Alembic Pharmaceuticals has secured final approval from the US Food & Drug Administration (USFDA) for its Methotrexate Injection USP, available in both 50 mg/2 mL multi-dose and 1g/40 mL single-dose formats. This therapeutically equivalent treatment is indicated for various neoplastic diseases and chronic conditions such as rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and severe psoriasis. This milestone brings the company’s total cumulative ANDA approvals to 236.
Advancing Oncology and Rheumatology Portfolios
On April 16, 2026, Alembic Pharmaceuticals announced a significant addition to its product pipeline with the final USFDA approval for Methotrexate Injection USP. The approved injection is a folate analog metabolic inhibitor, providing a critical therapeutic alternative for patients battling complex conditions. The product is equivalent to the reference listed drug currently marketed by Hospira, Inc.
Broad Therapeutic Applications
The newly approved injection is indicated for a wide range of medical needs. For neoplastic diseases, it serves as a treatment or prophylaxis for conditions including Acute Lymphoblastic Leukemia, Meningeal Leukemia, Non-Hodgkin Lymphoma, Osteosarcoma, Breast Cancer, Squamous Cell Carcinoma, and Gestational Trophoblastic Neoplasia. Additionally, the drug is indicated for chronic autoimmune conditions, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and severe psoriasis.
Growth in US Market Presence
With this latest authorization, Alembic Pharmaceuticals continues to expand its footprint in the generic pharmaceutical market. The company now holds a cumulative total of 236 ANDA approvals from the USFDA, comprising 218 final approvals and 18 tentative approvals. This achievement underscores the company’s commitment to delivering high-quality generic healthcare solutions globally.
Source: BSE
