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  • Zydus Lifesciences'...

Zydus Lifesciences' Moraiya Plant Receives 5 USFDA Observations

Written By : Parthika Patel Published On 2026-10-15T17:25:37+05:30  |  Updated On 15 Oct 2026 5:25 PM IST
Zydus Lifesciences Moraiya Plant Receives 5 USFDA Observations
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Ahmedabad: The US Food and Drug Administration (USFDA) has concluded an inspection of Zydus Lifesciences Limited's manufacturing plant at Moraiya in Ahmedabad, Gujarat, with five observations.

The inspection was conducted from October 5 to October 13, 2026, according to a press release issued by the pharmaceutical company on October 13, 2026.

Zydus Lifesciences informed the stock exchanges about the completion of the inspection through a regulatory filing dated October 13, 2026. The company stated that the inspection of its manufacturing facility at Moraiya concluded with five observations.

Following the inspection, Zydus Lifesciences said it would work closely with the USFDA to address the observations expeditiously. The company did not provide further details regarding the individual observations in its press release.

Also Read: Zydus, Formycon Hit Major USFDA Milestone for First USD 31 Billion Keytruda Biosimilar

Zydus Lifesciences Limited, the USFDA inspection at the Moraiya manufacturing plant was conducted over eight calendar days, from October 5 to October 13, 2026. The company stated that it would work with the US regulatory authority to address the five observations promptly.

Also Read: Zydus Wellness Expands Global Footprint with New Ireland, UAE Subsidiaries

zydus lifescienceszydus moraiya plantzydus ahmedabadusfdainspection
Parthika Patel
Parthika Patel

    M. Pharm (Pharmaceutics)

    Parthika Patel has completed her Graduated B.Pharm from SSR COLLEGE OF PHARMACY and done M.Pharm in Pharmaceutics. She can be contacted at editorial@medicaldialogues.in. Contact no. 011-43720751

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