USFDA completes inspection of Lupin's Aurangabad facility
Mumbai: Pharma major Lupin Limited (Lupin) announced the completion of the United States Food and Drug Administration (U.S. FDA) inspection carried out at its Aurangabad manufacturing facility. The inspection was carried out from May 6 to May 15, 2019.
The inspection at the Aurangabad facility closed with three observations. The Company is confident of addressing them satisfactorily.
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 a 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.