USFDA Raises Six Observations After Inspecting Zydus’ Gujarat API Unit

The U.S. Food and Drug Administration (USFDA) recently conducted an inspection at Zydus Lifesciences’ active pharmaceutical ingredient (API) manufacturing facility in Dabhasa,

Gujarat, from April 21 to 25, 2025. Following the inspection, the USFDA issued six observations, though none were related to data integrity concerns.

Zydus Lifesciences has stated that it is confident in addressing these observations promptly. The company has not yet disclosed the specific details of the observations but is committed to resolving them in compliance with regulatory guidelines. This incident underscores the continued regulatory scrutiny of pharmaceutical manufacturing units to ensure they meet global quality standards.