USFDA Classifies Zydus Plant as 'Official Action Indicated'
Jul 18, 2024 18:44
USFDA has issued an 'Official Action Indicated' classification for Zydus Lifesciences's injectables plant in Gujarat, indicating potential regulatory action.
Photograph: Courtesy Zydus.
New Delhi, Jul 18 (PTI) Zydus Lifesciences on Thursday said the US health regulator has cautioned that its Gujarat-based injectables plant may be subject to regulatory actions.
The company said it has received a report from the US Food and Drug Administration (USFDA) for the inspection conducted at its injectables manufacturing facility located at Jarod, near Vadodara, Gujarat between April 15-23, 2024.
The USFDA has determined that the inspection classification of this facility is Official Action Indicated (OAI), it added.
According to FDA, OAI means "objectionable conditions were found and regulatory administrative sanctions by FDA are indicated" during the inspection.
"The company will work closely with the agency to resolve the regulatory status of this facility expeditiously," the drug maker said.
Shares of Zydus Lifesciences settled marginally up at Rs 1,185.30 apiece on the BSE.
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