Lupin Gets Green Flag From USFDA For Its Pithampur Unit-2 Facility
Global pharma major Lupin on Tuesday said in an exchange filing that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U.S. FDA) for its Pithampur Unit-2 manufacturing facility that manufactures oral solids and ophthalmic dosage forms.
The EIR was issued post the last inspection of the facility conducted from March 21 to March 29, 2023. The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI).
As per the FDA, Voluntary Action Indicated means objectionable conditions were found and documented but the agency is not prepared to take or recommend regulatory action.
“We are pleased to have received the EIR from the US FDA with a satisfactory VAI status for our Pithampur Unit-2 facility. This is a significant milestone as we build back our reputation of being best-in-class in Quality and Compliance. We look forward to new products approvals and launches, especially ophthalmic products from this facility now,” said Nilesh Gupta, Managing Director, Lupin.
The company's shares closed 1.35 per cent higher on Tuesday at Rs 912.90 per scrip on BSE.
