Zydus Lifesciences has announced that its formulations manufacturing plant at SEZ-II in Ahmedabad has successfully cleared a United States Food and Drug Administration (US FDA) Pre-Approval Inspection (PAI) with zero observations.

The inspection, which took place from 11 to 13 August 2025, evaluated three products under general current Good Manufacturing Practice (cGMP) standards and concluded without any regulatory findings or compliance issues.

A Pre-Approval Inspection is conducted by the US FDA to verify that a drug manufacturing facility can reliably produce pharmaceuticals and that the data submitted in support of regulatory applications are accurate and complete. Achieving a clean inspection outcome underscores Zydus’s robust quality control systems and strengthens its regulatory credibility—particularly for future drug approvals and market access initiatives.