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 years. It also highlights the company’s strong commitment to stringent quality standards, robust regulatory compliance, and adherence to Current Good Manufacturing Practices (cGMP).
Medicamen reaffirmed its dedication to maintaining the integrity of its products and systems as it continues to expand its footprint in the U.S. market.
Medicamen Biotech is a research-led pharmaceutical company involved in developing, manufacturing, and marketing generic finished dosage formulations, and Oncology Formulations.
The company’s consolidated net profit rose 13.6% to Rs 2.42 crore in Q4 FY25, despite a 37.4% decline in revenue from operations to Rs 29.61 crore compared to the year-ago period.