psoriasis. The endorsement enhances the firm's position in the regulated U.S. generics market and bolsters its strategy to broaden complex injectable products.