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