US FDA issues EIR for Lupin’s injectable facility in Nagpur
Lupin receives Establishment Inspection Report for injectable unit following US FDA inspection in June 2024
Lupin has announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its injectable manufacturing facility in Nagpur, India. The report pertains specifically to the company’s drug-medical device combination products.
The EIR follows an inspection of the facility carried out by the US FDA between 10 and 13 June 2024.
Commenting on the development, Nilesh Gupta, Managing Director, Lupin, said, “We are very pleased to have received the EIR from the US FDA for drug-device combination products at our Nagpur injectable facility. We remain committed to producing complex generic and essential products that address unmet needs.”
The approval allows Lupin to move forward with its manufacturing and distribution plans for drug-device combination therapies in the United States market.