In line with Ranbaxy's plan to transform Terapia-Ranbaxy into a strategic regional hub for its operations in Europe, the largest generics pharmaceutical company in Romania, has received the manufacturing and import authorisation according to the European Union (EU) norms and standards.
Following the inspection, conducted at the beginning of February by the Romanian Regulatory Agency, Terapia-Ranbaxy has been given the go ahead for batch testing and release activities for products manufactured outside EU.
"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. Under these circumstances, Terapia-Ranbaxy has become the first pharmaceutical company authorized to do batch testing and releasing in Romania. The company's laboratory is the 4th laboratory of its kind in Romania," said Dragos Damian, CEO Terapia-Ranbaxy. The Regulatory Agency commended the professionalism and commitment of the Terapia-Ranbaxy's employees involved in the process, company release stated.
Referring to the importance of the development, Cornelia Pop, Terapia-Ranbaxy QA manager said, "When it comes to quality systems, our company is an initiator and a starter in the market." Recalling a similar moment in the company's history. In December 1999, Terapia has received the first Good Manufacturing Practice Certificate given in Romania by the National Agency of Medicine for pharmaceutical products of human use."
This authorization is a major event in the company's evolution as it aligns the quality systems in Terapia-Ranbaxy with the EU norms. Additionally, it also synchronizes these with the systems at parent company, Ranbaxy. "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 Damian.
The company is undergoing a successful integration process including re-branding, increasing and training the commercial force. For 2007, the company is planning to launch more than 40 new products.