USFDA issues 6 observations to Zydus' Gujarat API unit after inspection

Zydus Lifesciences on Saturday said the US health regulator has issued six observations after inspecting its Gujarat-based API manufacturing unit.

"We wish to inform that the US Food and Drug Administration (USFDA) conducted a surveillance inspection at the group's API (active pharmaceutical ingredient) unit located at Dabhasa in Gujarat," the drug firm said in a regulatory filing.

The inspection was conducted from April 21-25, 2025. "The inspection concluded with 6 observations and none of them were related to data integrity," Zydus Lifesciences said.

The company is confident of addressing the observations expeditiously, it added.