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Ranbaxy gets Australia nod for antipsychotic drug

March 25, 2009 17:15 IST

Drug major Ranbaxy on Wednesday said it has received approval from the Australian health regulator to market its antipsychotic drug Ozidal Risperidone in that country.

Ranbaxy Australia, the wholly owned subsidiary of the company, has received an approval from the Therapeutic Goods Administration for the registration of ozidal risperidone tablets in Australia, the drug manufacturer said in a filing to the Bombay Stock Exchange.

The approval was based on the assessment by the TGA that the Ranbaxy formulation of risperidone is bio-equivalent to risperdal tablets of Janssen-Cilag Australia, it added.

Risperidone is a drug used in psychiatric medicine for the treatment of schizophrenia, a form of insanity.

With the approval of this drug, Ranbaxy now has a total number of 27 molecules approved for marketing in Australia, the company said.

The approved molecules cover a wide range of therapeutic areas including anti-hypertensive, anti-infective, anti-convulsants and anti-depressants, it further said.

Earlier this week, Ranbaxy Laboratories had said that it has received good manufacturing practice certificate from the United Kingdom and Australian health regulators for its facility at Paonta Sahib in Himachal Pradesh.

Shares of Ranbaxy on Wednesday closed at Rs 162.75, down 0.76 per cent on the BSE.

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