Claris gets Netherlands nod to sell Propofol

Claris Lifesciences has got approval to market Propofol molecule in the Netherlands. The nod "� the first one from Europe for the company "� will mark its Netherlands entry.

Provive is the brand name of the molecule in the international market. Profol is the market leader in India and several countries across Latin America, Asia, the CIS and Africa. The company markets it in over 35 countries globally.

The market for the local injectable anesthesia Propofol is about $1.5-2 million in Netherlands and Claris aims to tap 35 percent of it by mid 2007, according to company sources.

This approval marks the entry of Provive or Profol into the highly regulated EU market, through Mutual Recognition Procedure (MRP).

MRP is a fast-track procedure introduced by EMEA (European Medicinal Products Evaluation Agency), a nodal agency which facilitates speedy entry of a product within the entire European Union through mutual recognition, thereby reducing time spent in making individual registration applications for different countries, sources further informed.

A company official said, "The company has made over 37 submissions to the EU including UK, France, Germany, Netherlands and Nordic countries. With a market size of about $20 billion in injectables, Europe is the second largest market in the world, and a pivotal market for the company's growth strategy, focusing on regulated markets."

The company will begin its supply of Propofol to Netherlands by next month.

"We will have our own marketing team in Netherlands and do not plan to enter into a strategic tie-up as of now," a company official maintained.

The company already has in place a network of its offices, team and distribution partners, to reach its full potential in the EU market, the official maintained.

Globally, Claris operates in more than 60 countries, through its subsidiaries, offices and marketing, distribution network, and a diverse customer profile covering institutions, major corporate hospitals and international aid agencies.