Alembic Pharma and Aurobindo Pharma receive USFDA ANDA approvals for Methotrexate Injection and Dextromethorphan suspension, strengthening their US generics presence.
Written By: Sana Khan, BPharm and Vennela Reddy, BPharm
Reviewed By: Pharmacally Editorial Team
India’s pharmaceutical sector continues to strengthen its presence in the U.S. generics market, with Alembic Pharmaceuticals Limited and Aurobindo Pharma Limited announcing fresh approvals from the U.S. Food and Drug Administration (USFDA).
Alembic Pharmaceuticals: Methotrexate Injection Approval
Alembic Pharmaceuticals has received final approval for its Abbreviated New Drug Application (ANDA) for Methotrexate Injection USP, available in 50 mg/2 mL (25 mg/mL) multi-dose vials and 1 g/40 mL (25 mg/mL) single-dose vials.
The product is therapeutically equivalent to the reference listed drug (RLD) from Hospira, Inc. Methotrexate treats several cancers, including acute lymphoblastic leukemia, non-Hodgkin lymphoma, osteosarcoma, breast cancer, and head and neck cancers. It is also indicated for autoimmune conditions such as rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and severe psoriasis.
This approval expands Alembic’s oncology and specialty portfolio in the U.S. The company now holds a cumulative total of 236 ANDA approvals from the USFDA, comprising 218 final approvals and 18 tentative approvals.
Aurobindo Pharma: Dextromethorphan Oral Suspension Approval
Aurobindo Pharma has secured USFDA approval for Dextromethorphan Polistirex Extended-Release Oral Suspension, 30 mg/5 mL (OTC).
The product is bioequivalent to Delsym Extended-Release Oral Suspension from RB Health (US) LLC. It provides temporary relief of cough due to minor throat and bronchial irritation, while suppressing the urge to cough to aid sleep.
Manufactured at Unit-IV of APL Healthcare Limited—a wholly owned subsidiary—the product is slated for launch in Q2 FY27. Nielsen estimates peg the U.S. market size at approximately $138 million for the 12 months ending February 2026.
With this approval, Aurobindo Pharma’s total ANDA approvals reach 580, including 557 final approvals and 23 tentative approvals.
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About the Writer
Sana Jamil Khan is a B.Pharm graduate with a strong interest in medical writing and scientific communication. Her work focuses on interpreting clinical research, exploring developments in pharmaceutical science, and presenting complex medical information in a clear and accessible manner. She is particularly interested in topics related to human clinical studies, drug safety observations, and emerging therapeutic research.
About the Writer
Vennela Reddy, B.Pharm is a pharmacy graduate with a keen interest in clinical research, pharmacovigilance, and medical writing, with a growing focus on publishable and scientific content development. In her words, she is passionate about translating complex medical data into clear, evidence-based communication.
