Mumbai: Pharma Major Lupin Limited (Lupin) announced today that it has received final approval for its Oxycodone Hydrochloride Tablets USP, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg from the United States Food and Drug Administration (FDA) to market a generic version of Mallinckrodt Inc.’s Roxicodone® Tablets.

Lupin’s Oxycodone Hydrochloride Tablets USP, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg is the AB rated generic equivalent of Mallinckrodt Inc.’s Roxicodone® Tablets. Oxycodone Hydrochloride Tablets USP, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Roxicodone® Tablets had US sales of USD 344 million (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 4^th and the 6^th largest generics pharmaceutical company by market capitalization (March 31^st, 2017, Bloomberg) and sales globally (December 31^st, 2016, Bloomberg). The Company is the 5^th largest pharmaceutical player in the US by prescriptions (Quintiles IMS MAT Feb 2017); the 2^nd largest Indian pharmaceutical company by global revenues; the 6^th largest generic pharmaceutical player in Japan and the 4^th largest generic pharmaceutical company in South Africa (Quintiles IMS MAT March 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 –

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

*Safe Harbor Statement

Roxicodone® is a registered trademark of Mallinckrodt LLC Limited.