The filing is from Lupin’s Goa manufacturing facility

Mumbai: Pharma Major Lupin Limited (Lupin) announced today that it has received final approval for its Bupropion Hydrochloride Extended-Release tablets USP (XL), 150 mg and 300 mg from the United States Food and Drug Administration (FDA) to market a generic version of Wellbutrin XL® tablets, 150 mg and 300 mg.

Lupin’s Bupropion Hydrochloride Extended-Release tablets USP (XL), 150 mg and 300 mg are the AB rated generic equivalent of Valeant Pharmaceuticals North America, LLC’s Wellbutrin XL® tablets, 150 mg and 300 mg. It is indicated for the treatment of major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD) in adults.

Wellbutrin XL® tablets had US sales of USD 755 million (IMS MAT December 2016).

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 5^th and the 6^th largest generics pharmaceutical company by market capitalization (December 31^st, 2016, Bloomberg) and sales globally (September 30^th, 2016, Bloomberg). The Company is the 5^th largest pharmaceutical player in the US by prescriptions (4.3% market share – IMS MAT December 2016); the 2^nd largest Indian pharmaceutical company by revenues; the 6^th largest generic pharmaceutical player in Japan and the 4^th largest generic pharmaceutical company in South Africa (IMS Health, March 2016).  For the financial year ended 31^st March, 2016, Lupin’s Consolidated sales and Net profit stood at Rs. 136,539 million (USD 2.09 billion) and Rs. 22,607 million (USD 345 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

Wellbutrin XL® is a registered trademark of GlaxoSmithKline LLC used under license. ©Valeant Pharmaceuticals

North America LLC