Zydus Lifesciences Faces USFDA Scrutiny: Gujarat Plant Under Review

Zydus Lifesciences' API manufacturing unit in Gujarat has drawn six USFDA observations. A recent inspection by the US health regulator from April 21-25, 2025, concluded with these findings, none involving data integrity. The company is optimistic about addressing the issues promptly.

Zydus Lifesciences, a notable player in the pharmaceutical industry, recently encountered six regulatory observations from the US Food and Drug Administration (USFDA) following an inspection of its active pharmaceutical ingredient (API) manufacturing facility in Gujarat.

The inspection, which took place from April 21-25, 2025, scrutinized the operations at the Dabhasa-based unit and resulted in the observations, though none were related to data integrity, according to a statement by the company.

Zydus Lifesciences expressed confidence in its ability to address these observations swiftly and noted that it would take necessary actions to resolve any issues highlighted by the regulatory body.

(With inputs from agencies.)