Medicamen Biotech Limited has informed the Exchange about General Updates- Intimation under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 - Approval of Abbreviated New Drug Application (ANDA)
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Medicamen Biotech has received its first-ever Abbreviated New Drug Application (ANDA) approval from the USFDA for Bortezomib for Injection 3.5 mg, a single-dose vial. The product is approved as a generic equivalent to Takeda's Velcade, which is used to treat multiple myeloma (a type of cancer). The drug's API was developed in-house and manufactured at Shivalik Rasayan, which holds an active USDMF. This is described as a major milestone marking the company's entry into regulated US markets, supported by vertically integrated manufacturing capabilities.
This is a positive development for shareholders as it opens up a large, lucrative US generic drug market for Medicamen and validates its in-house R&D and manufacturing capabilities. Future US sales of Bortezomib could contribute meaningfully to revenue and earnings, though the company is yet to disclose commercial launch timelines or expected revenue contribution.