Lupin Gets USFDA Nod for Nagpur Injectable Plant After Clean Inspection

18 Apr 2025 , 12:29 AM

Lupin Limited has got the Establishment Inspection Report (EIR) of the United States Food and Drug Administration (USFDA) for its injectables plant in Nagpur.

The clearance is on the back of a four-day USFDA inspection between June 10 and June 13, 2024. The USFDA inspection focused majorly on drug-device combination products, which is a niche but vital portion of the pharmaceutical segment.

The publication of the EIR signifies that the Nagpur plant complies with USFDA’s stringent quality control and manufacturing standards without any observations pending.

“We are pleased with the outcome,” Nilesh Gupta, Managing Director of Lupin said. “We continue to remain committed to delivering complex generics as well as critical medicines addressing unmet medical needs.”.

The approval is significant for Lupin, strengthening its position in highly regulated US generic market, wherein it is an established player. The facility at Nagpur is a large component of Lupin’s global manufacturing network for advanced injectables and life critical drugs.

Such a success testifies to the company’s proven ability to manage advanced drug-device combination products further boosting confidence for global healthcare players. Lupin, which is based in Mumbai, operates in over 100 countries and has business in branded and generic formulations, complex generics, biotech-based pharmaceuticals, and Active Pharmaceutical Ingredients (APIs).