Zydus Lifesciences Ltd on Saturday mentioned the US well being regulator has issued six observations after inspecting its Gujarat-based API manufacturing unit.
“We want to inform that the US Meals and Drug Administration (USFDA) carried out a surveillance inspection on the group’s API (energetic pharmaceutical ingredient) unit positioned at Dabhasa in Gujarat,” the drug agency mentioned in a regulatory submitting.
The inspection was carried out from April 21-25, 2025.
“The inspection concluded with 6 observations and none of them had been associated to information integrity,” Zydus Lifesciences mentioned.
The corporate is assured of addressing the observations expeditiously, it added.
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