Zydus Lifesciences Under FDA Scrutiny for Gujarat Injectables Plant

Zydus Lifesciences' injectables plant in Gujarat is under scrutiny from the USFDA, with a classification of Official Action Indicated, implying regulatory actions. The company aims to address the regulatory concerns swiftly. Shares of Zydus Lifesciences saw a slight increase on the BSE, closing at Rs 1,185.30.

Zydus Lifesciences is facing regulatory scrutiny from the US Food and Drug Administration (USFDA) concerning its injectables manufacturing facility in Jarod, near Vadodara, Gujarat. The plant has received an Official Action Indicated (OAI) status from the USFDA, which signals that objectionable conditions were found during an inspection conducted between April 15-23, 2024.

Zydus Lifesciences stated they are committed to cooperating closely with the USFDA to resolve the regulatory status of this facility promptly. The inspection results come as a significant development for the company, which has pledged to address the noted deficiencies.

Despite the potential regulatory challenges, shares of Zydus Lifesciences settled slightly higher, closing at Rs 1,185.30 per share on the Bombay Stock Exchange (BSE).

(With inputs from agencies.)