Express Pharma

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

The EIR was issued post the last inspection of the facility conducted from March 21-29, 2023

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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.

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