Lupin Receives Tentative Approval for Generic Avelox® Tablets


Mumbai, September 06, 2016: Pharma Major Lupin Limited announced today that its US subsidiary, Gavis Pharmaceuticals LLC., U.S.A. (collectively Lupin) has received tentative approval for its Moxifloxacin Hydrochloride Tablets, 400 mg from the United States Food and Drug Administration (FDA) to market a generic version of Bayer Healthcare Pharmaceuticals Inc.’s Avelox® Tablets, 400 mg (base).

Lupin’s Moxifloxacin Hydrochloride Tablets, 400 mg are the AB rated generic equivalent of Bayer Healthcare Pharmaceuticals Inc.’s Avelox® Tablets, 400 mg (base). It is a fluoroquinolone antibacterial indicated for treating infections in adults 18 years of age and older caused by designated susceptible bacteria in certain conditions.

Avelox® had US sales of USD 30.1 million (IMS MAT June 2016).

About Lupin Limited

Lupin is an innovation led transnational pharmaceutical company producing and developing 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 5th largest pharmaceutical player in the US (4.68% generic market share by prescriptions – IMS Health, National Prescription Audit, MAT March 2016) and the 2nd largest Indian pharmaceutical company by market capitalization. The Company is also the 6th largest generic pharmaceutical player in Japan and the 4th largest generic pharmaceutical company in South Africa (IMS Health, March 2016).

For the financial year ended 31st 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, 3rd Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz (East), Mumbai 400 055.

For further information or queries please contact – 

Shamsher Gorawara, Head – Corporate Communications
Lupin Limited
Ph: +91 98 20 338 555
Email: shamshergorawara@lupin.com

*Safe Harbor Statement

Avelox® is the registered trademark of Bayer Aktiengesellschaft.