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)

Regulatory Product ApprovalBusiness Updates View source PDF Explain this filing

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Price reactionminutes from the announcement price · days from the prior close

+4.1%Reaction day

₹417.85

prior close

₹429.50

announcement price

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Nifty Microcap 250market · in no size index; the smallest one is used-0.3%+4.4% vs market

Pharmaceuticals peers, median of 147sector-0.2%+4.3% vs sector

On the reaction day the stock moved 4.4 pts more than Nifty Microcap 250 and 4.3 pts more than its Pharmaceuticals peers, over the same two closes: a difference in percentage points, not a measure of what the filing did.

Minutes after the announcementfrom the announcement price · no benchmark

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Reaction day

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Next day

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UpDownMarket · Nifty Microcap 250Sector · Pharmaceuticals peers, median of 147Pending

Minute windows have no benchmark: there is no intraday index history to compare against.

AI summary

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.

Likely market impact

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.