The report follows a four-day inspection conducted between June 10 and 13, 2024, covering drug-device combination products. The EIR indicates that the FDA has reviewed the inspection findings and concluded that the facility meets its quality and manufacturing standards, with no outstanding concerns.
“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,” said Nilesh Gupta, Managing Director of Lupin.
The clearance is expected to enhance Lupin’s standing in the highly regulated US generics market, where it already has a strong presence. The Nagpur site is a critical part of its global manufacturing network, particularly for complex injectables and essential medicines.
Following the announcement, Lupin shares recovered from the day’s low of ₹1,922.10 to trade flat at ₹1,941.35, up 0.3% on the BSE at 3:00 PM.
Headquartered in Mumbai, Lupin operates in over 100 markets and is engaged in developing branded and generic formulations, complex generics, biotechnology products, and APIs.
