Regulatory Inspection Summary
Zydus Lifesciences Limited disclosed that the US Food and Drug Administration (USFDA) conducted a current Good Manufacturing Practices (cGMP) inspection at the company's manufacturing facility located at SEZ II, Ahmedabad.
Inspection Details
- Inspection Period: September 21 to September 28, 2026
- Facility Location: SEZ II, Ahmedabad, India
- Inspection Type: USFDA cGMP compliance inspection
Inspection Outcome
- The inspection concluded with one observation issued by USFDA
- No data integrity related observations were identified during the inspection
- The Company stated it will closely work with the USFDA to address the observation expeditiously