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

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.