Pharma major Lupin Limited (Lupin) today announced the receipt of the Establishment Inspection Report (EIR) from the U.S. FDA for its Nagpur facility. The facility was inspected by the U.S. FDA between August 5, 2019 and August 8, 2019.

The inspection for the oral solid facility at Nagpur closed without any Form 483 observation.  The Nagpur facility is Lupin’s largest and most advanced oral solid dosage facility and has maintained a solid track record of compliance.

Commenting on the receipt of the EIR, Nilesh Gupta, Managing Director, Lupin said, “Excelling at Quality and Compliance is one of our top priorities and we remain committed to meeting and exceeding standards set by regulatory agencies globally.”

About Lupin Limited

 Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.

Lupin is the 8th largest generics pharmaceutical company by revenues (31st Mar 2019, Bloomberg LTM) respectively. The Company is the 3rd largest pharmaceutical player in the US by prescriptions (IQVIA MAT Jun 2019); 3rd largest Indian pharmaceutical company by global revenues (31st Mar 2019, Bloomberg LTM); 5th largest generic pharmaceutical player in Japan and 6th largest company in the Indian Pharmaceutical Market (IQVIA MAT Jun 2019).