Terapia Ranbaxy's Bucharest site gets GMP nod
The Bucharest-based production facility of Terapia Ranbaxy has received a renewal of certification for Good Manufacturing Practice standards at the operational level by the National Agency of Medicine.
MUMBAI: The Bucharest-based production facility of Terapia Ranbaxy has received a renewal of certification for Good Manufacturing Practice standards at the operational level by the National Agency of Medicine.
"At the Bucharest site, we manufacture over 60 products comprising liquids and solids. We have more than 100 highly qualified specialists working at this site who have worked to very high standards and have cooperated extremely well with the Quality Assurance Department to get this important certification," Terapia Ranbaxy CEO Dragos Damian said.
The inspection was carried out within the procedural three years time frame and ended-up with the release of the authorisation for another three years, Ranbaxy informed the Bombay Stock Exchange.
The Bucharest site became a part of Terapia Ranbaxy in August 2005.
Following the inspection by the Romanian Regulatory Agency, Terapia Ranbaxy was granted the green light for batch testing and release activities for products manufactured outside the European Union.
The manufacturing operations of the company are also acknowledged as being in full accordance with the EU norms and regulations.
The company is ongoing an integration process including re-branding, increasing and training the commercial force. It is also planning to commercially launch more than 40 new products this year.
Last June, Ranbaxy acquired 96.7 per cent of the Romanian generics company Terapia SA.
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