Alembic Pharmaceuticals has received final approval from the United States Food and Drug Administration for its Methotrexate Injection, strengthening its presence in the regulated US market. The company disclosed the development in a regulatory filing dated Thursday, April 16.
The approval covers Methotrexate Injection USP in both 50 mg per 2 mL multi dose vials and 1g per 40 mL single dose vials. The product is therapeutically equivalent to the reference listed drug of Hospira and is used in the treatment of multiple conditions, including various cancers such as acute lymphoblastic leukemia, non Hodgkin lymphoma, osteosarcoma, and breast cancer, along with autoimmune conditions like rheumatoid arthritis and severe psoriasis.
This approval has been granted under the abbreviated new drug application pathway, allowing Alembic to market a generic version of the drug in the United States. The company continues to expand its portfolio of complex generics and injectables, which remain a key focus area in its international business strategy.
With this latest approval, Alembic now has a cumulative total of 236 ANDA approvals from the USFDA, including 218 final approvals and 18 tentative approvals. This milestone highlights the company’s sustained progress in building a diversified pipeline for regulated markets.
Alembic Pharmaceuticals, headquartered in India, operates as a vertically integrated research and development driven pharmaceutical company with a global footprint. Its manufacturing facilities are approved by several international regulatory authorities, including the USFDA, supporting its continued expansion in developed markets.