Terapia Ranbaxy receives GMP Certificate renewal

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Terapia Ranbaxy receives GMP Certificate renewal

Terapia Ranbaxy receives GMP Certificate renewal from National Agency of Medicine for Bucharest site

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Following an inspection conducted by the National Agency of Medicine, the Bucharest based production facility of Terapia Ranbaxy has received a renewal of certification for Good Manufacturing Practice standards at the operational level. The inspection was carried out within the procedural three years time frame and ended-up with the release of the authorization for another three years.

"At the Bucharest site, we manufacture over 60 products comprising liquids (drops, syrups and ophthalmic solutions) 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", said Dragos Damian, CEO Terapia Ranbaxy. The Bucharest site became a part of Terapia Ranbaxy in August 2005, when Terapia acquired the Promedic and Pharmaplant facilities.

Last month, the company received the Manufacturing and Import Authorization. Following the inspection, conducted at the beginning of February 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. At the same time, the manufacturing operations of the company are acknowledged as being in full accordance with the EU norms and regulations.

Explaining the process, Cornelia Pop QA Manager said: "Last month, the Regulatory Body gave us the Manufacturing and Import Authorization that represent an alignment of the quality system certificates that were owned by the company based on previous inspections. Now we are talking about a renewal of the basic certificates."

"This Certificate is a proof that Terapia Ranbaxy meets the European Standards. The quality standards recognition is another clear sign that the integration process is successfully completed in most areas, bringing added value to the company" added Damian.

In November last year, Terapia Ranbaxy announced completion of the investment in a new logistic center in Otopeni - Bucharest. The investment's were aimed at increasing the Company's warehousing space for all products included in the Terapia Ranbaxy portfolioincluding customs bonded warehouse services for the products produced by Ranbaxy and imported from India.

The Company is ongoing a successful integration process including re-branding, increasing and training the commercial force, The Company is planning to commercially launch more than 40 new products in 2007.

Last June, Ranbaxy Laboratories Ltd . announced the completion of the acquisition process by Ranbaxy Netherlands BV of 96.7% of the top Romanian generics company Terapia SA . The combined operations of Terapia Ranbaxy have established the largest Romanian generics company. The commercial name of the company is Terapia Ranbaxy. With a market share of 5.6%, Terapia Ranbaxy registered in 2006 an increase of its turnover of almost 50% against 2005.

Established in 1921, Terapia has a strong brand name and a consistent track record of growth and profitability. The company is well placed to benefit from the strong growth Romania will experience in the coming years as healthcare spending will move up to the levels of other Central European Countries.

Sourced From: Ranbaxy Laboratories Ltd