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Regulatory Bodies & Rulings
Ranbaxy gets USFDA nod for diarrhoea drug
Our Bureau
New Delhi, Sept. 11
Ranbaxy Laboratories Ltd today said it has received approval from the USFDA to manufacture and market Loperamide Hydrochloride and Simethicone tablets. The drug maker informed the BSE that it received approval for manufacturing and marketing the tablets in dosages of 2mg/125mg (over-the-counter).
Loperamide Hydrochloride and Simethicone Tablets (OTC) are indicated for controlling symptoms of diarrhoea plus bloating, pressure, and cramps. "Ohm will again be a leading participant in the launch of another successful and proven Loperamide formulation. This will be marketed on a 180-day exclusive basis in the private label brand segment of major US retailers and wholesalers," the Ohm Laboratories Inc Senior Director (OTC Sales and Marketing), Mr Robert Haywood, said.
Ohm Laboratories, Ranbaxy's US-based subsidiary, is engaged in the sale and distribution of generic and branded private label, OTC products in the US healthcare system.
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