Alembic Pharmaceuticals has achieved a significant regulatory milestone with the receipt of final approval from the US Food and Drug Administration (FDA) for Methotrexate Injection USP. The company announced this development through a regulatory filing under Regulation 30, marking an important addition to its portfolio of injectable medications in the US market.

Product Specifications and Approval Details

The FDA approval encompasses comprehensive coverage for Methotrexate Injection USP with specific dosage formulations:

The approved Abbreviated New Drug Application (ANDA) is therapeutically equivalent to the reference listed drug product of Hospira, Inc. This equivalence certification ensures that the generic version meets the same quality, safety, and efficacy standards as the original branded medication.

Therapeutic Applications and Indications

Methotrexate Injection serves as a folate analog metabolic inhibitor with extensive therapeutic applications across oncology and autoimmune conditions. The approved formulation is indicated for multiple neoplastic diseases including 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. Additionally, the injection is indicated for treating rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (pJIA), and severe psoriasis.

Regulatory Portfolio Expansion

This latest approval brings Alembic Pharmaceuticals' cumulative total to 236 ANDA approvals from the USFDA, comprising 218 final approvals and 18 tentative approvals. The company's growing regulatory portfolio demonstrates its commitment to expanding access to essential medications in the US market while maintaining compliance with stringent FDA standards.

Market Significance

The final approval status indicates successful completion of all regulatory requirements and clinical evaluations necessary for commercial distribution in the United States. The dual-format approval for both multi-dose and single-dose vials positions Alembic Pharmaceuticals to serve diverse healthcare settings and patient needs, strengthening its presence in the competitive US injectable drugs market.

Alembic Pharmaceuticals has announced the opening of a special window for shareholders to transfer and dematerialise their physical securities. The pharmaceutical company issued newspaper advertisements on 15th April, 2026, informing stakeholders about this important corporate development.

Special Window Details

The special window operates under SEBI Circular No. HO/38/13/11(2)2026-MIRSD-POD/1/3750/2026 dated 30th January, 2026. This initiative provides shareholders with an opportunity to convert their physical securities to dematerialised form.

Eligibility and Process

The special window covers securities that were sold or purchased before 1st April, 2019. Additionally, it accommodates transfer requests that were previously submitted but rejected, returned, or not processed due to document deficiencies or procedural issues.

Eligible investors must submit their transfer requests along with requisite documents to the company's Registrar and Transfer Agent. The securities transferred during this window period will be credited in demat form and will remain under lock-in for one year from the date of registration of transfer.

Registrar and Transfer Agent Information

Shareholders need to contact MUFG Intime India Private Limited for processing their requests. The RTA operates as the designated unit for Alembic Pharmaceuticals Limited.

Regulatory Compliance

The company has fulfilled its disclosure obligations under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The newspaper advertisements were published in Indian Express (English Edition) and Financial Express (Gujarati Edition) on 15th April, 2026.

Company Secretary Mahisha Saraf signed the regulatory communication to both BSE Limited and National Stock Exchange of India Ltd, ensuring compliance with stock exchange requirements. The company maintains its registered office at Alembic Road, Vadodara - 390 003.