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Lupin’s Alliance Partner Concord Receives Approval for Mycophenolic Acid Delayed-Release Tablets USP
Mumbai, Baltimore, December 19, 2019: Pharma major Lupin Limited (Lupin) in alliance with Concord Biotech Limited (Concord)announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for Mycophenolic Acid Delayed-Release Tablets USP, 180 mg and 360 mg, to market the generic equivalent of Myfortic® Delayed-Release Tablets, 180 mg and 360 mg, of Novartis Pharmaceuticals Corporation.
Mycophenolic Acid Delayed-Release Tablets USP, 180 mg and 360 mg, are indicated for:
• Prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant.
• Use in combination with cyclosporine and corticosteroids.
Mycophenolic Acid Delayed-Release Tablets USP, 180 mg and 360 mg(RLD: Myfortic®) had an annual sales of approximately USD 174million in the U.S. (IQVIA MAT September 2019).
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) and 6th largest company in the Indian pharmaceutical market (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 163,694million (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
Myfortic® is a registered trademark of Novartis AG Corporation Switzerland
Vinita Gupta is the CEO of Lupin Limited (Lupin) and Chairperson of Lupin Inc., (LI) and its US subsidiary, Lupin Pharmaceutical Inc. (LPI).
Vinita is a graduate in pharmacy from the University of Mumbai and earned an MBA degree at the Kellogg School of Management at Northwestern University. Vinita has been instrumental in formulating and executing a strategy that has helped the company emerge as a global pharmaceutical powerhouse; amongst the most exciting growth stories in the pharmaceutical industry. Through a combination of organic growth and strategic acquisitions, she has led the company’s global expansion plans. In particular, she founded, led and established Lupin’s largest region, the United States.
Vinita has been regularly named by Forbes Asia in its Top 50 Power Business women listings for Asia Pacific. Vinita was also recognized by Business Today Hall of Fame – Most Powerful Women in Business in 2016 and was recently named Outstanding Business Woman Leader of the Year by CNBC India Business Leader Awards. She was the winner of the inaugural EY, U.S. 2012 Family Business Award of Excellence and EY Entrepreneur Of the Year® 2012 award winner for Health Services and Technology in Maryland. She is regarded as amongst the most influential Indian Business Women globally.
Vinita along with her brother Nilesh (Managing Director, Lupin Limited) were named Ernst & Young (EY) Entrepreneur of The Year 2015 and won the Forbes India Leadership Awards 2016, Entrepreneur of the Year.
In 2017 Vinita was appointed to the board of directors for Intrexon Corporation. She is also a member of the Global Advisory Board at the Kellogg School of Management at Northwestern University.
Mr. Nilesh Gupta is the MD of Lupin Limited and a member of the Board of Directors. Having joined Lupin in 1996, Mr. Gupta led Lupin’s research, supply chain, manufacturing, quality and regulatory operations, and took charge as the company’s Managing Director in 2013. He has not only been responsible for transforming Lupin’s research program and expanding the company’s manufacturing operations but has also been instrumental in formulating and executing the core strategy that has helped Lupin emerge as a global specialty pharmaceutical major.
Mr. Gupta, along with his sister Vinita Gupta, won the Entrepreneur of the Year award at Forbes India Leadership Awards in 2016 as well as Ernst & Young ‘Entrepreneur of the Year Award’ in India in 2015, also with his sister Vinita Gupta.
Mr. Gupta is a Chemical Engineer from the University Department of Chemical Technology (UDCT) (now ICT), Mumbai, and a graduate with honours from the Wharton School, University of Pennsylvania, USA, where he specialized in healthcare, strategic management and finance.