Medicamen Biotech Limited announced on June 3, 2025, that it has received its first Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (USFDA) for Bortezomib for Injection, 3.5 mg single-dose vial. This marks a critical milestone in the company’s journey to expand into regulated markets, particularly the United States.
The product is found to be bioequivalent and therapeutically equivalent to Velcade for Injection, a drug marketed by Takeda Pharmaceuticals U.S.A., Inc. The API (Active Pharmaceutical Ingredient) for the product was developed in-house and manufactured at Shivalik Rasayan, which holds a valid USDMF (Drug Master File No. 036171).
The approval strengthens Medicamen Biotech’s vertically integrated product portfolio and is a testament to its robust R&D capabilities and commitment to regulatory compliance and cGMP standards. The company emphasized that this achievement reflects its growing focus on global markets and quality-driven manufacturing.
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