Zydus Lifesciences Ltd on Friday said the United States Food and Drug Administration (US FDA) has completed an inspection at its injectable manufacturing plant in Jarod, near Vadodara, Gujarat.
The inspection, carried out between August 25 and September 5, 2025, ended with four observations. Importantly, the company noted that none of the findings were related to data integrity and that it will work closely with the regulator to address them at the earliest.
The update comes after a series of regulatory and business developments for the Ahmedabad-based drugmaker.
Just last month, Zydus said its Baddi formulation facility in Himachal Pradesh was inspected by the US FDA between August 4 and 13, which also concluded with four observations and no data integrity concerns.
Earlier this week, Zydus announced it had launched ‘VaxiFlu
’, a trivalent influenza vaccine aligned with World Health Organization guidelines, becoming the first Indian company to do so.
On Thursday, its subsidiary Zydus Lifesciences Global FZE signed an exclusive licensing and supply deal with Netherlands-based Synthon BV for Ozanimod capsules, the generic version of Zeposia, in the US market.
Also Read: US FDA wraps Aurobindo Pharma’s Bachupally plant inspection with 8 observations
Separately, Aurobindo Pharma also disclosed today that its Bachupally facility in Telangana was inspected by the US FDA over the same period, concluding with eight procedural observations.
Shares of Zydus Lifesciences closed at ₹1,015 on the NSE, up 0.30% or ₹3.05, ahead of the announcement.
