MUMBAI, India, Dec. 9 /PRNewswire-FirstCall/ -- Lupin Ltd. today announced that it has received US FDA approval for its Abbreviated New Drug Application (ANDA) for Cefprozil Tablets USP, 250 mg and 500 mg. Cefprozil is the generic equivalent of Bristol-Myers Squibb’s Cefzil(R). The tablet market in the US is USD 117 million as per IMS MAT June 2005 data.
Speaking of the approval, Chairman Dr. D B Gupta said: “We are delighted with the approval of Cefprozil Tablets and look forward to launching the product post patent expiry on Dec. 23rd, 2005, and gaining a profitable market share. The expeditious review and approval by the US FDA is a sign of their confidence in Lupin and the quality of our filings.”
This is Lupin’s ninth ANDA approval by the US FDA to date and the fourth in this financial year.
About Lupin
Lupin Pharmaceuticals, Inc. is the wholly owned U.S. subsidiary of Lupin Limited. Headquartered in Mumbai, Lupin (http:/www.lupinworld.com) develops, manufactures and markets generic intermediates, active pharmaceutical ingredients and finished dosages. Its FY 2004-05 revenues were Rs.12 billion. Eleven of Lupin’s plants have been approved by the US FDA and two facilities have been approved by the UK MHRA.
For further information contact: Leslie Leader Lupin Pharmaceuticals, Inc. Telephone: 410-576-2000 Email: admin@lupinusa.com
Lupin Pharmaceuticals, Inc.
CONTACT: Leslie Leader of Lupin Pharmaceuticals, +1-410-576-2000,admin@lupinusa.com
