Zydus Lifesciences receives 6 observations from USFDA for Gujarat API unit

Kaumi GazetteScience26 April, 20258.2K Views

Zydus Lifesciences receives 6 observations from USFDA for Gujarat API unit

Zydus Lifesciences on Saturday stated it obtained six observations from the US Food and Drug Administration (USFDA) following a surveillance inspection of its energetic pharmaceutical ingredient (API) manufacturing facility in Dabhasa, Gujarat.
In a regulatory submitting, the corporate said that the inspection was performed between April 21 and April 25, 2025.
“We wish to inform that the USFDA conducted a surveillance inspection at the group’s API Unit, located at Dabhasa in Gujarat. The inspection was conducted from April 21st to 25th, 2025. The inspection concluded with 6 observations and none of them were related to Data Integrity, ” Zydus Lifesciences stated in a regulatory submitting to NSE.
The firm added that it’s assured of addressing the observations in a well timed method.
On Friday, shares of Zydus Lifesciences ended decrease on the National Stock Exchange. The inventory declined by 2.45% to shut at Rs 859.65, down Rs 21.55 from its earlier shut of Rs 880.25. It opened at Rs 879.65 and moved between an intraday excessive of Rs 882.35 and a low of Rs 858.00.

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