Marksans Pharma Limited has informed the Exchange regarding a press release dated November 10, 2025, titled " US FDA cGMP inspection at Company s 2nd manufacturing facility located at Plot No. A-1, Phase 1-A, Verna Industrial Estate, Verna, Goa, India concluded with zero Form 483 observation.".
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Marksans Pharma's second manufacturing facility at Verna Industrial Estate, Goa, has cleared a US FDA cGMP (current Good Manufacturing Practice) inspection with zero Form 483 observations. A Form 483 is issued when the FDA finds objectionable conditions during an inspection, so receiving none means the regulator found no significant compliance issues. This is the company's 2nd manufacturing facility, suggesting it is part of their capacity expansion strategy. The clean inspection outcome supports uninterrupted production and exports to the lucrative US market.
This is positive news for shareholders — a clean US FDA inspection removes a key regulatory risk and supports continued US supply approvals. The stock may see positive sentiment as it strengthens the company's credibility with global clients.