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Lupin receives U.S. FDA approval for Ethacrynic Acid Tablets USP
Mumbai, Baltimore, September 9, 2019: Pharma major Lupin Limited (Lupin) announced that it has received approval for its Ethacrynic Acid Tablets USP, 25 mg, from the United States Food and Drug Administration (U.S. FDA).
Lupin’s Ethacrynic Acid Tablets USP, 25 mg, is the generic version of Edecrin® Tablets, 25 mg, of Bausch Health Americas, Inc. It is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required.
Ethacrynic Acid Tablets USP (RLD: Edecrin® Tablets) had annual sales of approximately USD 24 million in the US (IQVIA MAT June 2019).
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 by revenues (31st Mar 2019, Bloomberg LTM) respectively. The Company is the 3rd largest pharmaceutical player in the US by prescriptions (IQVIA MAT Jun 2019); 3rd largest Indian pharmaceutical company by global revenues (31st Mar 2019, Bloomberg LTM); 5th largest generic pharmaceutical player in Japan and 6th largest company in the Indian Pharmaceutical Market (IQVIA MAT Jun 2019).
For the financial year ended 31st March, 2019, Lupin’s Consolidated sales and Net profits were at Rs. 163,694 million (USD 2.34 billion) and Rs. 9,466 million (USD 136 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.
For further information or queries please contact –
Pooja Thakran VP – Corporate Communications Email: poojathakran@lupin.com Ph: +91-22-66402531 / 8291013225
Or
Arvind Bothra Head – Investor Relations Email: arvindbothra@lupin.com Ph: +91-22-66408237
*Safe Harbor Statement
Edecrin® is the registered trademark of Aton Pharma, Inc.