Ranbaxy receives final US FDA approval to manufacture & market Zolpidem Tablets in USA

Ranbaxy Laboratories Ltd on April 26, 2007 has announced 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 Company's 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 he 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 the Company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.

The stock was trading at Rs.371.60, up by Rs.2.50 or 0.68%. The stock hit an intraday high of Rs.375.85 and low of Rs.365.30. The total traded quantity was 248956 compared to 2 week average of 334541.

Source : Equity Bulls

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