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U.S. FDA completes inspection of Lupin’s Nagpur facility
Mumbai, August 8, 2019: Pharma major Lupin Limited (Lupin) today announced the completion of the United States Food and Drug Administration (U.S. FDA) inspection carried out at its Nagpur oral solid manufacturing facility. The inspection was carried out between August 5, 2019 and August 8, 2019.
The inspection for the oral solid facility at Nagpur closed without any 483 observations.
Commenting on the outcome of the inspection, Nilesh Gupta, Managing Director, Lupin said, “We are committed to adherence and full compliance with cGMP regulations at all our manufacturing sites. The Nagpur facility is our latest oral solid dosage facility and this was the sixth U.S. FDA inspection at the facility. We are very happy that the inspection closed with no 483s”.
About Lupin Limited
Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded and generic formulations, biosimilar 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 (December 31, 2018, Bloomberg LTM). The Company is the 3rd largest pharmaceutical player in the US by prescriptions (IQVIA MAT Mar 2019); 3rd largest Indian pharmaceutical company by global revenues (31st Dec 2018, Bloomberg LTM); 5th largest company in the Indian Pharmaceutical Market and 6th largest generic pharmaceutical player in Japan (IQVIA MAT Mar 2019).
For the financial year ended March 31, 2019, Lupin’s Consolidated sales and Net profits before exceptional items were at INR 163,694 million (USD 2.34 billion) and INR 9,466 million (USD 136 million) respectively. Please visit http://www.lupin.com for more information. You could also Lupin on Twitter at www.twitter.com/lupinglobal.
CIN: L24100MH1983PLC029442 Registered Office: Lupin Ltd, 3rd Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz (East), Mumbai 400 055.
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