Lupin's Pithampur Unit-3 (Indore) Inspected by US FDA
Mumbai, October 19, 2018: Pharma major Lupin announced today the completion of a US FDA inspection carried out at its Pithampur Unit-3 (Indore) facility. The inspection was a GMP inspection for the facility and also a Pre-Approval Inspection (PAI) for the company’s Tiotropium DPI ANDA. The inspection at the site was conducted between October 8, 2018 and October 18, 2018.
The inspection closed with five observations. These observations are procedural in nature.
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 both in terms of market capitalization (30th June 2018, Bloomberg) and revenues (31st March 2018, Bloomberg LTM) globally. The Company is the 4th largest pharmaceutical player in the US by prescriptions (IQVIA MAT June 2018); 3rd largest Indian pharmaceutical company by global revenues (31st March 2018, Bloomberg LTM); 6th largest generic pharmaceutical player in Japan and 5th largest company in the Indian Pharmaceutical Market (IQVIA MAT June 2018).
For the financial year ended 31st March, 2018, Lupin’s Consolidated sales and Net profits before exceptional items were at Rs. 155,598 million (USD 2.41 billion) and Rs. 13,934 million (USD 216 million) respectively. Please visit http://www.lupin.com for more information. You could also follow us on Twitter – 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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