Synthgene News丨Jiangsu Provincial Food and Drug Administration Director Tian Feng investigates Synthgene


Release time:

2022-04-04

On the second day after the approval of Synthgene's SARS-CoV-2 antigen reagent, Director Tian Feng of the Provincial Food and Drug Administration led a team to Synthgene. for investigation. Chang Tongkun and others accompanied them to participate in the investigation.

On April 1, the SARS-CoV-2 (2019-nCoV) antigen detection kit (colloidal gold method) developed by  Synthgene was approved by the State Food and Drug Administration (Registration Certificate No.: National Machinery Note 20223400427).

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On the second day after the approval of  Synthgene's SARS-CoV-2 antigen reagent, Director Tian Feng of the Provincial Food and Drug Administration led a team to Nanjing Synthgene Medical Technology Co., Ltd. for investigation. Tongkun and others accompanied them to participate in the investigation. After visiting the company's production workshop, Dr. Tong Kun, chairman of  Synthgene, introduced the company's basic situation, research and development and production of SARS-CoV-2 antigen products, and company planning to Director Tian and his party. The research team gave relevant guidance on the production of SARS-CoV-2 antigen detection reagents.


Director Tian Feng said that antigen screening, as a supplement to nucleic acid testing, is an effective means of rapid discovery and preliminary diagnosis. The demand is large, and the company needs to increase production capacity as soon as possible to provide protection for epidemic prevention and control. At the same time, enterprises still need to strengthen quality management, earnestly fulfill their main responsibilities, and ensure the quality and safety of SARS-CoV-2 antigen detection reagents. The provincial drug administration department will fully support  Synthgene to expand production and supply, coordinate and solve the difficulties encountered by the enterprise in the production process, and effectively ensure the overall situation of epidemic prevention and control in the province.

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Guo Changbiao, deputy head of the district, said that he will further strengthen the connection with Synthgene, accelerate the implementation of Synthgene-related products and the transformation of achievements, and further promote the development of the pharmaceutical industry in Qixia District.

 

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At present, the global and Chinese epidemics are still spreading and showing new characteristics, and the challenges brought about by virus mutation are constant. Synthgene will always adhere to the corporate philosophy of "using technology to achieve health", and continue to make solid contributions to the prevention and control of the global SARS-CoV-2 epidemic!

 

Synthgene's SARS-CoV-2 (2019-nCoV) antigen detection kit (colloidal gold method) specification display

 

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