Medicamen Biotech Receives First ANDA Approval from USFDA for Bortezomib for Injection 3.5 mg

Medicamen Biotech Ltd. has announced 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, which has been determined to be 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). The Bortezomib API has been developed in its own R&D and manufactured at Shivalik Rasayan having USDMF 036171. This approval marks a significant step forward in Medicamen’s commitment to enter regulated markets and demonstrates its capabilities to successfully develop and commercialize products using in-house R&D capabilities and its own API facility. The company remains committed to maintaining the integrity of its products and systems as it expands its footprint in the U.S. market.