Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Methotrexate Injection USP, 50 mg/2 mL (25 mg/mL) Multi-Dose Vials & 1g/40 mL (25 mg/mL) SingleDose Vials.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Methotrexate Injection USP, 50 mg/2 mL (25 mg/mL) Multi- Dose Vials & 1g/40 mL (25 mg/mL) SingleDose Vials, of Hospira, Inc. Methotrexate Injection is a folate analog metabolic inhibitor indicated for neoplastic diseases: Acute Lymphoblastic Leukemia, Meningeal Leukemia: Prophylaxis and Treatment, Non-Hodgkin Lymphoma, Osteosarcoma, Breast Cancer, Squamous Cell Carcinoma of the Head and Neck, and Gestational Trophoblastic Neoplasia. It is also indicated for the treatment of: rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (pJIA), and severe psoriasis. Refer label for a detailed indication.
Alembic has a cumulative total of 236 ANDA approvals (218 final approvals and 18 tentative approvals) from USFDA.
Alembic Pharmaceuticals is involved in manufacturing and marketing of India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities
