Ranbaxy receives final approval to mfg, mkt Zolpidem tabs

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Ranbaxy receives final approval to mfg, mkt Zolpidem tabs

Ranbaxy receives final USFDA approval to manufacture and market Zolpidem Tablets in USA

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Ranbaxy Laboratories Limited (RLL), announced today that the Company has received approval from the U.S. Food and Drug Administration to manufacture and market Zolpidem Tartrate Tablets, 5mg and 10mg. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulation to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug Ambien® Tablets 5mg and 10mg of Sanofi Aventis US , LLC.  The product will be manufactured at the company's Ohm Laboratories Inc. facility, based in New Brunswick, New Jersey, USA.  Zolpidem Tartrate Tablets are indicated for the short-term treatment of insomnia characterized by difficulty with sleep intervention, with total annual market sales in the U.S. of $2.12 billion (IMS - MAT: December 2006). 

"We are pleased to receive this final approval for Zolpidem Tartrate Tablets.  This product will be launched immediately and presents yet another opportunity for Ranbaxy to expand its product portfolio by offering an affordable generic alternative for a molecule that has proven clinical value," according to Jim Meehan, Vice President of Sales and Marketing for Ranbaxy Pharmaceuticals Inc., USA.

Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, USA, is a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India's largest pharmaceutical company.  RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.

Sourced From: Ranbaxy Laboratories Ltd