Ranbaxy receives tentative approval from US FDA for 'Risperidone'
New Delhi, Aug 4 (UNI) Ranbaxy Laboratories Limited (RLL), India's largest pharmaceutical company, today said it has received tentative approval from the US Food and Drug Administration (US FDA) to manufacture and market 1mg/ml of the Risperidone Oral Solution.
''We are pleased to receive this tentative approval for Risperidone Oral Solution. This product represents a future opportunity for Ranbaxy and will be launched following final approval from the US FDA,'' Ranbaxy Pharmaceuticals Inc (RPI) US Sales and Marketing VP Jim Meehan said.
US-based RPI, is a wholly owned subsidiary of RLL, and is engaged in the sale and distribution of generic and branded prescription products in the US healthcare system.
Risperdal (Risperidone) oral solution, which is used to treat schizophrenia, registered total annual market sales of 66 million dollars as on March, 2006.
RLL is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines.
The company's foray into Novel Drug Delivery Systems has led to proprietary ''platform technologies'', resulting in a number of products under development.
The company serves its customers 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 8 countries.
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