Claris bags EU in-principle approval for anaesthetic drug

In what could give fillip to sale of its anaesthetic drug, Ahmedabad Claris Lifesciences Limited (Claris) announced on Wednesday that it has received an in-principle approval for Propofol; in the European Union (EU).

A flagship product of Claris, Propofol has been successful as an anaesthetic drug, since recovery from Propofol is more rapid and clear when compared to other anesthetic drugs, the company stated in an official statement. The molecule involves a complex manufacturing technology, and has few competitors world wide.

According to Claris, the approval will allow Claris to process the registration across 25 countries in the EU. 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 USD 750 million (Rs 3,362.54 crore approx.) world wide and in EU is estimated to be about USD 150 million (Rs 6,72.44 crore approx.). Claris is one of the few companies to have the competence to manufacture this product on a large scale and has one of the largest manufacturing capacities in India. This registration will benefit Claris as EU is a lucrative market both in terms of revenue and margins. Post approval, Propofol in EU would be a very big growth driver for Claris. The company has already received 125 approvals in Europe, while another 105 are in the pipeline. Further, it has received 95 approvals for Propofol across different geographies and another 60 registrations are in the pipeline.