💡 USFDA final approval for Methotrexate Injection opens new revenue stream in US generic market.
What Happened
Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Methotrexate Injection USP. The approval covers two dosage forms: 50 mg/2 mL Multi-Dose Vials and 1g/40 mL Single-Dose Vials. This product is therapeutically equivalent to the reference listed drug from Hospira, Inc.
Key Details
- Company: Alembic Pharmaceuticals Limited
- Event Type: Regulatory
- Filing Date: 16-Apr-2026 11:17:06
- NSE Filing: View Document
Why It Matters
This USFDA approval represents a significant regulatory milestone for Alembic Pharmaceuticals, allowing the company to launch a new generic oncology product in the lucrative US market. Methotrexate Injection is used to treat various cancers including leukemia, lymphoma, and breast cancer, as well as rheumatoid arthritis and severe psoriasis. The approval adds to Alembic's growing portfolio of 236 ANDA approvals (218 final and 18 tentative) and demonstrates the company's continued regulatory success with USFDA. This expansion of their US generic product lineup could contribute to future revenue growth from the company's international business segment.
Disclaimer: This is publicly available information sourced from NSE. Not investment advice.
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