The oncology injectable manufacturing of Zydus in SEZ1, Ahmedabad, has received two observations from the U.S. Food and Drug Administration (U.S. FDA).
The pre-approval inspection at the oncology injectable manufacturing, in relation to the new isolator injectable line, by the U.S. FDA, from November 4-13, concluded with two observations, Zydus Lifesciences said in a filing on Thursday.
The company said there were no data integrity related observations and it will closely work with the regulator to address the observations expeditiously.
Published – November 13, 2025 11:06 pm IST
Source: https://www.thehindu.com/business/oncology-injectable-facility-of-zydus-gets-two-us-fda-observations/article70276034.ece
