Terapia Ranbaxy linked to EU norms

By Staff Reporter

- Last updated on GMT

Related tags Europe European union Eu

Ranbaxy has been granted an EU manufacturing and import license for
its Romania-based Terapia Ranbaxy subsidiary, and says it will make
the company a strategic regional hub for its operations in Europe.

Terapia Ranbaxy is the largest generic pharmaceutical company in Romania and approval for batch testing and release activities, following an assessment by the Romanian authorities last month, gives Ranbaxy a strong foothold in eastern Europe to mirror its established presence in the west of the continent.

The company will now be able to make medicines for sale in the EU, as well as carry out analytical testing that will allow products made outside the EU to be imported for sale.

Terapia Ranbaxy said it considers the green light a 'major event' in the evolution of the company, as its quality systems are now aligned with EU standards.

"It is the first and a very important step in the process whereby we are creating, in our site in Cluj-Napoca, a powerful platform for further expansion into the EU," said Dragos Damian, chief executive officer of Terapia Ranbaxy.

"The regulatory agency acknowledged the good systems and processes put in place in our Cluj-Napoca site and, at the same time, the quality of the laboratory and of the technology transfer."

Romania's pharmaceutical market is forecast to reach around $2.2bn (€1.67bn) in 2007, up from a level of around $945m in 2005, and Ranbaxy is looking to make Romania another hub for its European operations, having launched 15 products in 2005.

The Romanian market is expanding at a rate of about 34 per cent per annum, making it the fastest growing medicine market in Central and Eastern Europe.

Because of the large size of the market and the higher valuations of generics companies in the US compared to Europe, Indian pharma companies have been targeting European companies for acquisition.

Generic penetration in the EU has also been going up in recent years due to favourable regulatory changes.

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