Medicamen Biotech 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. The ANDA is for Bortezomib for Injection, 3.5 mg Single-Dose Vial. The FDA has determined that Bortezomib for Injection, 3.5 mg Single-Dose Vial, is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Velcade for Injection, 3.5 mg/vial, of Takeda Pharmaceuticals U.S.A. Inc. (NDA-021602).
This achievement marks a major step forward in its commitment to enter in regulated markets. The Bortezomib API has been developed in its own R&D and API has been manufactured at Shivalik Rasayan having USDMF 036171, It is a testament to its capabilities to successfully develop and commercialize products using in house R&D capabilities and own API facility, built over last few years.it also demonstrate the company’s dedication to stringent quality standards, robust regulatory compliance, and adherence to Current Good Manufacturing Practices (cGMP).
Medicamen Biotech is engaged in manufacturing and marketing of pharmaceutical formulations in overseas and domestic markets.
