Medicamen Biotech rallies after securing USFDA approval for Bortezomib injection
Medicamen Biotech soared 5.39% to Rs 440 after the company 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 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 companys strategy to enter regulated markets. The Bortezomib API was developed in-house through the companys R&D efforts and manufactured at Shivalik Rasayan, which holds USDMF 036171.
The achievement underscores Medicamens 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 companys 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 companys 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.
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