Mumbai: Pharma Major Lupin Limited (Lupin) announced that it has received a 505 (b) (2) NDA approval for its Nikita^TM (Pitavastatin) Tablets 1 mg, 2 mg and 4 mg from the United States Food and Drug Administration (FDA).

Lupin’s Nikita^TM (Pitavastatin) Tablets 1 mg, 2 mg and 4 mg are Pitavastatin Sodium, an alternate salt product of Kowa Company Ltd’s Livalo® (Pitavastatin Calcium) Tablets. It is a new option for patients with primary hyperlipidemia or mixed dyslipidemia as an adjunctive therapy to diet to reduce elevated total cholesterol, low-density lipoprotein cholesterol, apolipoprotein B, triglycerides and to increase high-density lipoprotein cholesterol.

Livalo® Tablets had US sales of USD 272 million (IMS MAT June 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 7^th and 6^th largest generics pharmaceutical company by market capitalization (June 30^th, 2017, Bloomberg) and revenues (March 31^st, 2017, Bloomberg) respectively. The Company is the 4^th largest pharmaceutical player in the US by prescriptions (Quintiles IMS MAT March 2017); 2^nd largest Indian pharmaceutical company by global revenues (March 31^st, 2017, Bloomberg); 6^th largest generic pharmaceutical player in Japan and 6^th largest company in Indian Pharmaceutical Market (Quintiles IMS MAT June 2017).

For the financial year ended 31^st 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, 3^rd 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 Bothra
Head – Investor Relations and M&A
Ph: +91-22-66402137
Email: arvindbothra@lupin.com

*Safe Harbor Statement

Livalo® is a registered trademark of Kowa Company Ltd