Drug firm Lupin on Monday said it has received an establishment inspection report (EIR) from the US health regulator post the inspection of its Nagpur facility. “The United States Food and Drug Administration (USFDA) conducted a pre-approval inspection for its Phenytoin Sodium Extended Release 100 mg capsules,” Lupin said in a filing to BSE.
The plant was inspected by USFDA in September 2018, the company added.
USFDA gives EIR on closure of inspection of an establishment that is the subject of an FDA or FDA-contracted inspection.
Commenting on the development, Lupin MD Nilesh Gupta said: “The successful completion of the Nagpur facility inspection is a positive development as we continue our journey to meet and exceed international regulatory standards.