Lupin Receives FDA Approval for SUPRAX® (Cefixime) Capsules, 400 mg NDA Approval to add to growing SUPRAX® Franchise
MUMBAI, India and BALTIMORE, June 5, 2012 /PRNewswire/ --
Pharma major, Lupin Ltd., announced today that its subsidiary, Lupin Pharmaceuticals Inc. (collectively, Lupin) has received approval for SUPRAX® (Cefixime) Capsules 400 mg 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® dosage forms available to treat the approved indications in appropriate patients. SUPRAX® is currently available as 100 mg/5ml and 200 mg/5ml suspensions as well as 400 mg tablets.
Commenting on the approval, Mr. Nilesh Gupta, Group President & Executive Director, Lupin Limited, 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 capsules 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 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., with revenues in excess of UD 500 Million, 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.
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SOURCE Lupin Ltd