The approved ANDA is therapeutically equivalent to the reference listed drug, Methotrexate Injection USP, manufactured by Hospira Inc.
With this approval, Alembic Pharmaceuticals now has a cumulative total of 236 ANDA approvals from the USFDA, including 218 final and 18 tentative approvals.
Alembic Pharmaceuticals, a vertically integrated research and development company, is engaged in the manufacture and marketing of generic pharmaceutical products across global markets. The company’s consolidated net profit fell 3.9% to Rs 132.97 crore despite a 10.8% jump in net sales to Rs 1,876.31 crore in Q3 FY26 over Q3 FY25.
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