US FDA Completes Inspection at Zydus Vadodara Facility with Four Observations

8 Sep 2025 , 09:36 AM

Zydus Lifesciences Ltd on Friday said the US Food and Drug Administration (US FDA) has completed an inspection at its injectable manufacturing plant in Jarod, near Vadodara, Gujarat.

The inspection, conducted between August 25 and September 5, 2025, concluded with four observations. The company clarified that none of the findings were linked to data integrity, and it will work closely with the regulator to resolve the issues at the earliest.

This development follows a series of regulatory updates for the Ahmedabad-based drugmaker:

• In August, the US FDA inspected its Baddi formulation facility in Himachal Pradesh (August 4–13), which also ended with four observations without data integrity concerns.
• Earlier this week, Zydus launched ‘VaxiFlu’, a trivalent influenza vaccine aligned with WHO guidelines, becoming the first Indian company to introduce such a vaccine.

On Thursday, its subsidiary Zydus Lifesciences Global FZE entered into an exclusive licensing and supply agreement with Netherlands-based Synthon BV for Ozanimod capsules (generic version of Zeposia) in the US market.

In a related industry development, Aurobindo Pharma disclosed that the US FDA inspected its Bachupally facility in Telangana over the same period, with the audit concluding in eight procedural observations.

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