Zydus Lifesciences' Gujarat Plant Receives 'Official Action Indicated' Notice From USFDA
The USFDA has determined that the inspection classification of the injectables manufacturing facility in Gujarat is 'Official Action Indicated'.
Zydus Lifesciences Ltd. said on Thursday that the US health regulator, after an inspection, has cautioned that its Gujarat-based injectables plant may be subject to regulatory action.
The pharmaceutical company received a report from the US Food and Drug Administration for the inspection conducted at its facility between April 15 and April 23, 2024, an exchange filing stated.
The USFDA has determined that the inspection classification of the injectables manufacturing facility located at Jarod, near Vadodara, Gujarat, is 'Official Action Indicated'. This means that the USFDA found objectionable conditions and the regulator can take regulatory administrative sanctions.
The company has said that it will work with the regulatory body to resolve the regulatory status of its facility.
Zydus Lifesciences said on Wednesday that it has inked a licensing pact with Takeda to market a drug for the treatment of gastroesophageal reflux disease. The drug will be marketed under the brand name Vault in the country, it added.
The shares of Zydus Lifesciences closed 0.07% higher on Thursday. That compares to a 0.76% advance in the NSE Nifty 50 Index.
