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Aurobindo Obtains Final Approval For Risperidone Oral Solution

Published: 07-Sep-2009

Risperidone Oral Solution, indicated for the treatment of schizophrenia

Aurobindo Pharma (Aurobindo) has received the final approval for Risperidone Oral Solution 1mg/ml (ANDA No. 78-452) from the FDA.

Risperidone Oral Solution 1mg/ml is generic equivalent to Risperdal Oral Solution 1mg/ml of Ortho-McNeil Janseen. Risperidone Oral Solution is indicated in the treatment schizophrenia and falls under the neurological (CNS) segment.

Aurobindo has currently, a total of 102 ANDA approvals (74 fanal and 28 tentative) from the FDA.

India-based Aurobindo Pharma, manufactures generic pharmaceuticals and active pharceutical ingredients. The company's manufacturing facilities are approved by several several regulatory agencies like FDA, UK MHRA, WHO, Health Canada, MCC South Africa, ANVISA Brazil.

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