A solemn ceremony was held by Vietnamese pharmaceutical firm SaVipharm in Ho Chi Minh City on Thursday to receive a European Union Good Manufacturing Practice (GMP) certificate as well as breaking ground on the firm’s new high-tech R&D center.
It was SaVipharm’s third GMP certification in accordance with EU standards for its Oral Solid Dosage (OSD) factory.
SaVi Pharmaceutical Joint Stock Company (SaVipharm) was founded in August 2005 by Meritorious Doctor, Pharmacist Specialist II Tran Tuu, former General Director of the Vietnam Pharmaceutical Corporation.
|Meritorious Doctor, Pharmacist Specialist II Tran Tuu, Chairman and General Director of SaVipharm, speaks at a ceremony to receive the firm’s EU Good Manufacturing Practice certificate in Ho Chi Minh City on January 7, 2020. Photo: SaVipharm|
Since its inception, the company has focused its resources on investing in its OSD factory with synchronous and modern production lines and equipment and new technologies managed by the SCADA system, investing in facilities for scientific research and R&D activities, including formulation research laboratories and pilots with equipment compatible with commercial production equipment, and operating quality control laboratories with all equipment imported from industrialized countries.
It is one of a few pharmaceutical enterprises in Vietnam to have been granted the Certificate of Science and Technology Enterprise by the Ho Chi Minh City Department of Science and Technology, thanks to its 178 recognized products.
|Dr. Truong Quoc Cuong, Deputy Minister of Health, speaks at a ceremony granting SaVipharm an EU Good Manufacturing Practice certificate in Ho Chi Minh City on January 7, 2020. Photo: SaVipharm|
A GMP certification describes the minimum standard that pharmaceutical companies must meet in their production processes, according to the European Medicines Agency, the organization responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU.
The EU GMP certification, the highest recognition available to companies in the pharmaceutical space, was issued to SaVipharm by the European Community Competent Authority on November 28, 2019 after they conducted an inspection at the Vietnamese pharmaceutical firm’s OSD factory from August 26 to 30 the same year.
|Dr. Nguyen Viet Dung, director of the Ho Chi Minh City Department of Science and Technology, speaks at a ceremony granting SaVipharm an EU Good Manufacturing Practice certificate in Ho Chi Minh City on January 7, 2020. Photo: SaVipharm|
This is the third GMP certification SaVipharm has received, following the two it was granted by the Pharmaceutical and Medical Device Agency under the Ministry of Health of Japan in December 2010 and November 2017.
SaVipharm announced that these two certifications have paved the way for it to export a group of medications to Japan since 2011 and continue to develop the exportation of this group of products to Malaysia, Cambodia, and other markets.
At the ceremony honoring the EU GMP certification on Thursday, the company also broke ground on the construction of its high-tech R&D center at the Tan Thuan Export Processing Zone in District 7, Ho Chi Minh City.
|Officials and SaVipharm leaders take part in a groundbreaking ritual for the firm’s new high-tech research and development center in Ho Chi Minh City on January 7, 2020. Photo: SaVipharm|
The center operates with key objectives including researching new and high technology product groups, receiving and transferring new products and new technology, coordinating domestic and international cooperation in scientific research and R&D, and organizing a research system according to the new structure which focuses on units and topic groups.
The R&D center is being invested with synchronous and high-tech equipment, including formulation research laboratories, pilots, testing equipment, and auxiliary systems.
In addition to the equipment of the center, the OSD factory will be invested with the corresponding industrial production equipment, ensuring that the results of R&D activities at the center are quickly put into commercial production after being approved.
The center is built to research new and high technology product groups, receive and transfer new products and technologies, promote domestic and international cooperation in scientific research and R&D, and organize the research system according to a new structure, SaVipharm said.