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Claris Lifesciences (Claris) today said it has received an in-principle approval for its drug Propofol in the European Union (EU) which will allow the company to process the registration across 25 countries.
Propofol, a flagship product of Claris is an anaesthetic product which is widely replacing other anaesthetic drugs as recovery from Propofol is more rapid and clear when compared to other anaesthetic drugs.
The molecule involves a complex manufacturing technology and has few competitors worldwide.
The in-principle approval for Propofol will allow the company to process the registration across 25 countries in the EU. This registration will benefit Claris as EU is a lucrative market both in terms of revenue and margins. Going ahead, Propofol in EU would be a very big growth driver for Claris, a release issued here said.
Claris has already received 125 approvals in Europe, while another 105 are in the pipeline. It has received 95 approvals for Propofol across different geographies and another 60 registrations are in the pipeline.
Europe has one of the most complex procedures for obtaining regulatory approvals and Claris is one of the few companies to have received approval for Propofol in Europe.
The market size for Propofol is estimated to be at $750 million worldwide and in EU is estimated to be about $150 million, it said.
Claris Lifesciences is one of the largest sterile injectables pharmaceutical companies in India with a market presence across 76 countries.
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