Oncology injectable facility of Zydus gets two U.S. FDA observations

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The oncology injectable manufacturing of Zydus successful SEZ1, Ahmedabad, has received 2 observations from the U.S. Food and Drug Administration (U.S. FDA).

The pre-approval inspection astatine the oncology injectable manufacturing, successful narration to the caller isolator injectable line, by the U.S. FDA, from November 4-13, concluded with 2 observations, Zydus Lifesciences said successful a filing connected Thursday.

The institution said determination were nary information integrity related observations and it volition intimately enactment with the regulator to code the observations expeditiously.

Published - November 13, 2025 11:06 p.m. IST

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