Lupin announced that with respect to the inspection undertaken by U.S. FDA at its Pithampur Unit-2 manufacturing facility from July 8 to July 17, 2025, wherein the inspection was closed with the issuance of a Form-483 with four observations, the U.S. FDA has determined the inspection classification of this facility as “Official Action Indicated (OAI)".
The Company is working with the U.S. FDA to satisfactorily resolve the compliance issues and is committed to be compliant with CGMP standards at all its manufacturing facilities.