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Biocon India gets USFDA nod

BANGALORE: Biocon India has received an approval from the US FDA for the manufacture of Lovastatin, a cholesterol reducing drug which goes off patent in June 2001. Biocon is one of the three companies in the world and the only one in the country to have got the approval.

There is a $ 15-billion market for the Statins (a group of cholesterol reducing drugs which include Simvastatin, pravastatin, atorvastatin and cerevanstatin) collectively.

Lovastatin is the first to come off patent later this year, followed by Simvastatin and pravastatin. The market for lovastatin is just under $ 1 billion, but is expected to increase once the generic molecule is introduced into the market.

Biocon India has a focussed statin strategy and currently markets Lovastatin, Simvastatin, pravastatin and atorvastatin to various unregulated international market segments and hopes to be a global player in statin production. Biocon's lovastatin process is based on the proprietary fermentation technology and is the first fermentation process in the country to be approved by the US FDA. -- Our Bureau