Alembic Pharma shares gain after drugmaker gets USFDA approval for cancer treatment drug

Alembic Pharmaceuticals Ltd. on Thursday, April 16, said it has received final approval from the US Food and Drug Administration (USFDA) for its generic version of Methotrexate Injection. The stock gained in response to the news.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.