Phacogen Manufacturing Factory manufactures medical equipment and in vitro diagnostic (IVD) test kits for screening and diagnosing specialty groups such as cancer, infectious diseases, and obstetrics and gynecology. Phacogen Manufacturing Factory is invested in modern automatic production lines according to American and European standards with a capacity (phase 1) of 4 million test kits/year.
In addition to investing in modern technology based on a clean room system meeting ISO 8 standards, the conveyor, mixing, and sorting system uses automatic robots. The phacogen factory has also invested in a cold storage system with 24/7 automatic temperature monitoring to ensure that all products produced are continuously stored and preserved accurately. IVD diagnostic testing standards
Speaking at the ceremony, Mr. Duong Ngoc Cuong, Director of the Phacogen Manufacturing Factory said: "Pacogen is committed to producing high-quality test kit products at reasonable prices, helping to perfect existing testing solutions in the market, supporting medical facilities and testing centers to solve the supply problem, thereby improving the quality of health care for all Vietnamese people."
Dr. Duong Ngoc Cuong - Director of Phacogen Manufacturing Factory spoke at the Inauguration Ceremony
The Phacogen Manufacturing Factory has completed the construction of its facilities and successfully produced its first three products after an 18-month implementation period. The products are as follows:
- PCG® MagBead DNA Extraction Kit for extraction
- PCG® Sperm DNA Fragmentation Kit for testing sperm DNA integrity
- PCG® GBS Real-time PCR Kit for testing Group B Streptococcus qualitatively
In early June 2023, after a rigorous evaluation and inspection process from international organizations, TUV Rheinland (Germany) certified the Phacogen factory to meet international standards for medical equipment production under EN ISO 13485:2016. This certification makes Phacogen the only molecular biology test kit factory in Vietnam to have received this certification from TUV Rheinland to date.
Phacogen Manufacturing Factory director received EN ISO 13485:2016 certificate from TUV Rheinland representative
During the Inauguration Ceremony, the Phacogen Manufacturing Factory was officially awarded EN ISO 13485:2016 certification. The event also witnessed the signing ceremony of technology transfer and production cooperation between Phacogen Manufacturing Factory and Gene Laboratories, part of GC Group - the second-largest medical pharmaceutical group in Korea.
MOU signing ceremony between Phacogen Manufacturing Factory and Gene Laboratories, GC Group
Phacogen Manufacturing Factory's products are used for screening and diagnosing cancer markers, viruses, bacteria that cause infectious diseases, and abnormal factors in obstetrics and gynecology. These products have many outstanding advantages such as guaranteed quality and origin, tested by reputable organizations, competitive product prices, and especially the ability to promptly meet market needs. This is due to Phacogen's proactive approach in the entire process of product research and development, material optimization, testing, production, and quality control.
With such outstanding advantages, Phacogen's test kits are widely distributed domestically and have plans to be exported to the international market in the near future.
