Mumbai: Pharma major Lupin Limited (Lupin) today announced the receipt of the Establishment Inspection Report (EIR) from the U.S. FDA for its Aurangabad facility. The facility was inspected by the U.S. FDA between May 6, 2019 and May 15, 2019.
Lupin’s Aurangabad facility is involved in the manufacture of Oral Solid Dosage, Oral Liquid and Powder for Oral Suspension products for the US Market, WHO/Global Institution markets and the India market.
Commenting on the development, Nilesh Gupta, Managing Director, Lupin said, “Lupin is committed to adherence and full compliance with cGMP regulations and all other applicable regulatory requirements at our manufacturing sites. We are very happy to receive the EIR for our Aurangabad facility marking the satisfactory closure of the US FDA inspection.”
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 (31st Dec 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 31st March 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 follow us 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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