With reference to intimation dated July 17, 2025 and with respect to the inspection undertaken by US FDA at 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, Lupin has informed that US FDA has determined the inspection classification of this facility as ‘Official Action Indicated (OAI)’. The Company is working with the US FDA to satisfactorily resolve the compliance issues and is committed to be compliant with CGMP standards at all its manufacturing facilities.
The above information is a part of company’s filings submitted to BSE.
