Lupin largest, most advanced oral solid dosage facility gets EIR from USFDA

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

Mumbai: Pharma major Lupin Limited (Lupin) recently 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," Lupin said in a release.

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.”

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Lupin is a player in Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space. It is the 8th largest generics pharmaceutical company by revenues (31st Mar 2019, Bloomberg LTM) respectively.

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