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Ranbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP

Tuesday, August 21, 2007 General News
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PRINCETON, N.J., Aug. 20 Ranbaxy Pharmaceuticals Inc.(RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL),announced today that RLL has received approval from the U.S. Food and DrugAdministration to manufacture and market Hydrocodone Bitartrate andAcetaminophen Tablets USP, 7.5 mg/750 mg, 10 mg/500 mg, 5 mg/500 mg, and 10mg/325 mg strengths. The Office of Generic Drugs, U.S. Food and DrugAdministration, has determined the Ranbaxy formulations to be bioequivalentand have the same therapeutic effect as that of the reference listed drugs asfollows: 10 mg/325 mg Norco Tablets of Watson Pharmaceuticals Inc., 5 mg/500mg Vicodin Tablets, and 7.5 mg/750 mg Vicodin ES Tablets both of AbbottLaboratories, and 10 mg/500 mg Lortab Tablets of UCB Inc. Total annual marketsales for Hydrocodone Bitartrate and Acetaminophen Tablets were $390.6 million(IMS - MAT: June 2007).
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"Hydrocodone Bitartrate and Acetaminophen Tablets are indicated for therelief of moderate to moderately severe pain, and Ranbaxy is pleased toreceive final FDA approval for multiple strengths of this product. Theseapprovals further expand our product portfolio of affordable genericalternatives and will be launched in a November 2007 time period to allclasses of trade," according to Jim Meehan, Vice President of Sales andMarketing for RPI.
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Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, is awholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India's largestpharmaceutical company. RPI is engaged in the sale and distribution of genericand branded prescription products in the U.S. healthcare system.

Ranbaxy Laboratories Limited, headquartered in India, is an integrated,research based, international pharmaceutical company producing a wide range ofquality, affordable generic medicines, trusted by healthcare professionals andpatients across geographies. Ranbaxy's continued focus on R&D has resulted inseveral approvals in developed markets and significant progress in New DrugDiscovery Research. The Company's foray into Novel Drug Delivery Systems hasled to proprietary "platform technologies", resulting in a number of productsunder development. The Company is serving its customers in over 125 countriesand has an expanding international portfolio of affiliates, joint ventures andalliances, ground operations in 49 countries and manufacturing operations in11 countries.*Vicodin(R) ES Tablets is a registered trademark of Abbott Laboratories *Norco(R) Tablets is a registered trademark of Watson Pharmaceuticals Inc. *Lortab(R) Tablets is a registered trademark of UCB Inc. CONTACTS: Charles M. Caprariello Vice President, Corporate Communications Ranbaxy Inc. (609) 720-5615 Edwige Buteau RF Binder Partners Inc. (212) 994-7517 [email protected] Anuj Baveja RF Binder Partners Inc. (212) 994-7552 [email protected]

SOURCE Ranbaxy Pharmaceuticals Inc.
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