Pharma major Ranbaxy Laboratories on Friday said it has received tentative approval from US Food and Drug Administration (USFDA) to manufacture and market Zolpidem Tartrate Tablets, used in the treatment of Insomnia and related disorders.
In a communique to the Bombay Stock Exchange, Ranbaxy said under the USFDA approval it can manufacture and market Zolpidem Tartrate Tablets of 5mg and 10mg.
"This product will be launched following final approval from the FDA and presents yet another opportunity for Ranbaxy to expand its product portfolio by offering an affordable generic alternative," Ranbaxy Pharmaceuticals Inc, USA Vice President of Sales and Marketing Jim Meehan said.
The office of generic drugs, USFDA has determined the Ranbaxy formulations to be bioequivalent and to have the same therapeutic effect as that of the reference listed drug Ambien Tablets 5mg and 10mg of Sanofi Aventis US, LLC, it added.
The products would be manufactured at Ranbaxy's Ohm Laboratories Inc facility, at New Jersey, USA.
Ranbaxy Pharmaceuticals Inc engaged in the sale and distribution of generic and branded prescription products in the US healthcare system is a wholly owned subsidiary of Ranbaxy Laboratories.