Alembic Pharmaceuticals Limited announced on April 16, 2026, that it secured final approval from the U.S. Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) covering Methotrexate Injection USP.
The approved product addresses two formulations: Multi-Dose Vials of 50 mg/2 mL (25 mg/mL) and Single-Dose Vials of 1g/40 mL (25 mg/mL). This approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Methotrexate Injection USP, manufactured by Hospira, Inc.
Methotrexate Injection is a folate analog metabolic inhibitor used in the treatment and prophylaxis of several conditions. Its indicated uses include neoplastic diseases, such as Acute Lymphoblastic Leukemia, Meningeal Leukemia, Non-Hodgkin Lymphoma, Osteosarcoma, Breast Cancer, Squamous Cell Carcinoma of the Head and Neck, and Gestational Trophoblastic Neoplasia. Additionally, the drug is indicated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (pJIA), and severe psoriasis.
In addition to this milestone, Alembic Pharmaceuticals reported achieving a cumulative total of 236 ANDA approvals from the USFDA. This includes 218 final approvals and 18 tentative approvals.
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company with a history dating back to 1907. Headquartered in India, the company manufactures and markets generic pharmaceutical products worldwide. Alembic's state-of-the-art research and manufacturing facilities hold approvals from regulatory authorities in several developed nations, including the USFDA. The company is noted as one of the leaders in branded generics in India.
APLLTD Stock Price Movement
Shares of Alembic Pharmaceuticals Limited are edging higher to ₹747.7 as of 11:19 AM, gaining 1.76% or ₹12.90 in live trading. The stock is seeing substantial intraday activity, underpinned by a volume of 34,628 shares.Source:
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