Lupin gets EIR from U.S. FDA for Pithampur unit-2 manufacturing facility

The United States Food and Drug Administration (U.S. FDA) issued the Establishment Inspection Report (EIR) for Lupin Limited’s Pithampur Unit-2 manufacturing facility, which creates oral solids and ophthalmic dosage forms.

“Global pharma major Lupin Limited (Lupin) today 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,” the pharma company said in the filing.

The EIR was released following the facility’s most recent inspection, which took place between March 21 and March 29, 2023.

The facility’s inspection categorization has been found by the U.S. FDA to be 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 product approvals and launches, especially ophthalmic products from this facility now,” said Nilesh Gupta, Managing Director, Lupin said in a statement.

Source: Media reports