Business Update22 Oct 2026, 01:03 pm
Kopran Ltd: EU GMP Inspection at Khopoli Facility Concluded Successfully
AI Summary
Kopran Limited announced the successful conclusion of a Good Manufacturing Practices (GMP) inspection conducted by the European Union's Medicine Authority at its formulation manufacturing facility in Khopoli. The inspection, held from September 18-23, 2026, resulted in no critical observations, one major observation, and some minor observations. Importantly, there were no data integrity-related observations. The company is preparing to submit its compliance responses to the EU authorities within the next fortnight.
Key Highlights
- EU Medicine Authority GMP inspection at Khopoli facility successfully concluded.
- No critical observations were noted during the inspection.
- One major and several minor observations were reported.
- No data integrity issues were identified.
- Compliance responses to be submitted within two weeks.
Price Impact
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