Global pharma major Lupin Limited (Lupin) on Tuesday announced 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, through an exchange filing. 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).
“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 bestin-class in Quality and Compliance. We look forward to new product approvals and launches, especially ophthalmic products from this facility now,” said Nilesh Gupta, Managing Director, Lupin.
The share of Lupin on Tuesday closed at Rs 917.85, up by 1.89 per cent.