Alembic Pharma gets USFDA nod for generic cancer, arthritis injection
- IBEF
- April 17, 2026
Alembic Pharmaceuticals Limited has received final approval from the US Food and Drug Administration (USFDA) for its generic methotrexate injection, marking a significant addition to its oncology and speciality portfolio. The approval is for the abbreviated new drug application (ANDA) covering key dosage strengths, including 50 mg/2 ml multi-dose vials and 1g/40 ml single-dose vials. The product has been considered therapeutically equivalent to the reference listed drug by Hospira, enabling the company to market the injectable in the United States, one of the world’s largest pharmaceutical markets.
Methotrexate injection is widely prescribed for the treatment of multiple cancers such as acute lymphoblastic leukaemia, osteosarcoma and breast cancer, along with autoimmune conditions like rheumatoid arthritis, juvenile idiopathic arthritis and severe psoriasis. The approval strengthens the company’s presence in the regulated US generics segment and supports its strategy of expanding complex injectable offerings. With consistent regulatory clearances, the company continues to enhance its product pipeline and global footprint, particularly in high-value therapeutic areas such as oncology.
Disclaimer: This information has been collected through secondary research and IBEF is not responsible for any errors in the same.
Partners
