Lupin Receives US FDA EIR for Drug-Device Combination products at Nagpur Injectable Facility

🔸 Global pharmaceutical major Lupin Limited announced today that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its injectable manufacturing facility located in Nagpur, India. The EIR pertains specifically to the facility’s capability to produce drug-medical device combination products.

The US FDA Conducted a pre-approval inspection at the site from June 10 to June 13, 2024. Following a successful evaluation, the regulatory body issued the EIR, signifying that the inspection has been closed and the agency has no outstanding concerns at this time.

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.”

This positive outcome marks a significant milestone for Lupin’s efforts to expand its global footprint in the complex generics and combination products space. The Nagpur facility plays a crucial role in the company’s strategy to deliver high-quality, affordable medicines to markets worldwide, including the United States.