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Lupin receives US FDA approval for Zileuton Extended-Release Tablets
Mumbai, Baltimore, November 08, 2019: Pharma major Lupin Limited (Lupin) announced that it has received approval for its Zileuton Extended-Release Tablets, 600 mg, from the United States Food and Drug Administration (U.S. FDA), to market a generic equivalent of Zyflo CR® Extended-Release Tablets, 600 mg, of Chiesi USA, Inc.
Lupin’s Zileuton Extended-Release Tablets, 600 mg are indicated forprophylaxis and chronic treatment of asthma in adults and children 12 years of age and older.
Zileuton Extended-Release Tablets, 600 mg had annual sales ofapproximately USD 43 million in the U.S. (IQVIA MAT September2019).
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 (June 30, 2019, Bloomberg LTM). The Company is the 3rd largest pharmaceutical player in the US by prescriptions (IQVIA MAT September 2019); 3rd largest Indian pharmaceutical company by global revenues (June 30, 2019, Bloomberg LTM); 6th largest company in the Indian Pharmaceutical Market and 5th largest generic pharmaceutical player in Japan (IQVIA MAT September 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 follow us on Twitter at – www.twitter.com/lupinglobal
CIN: L24100MH1983PLC029442 Registered Office: Lupin Ltd, 3rdFloor, Kalpataru Inspire, Off Western Express Highway, Santacruz (East), Mumbai 400 055.
For further information or queries please contact –
Head – Investor Relations and M&A / Corporate Communications
Zyflo CR® is a registered trademark of Chiesi USA, Inc.