Lupin Receives FDA Approval for Generic Ortho Tri-cyclen Lo® Tablets

News provided by

Lupin Ltd

03 Jul, 2012, 13:08 GMT

MUMBAI and BALTIMORE, July 3, 2012 /PRNewswire/ --

BSE : 500257 
NSE: Lupin 
REUTERS: LUPN.BO    
BLOOMBERG: LPC IN

Pharma major, Lupin Ltd., announced today that its subsidiary, Lupin Pharmaceuticals Inc. (collectively, Lupin) has received approval for its Norgestimate and Ethinyl Estradiol Tablets, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg from the United States Food and Drugs Administration (FDA).

Lupin's Norgestimate and Ethinyl Estradiol Tablets are the AB-rated generic equivalent of Ortho Tri-cyclen Lo® Tablets,0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, of Janssen Pharmaceuticals, Inc.. Norgestimate and Ethinyl Estradiol Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

Ortho Tri-cyclen Lo® Tablets had annual U.S sales of approximately US$ 421 million for the twelve months ending March 2012 (IMS Health sales data).

About Lupin Limited

Headquartered in Mumbai, Lupin is an innovation led transnational pharmaceutical company producing a wide range of generic and branded formulations and APIs. The Company today has significant presence in the Cardiovascular, Diabetology, Asthma, Paediatrics, CNS, GI, Anti-Infective and NSAID space in addition to holding global leadership positions in the Anti-TB and Cephalosporin segments.

Lupin is the 5th largest and fastest growing generics player in the US (5.1% market share by prescriptions, IMS Health), the only Asian company to achieve that distinction. The company is also the fastest growing top 10 pharmaceutical player in India, Japan and South Africa (IMS).

For the financial year ended March 2012, Lupin's Consolidated Revenues and Profit after Tax were Rs.70,829 Million (USD 1.42 Billion) and Rs. 8,676 Million (USD 190 million) respectively. Please visit http://www.lupinworld.com for more information.

Lupin Pharmaceuticals, Inc. is the wholly owned U.S. subsidiary of Lupin Limited.  Headquartered in Baltimore, Maryland, Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality, affordable generic medicines and branded formulations trusted by healthcare professionals and patients across geographies. For more information, visit http://www.lupinpharmaceuticals.com.

Safe Harbor Statement

*Ortho Tri-cyclen Lo Tablet® are a registered copyright of Janssen Pharmaceuticals, Inc..

For further information or queries, please contact -

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

SOURCE Lupin Ltd