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Lupin receives FDA approval for generic Crestor® tablets

Mumbai, August 03, 2017: Pharma Major Lupin Limited (Lupin) announced that it has received final approval for its Rosuvastatin Calcium Tablets 5 mg, 10 mg, 20 mg and 40 mg from the United States Food and Drug Administration (FDA) to market a generic version of iPR Pharmaceuticals, Inc’s Crestor® tablets.

Lupin’s Rosuvastatin Calcium tablets 5 mg, 10 mg, 20 mg and 40 mg is the AB rated generic equivalent of iPR Pharmaceuticals, Inc’s Crestor® tablets. It is indicated for the treatment of adult patients with hypertriglyceridemia, primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) and adult patients with homozygous familial hypercholesterolemia.

Crestor® tablets had US sales of USD 3.4 billion (IMS MAT March 2017).

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 7th and 6th largest generics pharmaceutical company by market capitalization (June 30th, 2017, Bloomberg) and revenues (March 31st, 2017, Bloomberg) respectively. The Company is the 4th largest pharmaceutical player in the US by prescriptions (Quintiles IMS MAT March 2017); 2nd largest Indian pharmaceutical company by global revenues (March 31st, 2017, Bloomberg); 6th largest generic pharmaceutical player in Japan and 6th largest company in Indian Pharmaceutical Market (Quintiles IMS MAT June 2017).

For the financial year ended 31st March, 2017, Lupin’s Consolidated sales and Net profit stood at Rs. 171,198 million (USD 2.55 billion) and Rs. 25,575 million (USD 381 million) respectively. Please visit http://www.lupin.com  for more information. You could also follow us on Twitter – www.twitter.com/lupinlimited

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
Ph: +91-22-66402531 / 9811665000
Email: poojathakran@lupin.com

or

Arvind BothraHead – Investor Relations and M&A
Ph: +91-22-66402137
Email: arvindbothra@lupin.com

*Safe Harbor Statement

Crestor® is a registered trademark of iPR Pharmaceuticals, Inc.