Indian pharma major Lupin on October 31 said it 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. Lupin had a consolidated net profit of Rs 453.33 crore for the April-June quarter FY24, as against a consolidated net loss of Rs 86.8 crore reported in the same period a year ago.
Lupin has 15 manufacturing sites, 7 research centers and over 20,000 professionals working globally.
Lupin will release its Q2 results on 8th November 2023. Shares of the drug firm ended 1.04 per cent down at Rs 1,128.40 apiece on the BSE.
Discover the latest Business News, Sensex, and Nifty updates. Obtain Personal Finance insights, tax queries, and expert opinions on Moneycontrol or download the Moneycontrol App to stay updated!
