By: IPP Bureau
Last updated : August 18, 2022 11:38 am
The OAI classification implies that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
Sun Pharmaceutical Industries Limited has received a communication from the USFDA indicating the inspection classification of Halol at Gujarat facility as "Official Action Indicated" (OAI).
The OAI classification implies that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved. The Company continues to manufacture and distribute the existing products for the US market, thereby not likely to have any material adverse impact on current business from the Halol facility.
"Sun Pharma has been continuously cooperating with the USFDA and will undertake all necessary steps to resolve these issues. It ensures that the regulator is completely satisfied with the Company's remedial action", Sun pharma said.