Last updated on April 23, 2014 at 13:51 EDT

Lupin Receives FDA Approval for Generic LYRICA(R)

July 5, 2012

MUMBAI and BALTIMORE, July 5, 2012 /PRNewswire/ –

Pharma major, Lupin Ltd., announced today that its subsidiary, Lupin Pharmaceuticals
Inc. (collectively, Lupin) has received final approval for its Pregabalin Capsules, 25 mg,
50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg from the United States Food and
Drugs Administration (FDA) to market a generic version of C.P. Pharmaceuticals C.V.,
LYRICA(R) (Pregabalin) capsules.

Lupin’s Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and
300 mg are the AB-rated generic equivalent of LYRICA(R) capsules, which is indicated for
neuropathic pain associated with diabetic peripheral neuropathy, post herpetic neuralgia,
adjunctive therapy for adult patients with partial onset seizures and fibromyalgia.

LYRICA(R) Capsules had annual U.S sales of approximately $1.8 billion 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 (5.3% 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


        For further information or queries, please contact -
        Shamsher Gorawara
        Head - Corporate Communications
        Lupin Limited:
        Ph: +91-98-20-338-555
        Email: shamshergorawara@lupinpharma.com

Safe Harbor Statement [http://www.lupinworld.com/safe harbor ]

*LYRICA(R) is a registered trademark of C.P. Pharmaceuticals, C.V. a wholly owned
subsidiary of Pfizer, Inc.

SOURCE Lupin Ltd

Source: PR Newswire