Zydus gets 6 observations from USFDA for API unit

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.