The approval covers Methotrexate Injection USP, 50 mg/2 mL (multi-dose vials) and 1g/40 mL (single-dose vials), the company said in a filing to exchanges.
The approved product is therapeutically equivalent to the reference listed drug of Hospira Inc.
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Methotrexate Injection is used in the treatment of multiple conditions, including various cancers such as acute lymphoblastic leukaemia, non-Hodgkin lymphoma, osteosarcoma and breast cancer, as well as autoimmune diseases like rheumatoid arthritis, juvenile idiopathic arthritis and severe psoriasis.
With this approval, Alembic Pharma now has a cumulative total of 236 ANDA approvals from the USFDA, including 218 final approvals and 18 tentative approvals.
The development strengthens the company’s presence in the US generics market, which remains a key growth driver for Indian pharmaceutical companies.
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Shares of Alembic Pharma are trading 1.8% higher on Thursday at ₹747.7. The stock has risen 10.6% so far in the last one month.
