Zydus Lifesciences receives 6 observations from USFDA for Gujarat API unit

Zydus Lifesciences on Saturday said it received six observations from the US Food and Drug Administration (USFDA) following a surveillance inspection of its active pharmaceutical ingredient (API) manufacturing facility in Dabhasa, Gujarat.
In a regulatory filing, the company stated that the inspection was conducted 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 said in a regulatory filing to NSE.
The company added that it is confident of addressing the observations in a timely manner.
On Friday, shares of Zydus Lifesciences ended lower on the National Stock Exchange. The stock declined by 2.45% to close at Rs 859.65, down Rs 21.55 from its previous close of Rs 880.25. It opened at Rs 879.65 and moved between an intraday high of Rs 882.35 and a low of Rs 858.00.