Business
Savipharm receives EU GMP Certificate
  • | dtinews.vn | January 10, 2020 10:51 AM
Savi Pharmaceutical Joint Stock Company held a ceremony on January 9 to receive EU GMP certification and start construction on a new Savipharm High-tech R&D Centre.




Deputy head of Pharmacy Management Department, Do Van Dong presents EU GMP certification to Savipharm

Savi Pharmaceutical Joint Stock Company (SaVipharm) was founded in August 2005 by Doctor Tran Tuu, former General Director of Vietnam Pharmaceutical Corporation. Since its inception, the company has focused its resources to invest in an advanced Oral Solid Dosage (OSD) pharmaceutical plant. Investing in facilities for scientific research and R&D activities, including formulation research laboratories, pilots with equipment compatible with commercial production equipment; and quality control laboratories with all equipment imported from industrialised countries.




Doctor Tran Tuu, former General Director of Savipharm speaks at the event

With nearly 70 researchers selected and trained domestically and internationally, research and development in 12 pharmaceutical groups have produced nearly 200 high-quality products which have been approved for sale. Many pharmaceutical products manufactured by Savipharm have gradually replaced the imported varieties of the same type, contributing to Savipharm's high revenue growth rate over the years. Savipharm is one of the few pharmaceutical enterprises granted a Certificate of Science and Technology Enterprise by the prime minister with 178 recognised products.



Representatives of central agencies and leaders of Savipharm attend the ground breaking ceremony of a new Savipharm High-tech R&D Centre.

Immediately after the inauguration of OSD Factory, Savipharm became a pharmaceutical supplier for Glaxo Smith Kline (GSK) in the Asia Pacific, Japan and China. In April 2009, GSK transferred its entire Global Quality Policy and Quality Management Guide system to Savipharm to meet GSK standards. With the support of leading GSK experts, Savipharm has met high standards such as Japanese GMP, PIC/S GMP. The Japanese Pharmaceutical and Medical Device Agency (PMDA) - Ministry of Health of Japan audited and granted GMP certification to Savipharm firstly in December 2010 and then again in November 2017, paving the way to export pharmaceuticals to Japan since 2011, continuing to develop the exports of products to Malaysia, Cambodia.With the study of EU GMP standard system, Savipharm has conducted a comprehensive re-investment of all facilities, equipment, and infrastructure for OSD factory; adding high-tech equipment for quality control and R&D activities to meet European standards. From August 26-30, 2019, the European Community Competent Authority issued the EU GMP Certificate for Savipharm's Pharmaceutical Factory on November 28, 2019. SaVipharm's OSD Factory has achieved Japanese GMP and EU GMP pharmaceutical manufacture standards.




Director of HCM City Department of Science and Technology, Nguyen Viet Dung speaks at the event

Following the achievements in science and technology activities, Savipharm has set strategic goals for 2020-2025. Savipharm will continue to prioritise investment in human resources and science & technology and R&D activities, and invest in building a high-tech R&D Centre. The centre will research new and high technology product groups; receive and transfer new products and new technology; co-operate on research & development and new technology domestically and internationally; Organise research according to the new unit and topic group structure. The centre will receive investment in high-tech equipment such as formulation research laboratories, piloting and testing equipment and auxiliary systems. In addition, the OSD plantwill receive corresponding industrial production equipment, ensuring that the results of R&D activities at the centre are quickly put into commercial production following approval.

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