Lupin gets EIR from US FDA for Pithampur Unit-2 facility

Lupin has received the Establishment Inspection Report (EIR) from the US 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 21-29, 2023. The US 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 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, MD, Lupin.