Alembic Pharmaceuticals Secures USFDA Final Approval For Methotrexate Injection USP

Alembic Pharmaceuticals announced on April 16, 2026, that it has received USFDA approval for Methotrexate Injection USP. The approval covers 50 mg/2 mL multi-dose vials and 1 g/40 mL single-dose vials, therapeutically equivalent to the reference listed drug by Hospira.

Product Details

Methotrexate is a folate analog metabolic inhibitor widely used in oncology and autoimmune therapies. It is prescribed for conditions such as acute lymphoblastic leukemia, non-Hodgkin lymphoma, osteosarcoma, breast cancer, rheumatoid arthritis, and severe psoriasis. The approval allows Alembic to market this critical drug in the US, enhancing treatment accessibility.

Strategic Significance

This milestone adds to Alembic’s growing portfolio of USFDA-approved products, now totaling 236. The approval underscores Alembic’s commitment to expanding its footprint in the US generics market, particularly in high-demand therapeutic areas like oncology and immunology. Analysts expect this development to support revenue growth and strengthen Alembic’s competitive positioning.

Market Impact

Alembic’s entry into the US market with Methotrexate Injection is expected to improve patient access to affordable treatment options. The approval also highlights the company’s regulatory expertise and ability to deliver complex formulations for global healthcare needs.

Key highlights

• Alembic Pharmaceuticals receives USFDA final approval for Methotrexate Injection USP
• Approval covers 50 mg/2 mL multi-dose and 1 g/40 mL single-dose vials
• Drug used in oncology and autoimmune conditions including leukemia, lymphoma, breast cancer, and rheumatoid arthritis
• Therapeutically equivalent to Hospira’s reference listed drug
• Adds to Alembic’s 236 USFDA approvals, strengthening US market presence

Sources: Business Upturn, ScanX News, Alembic Pharmaceuticals regulatory filing