Zota Health Care LImited has informed the Exchange regarding 'Receipt of Inspection Report of European Union Good Manufacturing Practice (EU GMP) Audit conducted for the manufacturing unit situated at Surat Special Economic Zone'.
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Zota Health Care informed the exchange about the outcome of the European Union Good Manufacturing Practice (EU GMP) audit conducted at its Surat Special Economic Zone manufacturing plant from May 6 to May 9, 2025. The audit concluded with zero critical observations, 16 major observations, and 8 other observations. The company will submit a corrective action plan within 20 days and provide detailed responses with evidence within 30 days (for major) and 60 days (for other observations). Exports to European countries will only begin after satisfactory resolution of all observations and receipt of EU GMP approval.
The EU GMP approval is still pending and dependent on resolving 24 observations, so there is no immediate revenue impact. Investors should watch for the corrective action submissions and the final EU GMP approval, which would unlock a new export market and potentially boost future revenue.