Alembic Pharma Secures USFDA Approval for Generic Methotrexate Injection

Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration for its generic Methotrexate Injection USP, a product used in the treatment of several cancers as well as serious autoimmune conditions. The approval, announced on April 16, 2026, covers 50 mg/2 mL (25 mg/mL) multi-dose vials and 1 g/40 mL (25 mg/mL) single-dose vials, giving the Vadodara-based drugmaker another entry into the regulated US generics market.

According to the company, the approved abbreviated new drug application, or ANDA, is therapeutically equivalent to the reference listed drug made by Hospira, Inc. Methotrexate is a folate analog metabolic inhibitor with a wide clinical role in oncology and immunology, and Alembic said the injection is indicated for neoplastic diseases including acute lymphoblastic leukemia, meningeal leukemia, non-Hodgkin lymphoma, osteosarcoma, breast cancer, squamous cell carcinoma of the head and neck, and gestational trophoblastic neoplasia. It is also indicated for rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and severe psoriasis.

The approval adds to Alembic’s steadily expanding US pipeline. In its official release, the company said it now has a cumulative total of 236 ANDA approvals from the USFDA, including 218 final approvals and 18 tentative approvals. That figure underlines the company’s continued push to build scale in the American generics business, where regulatory clearances remain a key growth driver for Indian pharmaceutical exporters.

The development also reflects the continued strength of India’s pharmaceutical manufacturing base in complex and specialty generics. IBEF said the approval is expected to further strengthen Alembic’s presence in oncology-linked and specialty injectable segments in the United States, a market where Indian companies remain major suppliers of affordable generic medicines.

Reference:
https://www.ibef.org/news/alembic-pharma-gets-usfda-nod-for-generic-cancer-arthritis-injection
https://alembicpharmaceuticals.com/webfiles/media/2026-2027/Press-Release-Methotrexate-Injection-USP.pdf
https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/alembic-pharma-gets-usfda-nod-for-generic-cancer-arthritis-injection/articleshow/130300734.cms
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=b585f621-f6c9-4735-ab61-bd1b401f3df0