Lupin has received Establishment Inspection Report (EIR) from the US health regulator for its Mandideep Unit-2 manufacturing facility in Madhya Pradesh.

The inspection closed with the facility receiving an inspection classification of "No Action Indicated" (NAI).

The inspection of the facility conducted from August 7 to August 11, 2023, Lupin said in a regulatory filing.

“We are pleased to receive the EIR with a satisfactory inspection status from the U.S. FDA for the recent inspection of our Mandideep Unit-2 facility. This accomplishment is in line with our continued focus and commitment to becoming best-in-class in quality and compliance, and enables us to continue delivering quality affordable healthcare solutions globally,” said Nilesh Gupta, Managing Director, Lupin in a press statement.

Mandideep site was caught under regulatory challenges since November 2022 and the management had said that it was addressing the US FDA's warning letters to the company in its first quarter results investor meet.