- Final ANDA clearance strengthens oncology and immunology portfolio in US market
- Approval for multi-dose and single-dose vials of critical cancer therapy drug
- Milestone takes total USFDA ANDA approvals to 236, reinforcing global footprint
NE BUSINESS BUREAU
MUMBAI, APR 16
Alembic Pharmaceuticals Limited on Thursday announced that it has received final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Methotrexate Injection USP.
The approval covers 50 mg/2 mL (25 mg/mL) multi-dose vials and 1g/40 mL (25 mg/mL) single-dose vials, marking a significant addition to the company’s specialty and oncology-focused portfolio in the United States.
The company stated, “We have received final approval from the USFDA for our ANDA Methotrexate Injection USP, reinforcing our commitment to expanding our injectable portfolio in regulated markets.”
The approved product is therapeutically equivalent to the reference listed drug (RLD) of Hospira, Inc., ensuring the same safety, efficacy and quality standards.
Methotrexate Injection, a folate analog metabolic inhibitor, is widely used in the treatment of multiple neoplastic diseases, including acute lymphoblastic leukemia, non-Hodgkin lymphoma, osteosarcoma, breast cancer, and head and neck cancers. It is also prescribed for autoimmune conditions such as rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and severe psoriasis.
Industry experts note that such approvals not only enhance access to critical therapies but also position Indian pharma players as key contributors in the global generics ecosystem.
With this latest nod, Alembic’s cumulative tally has reached 236 ANDA approvals from the USFDA, comprising 218 final approvals and 18 tentative approvals—a testament to its sustained regulatory and manufacturing strength.
