Ranbaxy gets USFDA nod to market its anti-diarrhoeal drugs
New Delhi, Sep 11 (UNI) Ranbaxy Laboratories Ltd (RLL) today said it has received approval from the US Food and Drug Administration to manufacture and market its anti-diarrhoeal drugs, Loperamide Hydrochloride and Simethicone, 2 mg/125 mg (OTC).
Loperamide Hydrochloride and Simethicone Tablets (OTC) are indicated for controlling symptoms of diarrhea plus bloating, pressure, and cramps commonly referred to as gas. Loperamide is the generic equivalent of McNeil PPC Inc's Imodium.
The annual market for these drugs is 25.3 million dollars, the drug major said in a statement.
The drugs in multiple strengths will be made by Ohm Laboratories Inc, Ranbaxy's wholly-owned subsidiary in the United States.
According to Mr Robert Haywood, Senior Director of OTC Sales and Marketing of Ohm Laboratories Inc, ''Ohm will again be a leading participant in the launch of another successful Loperamide formulation. This will be marketed on a 180-day exclusive basis in the private label/store brand segment of major US retailers and wholesalers. Ohm plans to ship when sufficient supplies are produced to meet the demands of the marketplace.'' Ohm is engaged in the sale and distribution of generic and branded private label, OTC products in the US healthcare system.
RLL serves in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in eight countries.
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