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Zydus Life Vadodara Unit Receives 4 USFDA Observations

Zydus Lifesciences
The tablets will be made at Zydus Lifesciences’ formulation facility in Ahmedabad SEZ.

Shares of Zydus Lifesciences Ltd were trading in the green and almost 1% higher on 8 September despite the company’s Vadodara unit receiving 4 observations from the USFDA. 

The US Food and Drug Administration (USFDA) performed an inspection of the group’s injectable manufacturing factory in Jarod, near Vadodara, Gujarat, from 25 August to 5 September 2025. The US agency issued four observations following the completion of the inspection, the business stated.

There were no data integrity observations, and the company would work closely with the USFDA to address the observations as soon as possible, it added.

Last week, the company’s wholly owned subsidiary, Zydus Lifesciences Global FZE, signed an exclusive licensing and supply deal with Synthon BV of the Netherlands for Ozanimod Capsules (a generic form of ZEPOSIA) for the US market.

Synthon has a pending abbreviated new drug application in the United States for Ozanimod Capsules, which are intended for relapsing forms of multiple sclerosis.

The company also announced the launch of its trivalent influenza (Flu) vaccine VaxiFluTM, which was launched for the first time in India in accordance with the WHO’s global recommendations.

At 12:15 pm, the shares of Zydus Life were trading 0.47% higher at Rs 1,018.65 on NSE.

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