4 days ago
Medicamen Biotech secures USFDA nod for Bortezomib injection, marks its first ANDA approval
By Aditya Bhagchandani Published on June 3, 2025, 12:56 IST
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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Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.
