Mumbai, June 3 -- The ANDA pertains to Bortezomib for Injection, 3.5 mg single-dose vial. The USFDA has determined that the product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Velcade for Injection, 3.5 mg/vial, marketed by Takeda Pharmaceuticals U.S.A. Inc. (NDA-021602).

This milestone marks a significant step forward in the company's strategy to enter regulated markets. The Bortezomib API was developed in-house through the company's R&D efforts and manufactured at Shivalik Rasayan, which holds USDMF 036171.

The achievement underscores Medicamen's capabilities in successfully developing and commercializing products using its own R&D and API manufacturing infrastructure, built over the past few ye...