Alembic Pharma Wins USFDA Nod for Methotrexate Injection in Key U.S. Generics Boost

Alembic Pharmaceuticals Limited ( (IN:APLLTD) ) just unveiled an announcement.

Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration for its Methotrexate Injection USP in 50 mg/2 mL multi-dose vials and 1 g/40 mL single-dose vials, which are therapeutically equivalent to Hospira Inc.’s reference product. The drug, a folate analog metabolic inhibitor, is indicated for multiple neoplastic diseases as well as rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and severe psoriasis, and this approval raises Alembic’s cumulative USFDA ANDA approvals to 236, reinforcing its position in the U.S. generics market.

The latest approval further strengthens Alembic’s oncology and autoimmune disease portfolio in the United States, expanding its injectable offerings in a complex and highly regulated segment. By adding another USFDA-cleared product to its pipeline, the company enhances its competitive stance among global generic manufacturers and underscores the ongoing commercialization potential of its investment in US-focused research and manufacturing capabilities.

More about Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals Limited is a vertically integrated research and development-driven pharmaceutical company headquartered in India. It manufactures and markets generic pharmaceutical products globally, operates USFDA-approved research and manufacturing facilities, and is a leader in branded generics in the Indian market, supported by a field force of over 5,500 representatives.

Average Trading Volume: 3,768

Technical Sentiment Signal: Sell

Current Market Cap: 141.4B INR

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