Last updated on April 16, 2014 at 7:25 EDT

Lupin Receives FDA Approval for New Drug Application for SUPRAX® Oral Suspension, 500 mg/5mL

February 22, 2013

MUMBAI, India and BALTIMORE, February 22, 2013 /PRNewswire/ –

Approval to add to growing SUPRAX(R) Franchise

Pharma major, Lupin Ltd., announced today that its subsidiary, Lupin Pharmaceuticals
Inc. (collectively, Lupin) has received approval for SUPRAX(R) (Cefixime) for Oral
Suspension, 500 mg/5mL from the United States Food and Drugs Administration (FDA). Lupin
expects to commence shipping the product in the near future.

The approval will expand Lupin’s range of SUPRAX(R) dosage forms available to treat
approved indications in appropriate patients. SUPRAX(R) is currently available as 100
mg/5ml and 200 mg/5ml suspensions; 400 mg tablets as well as chewable tablets 100 & 200

This new drug application provides for a new strength, 500mg/5mL, of SUPRAX (cefixime)
for Oral Suspension for the treatment of otitis media, acute exacerbation of chronic
bronchitis, uncomplicated urinary tract infections, uncomplicated gonorrhea
(cervical/urethral) and pharyngitis/tonsillitis.

Commenting on the approval, Ms. Vinita Gupta, Group President, Lupin Limited & CEO,
Lupin Pharmaceutical Inc. said “We are happy to receive this approval. The new dosage form
will add to our growing SUPRAX franchise and gives health care providers and patients a
new formulation to treat the indicated infections. The approval of SUPRAX for Oral
Suspension is one more example of our ongoing commitment to serving our customers and
addressing their needs.”

About Lupin Limited

Headquartered in Mumbai, Lupin is an innovation led transnational pharmaceutical
company producing and developing a wide range of branded and generic formulations and
APIs. The Company is a significant player in the Cardiovascular, Diabetology, Asthma,
Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership positions
in the Anti-TB and Cephalosporin segment.

Lupin is the 5th largest and fastest growing generics player in the US (5.1% market
share by prescriptions, IMS Health) and the 3rd largest Indian pharmaceutical company by
sales. The Company is also the fastest growing top 10 generic pharmaceutical players in
Japan and South Africa (IMS).

For the financial year ended March 2012, Lupin’s Consolidated Total Income and Profit
after Tax were Rs. 70,972 million (USD 1.49 billion) and Rs.8,676 million (USD 182
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

SOURCE Lupin Ltd

Source: PR Newswire