In May 2018, the Suzhou Food and Drug Administration carried out on-the-spot inspection of the drug production license application for Synermore(Suzhou). Three staff members of the Park Market Supervision Bureau participated as members of the inspection team was in the inspection. The inspection focuses on the implementation of units, factories, facilities, equipment, personnel and quality control documents. After investigation, Synermore(Suzhou) met the production and quality management requirements of existing varieties, and was approved and affirmed by the inspection team. In June 2018, Synermore(Suzhou) obtained the "Drug Production License".
Synermore(Suzhou) is positioned as "based on China, benefit the world", specializing in the research and development of monoclonal antibody drugs, production, adhere to the domestic and international product declaration at the same time, focusing on three major treatment areas of malignant tumors, autoimmune diseases, infectious diseases. The founder of the company, Dr. Tsao, is an expert in the field of bio-pharmaceutical research and development and production. He was awarded the 11th Science and Technology Leading Talents Project of Suzhou Industrial Park, and he is a "major leader" with many years of experience in the field of bio-pharmaceutical industry. The core management team headed by Dr. Tsao has many years of experience in the development of antibody drugs, process optimization, and so on. And they also have rich experience in production and quality management.
At present, Synermore has more than 10 products under study, 6 projects are in clinical research status, some varieties are about to carrying out phase III clinical application, so the "Drug Production License" for clinical trial sample production is in an urgent demand. Under the favorable environment of vigorously developing bio-pharmaceutical industry in the park, with the strong support of the Park leaders, Synermore(Suzhou) has been successfully got the license. Synermore is ready for the early realization of industrialization, and will create a good environment for development.