USFDA Approval
USFDA Final Approval for Methotrexate Injection
Alembic received USFDA final approval (16 Apr 2026) for Methotrexate Injection USP 50 mg/2 mL multi-dose and 1 g/40 mL single-dose vials; the ANDA is therapeutically equivalent to Hospira's RLD and lifts Alembic's cumulative ANDAs to 236.




