Drug Approval

Zydus’ SEZ II, Ahmedabad plant clears USFDA inspection with nil observations

The inspection concluded with NIL observations

Zydus announced that the USFDA has completed a Pre-Approval Inspection (PAI) and general cGMP inspection at its formulation manufacturing plant in SEZ II, Ahmedabad. The inspection, conducted from 11 to 13 August 2025 for three products, concluded with no observations.

The inspection concluded with NIL observations.

Zydus
USFDA

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