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/Nanjing Norman Can Produce 3 Million Doses of Novel Coronavirus (PEI) Reagents Per Day
Nanjing Norman Can Produce 3 Million Doses of Novel Coronavirus (PEI) Reagents Per Day
April 22, 2021

Nanjing Norman Can Produce 3 Million Doses of Novel Coronavirus (PEI) Reagents Per Day

Facing the repeated ravages of COVID-19 in Europe, rapid antigen detection, as a fast and convenient novel coronavirus detection method, has been one of the main methods used by many countries and organizations for the test of early infected people. Following the admittance of self-testing in German, in order to encourage everyone to do self-testing twice a week, the British government will introduce the plan of free self-testing for all citizens formally.

Therefore, everyone in England will receive the twice-weekly rapid test of COVID-19. This is a huge expansion of the government’s massive asymptomatic testing plan. Then the European countries will encourage self-testing one by one, resulting to concentration outbreak of market needs. Countless orders hit those Chinese companies which have obtained PEI. While Chinese IVD companies are bothering about their poor production capacity of Colloidal gold. Most of them just have small scale of clean area factory, less than 500 square meters. Only a few large-sized enterprises like Nanjing Norman have daily capacity of million doses.

To ensure over 100 million people per month’s production capacity, first, the upstream raw materials should be sufficient; second, the production GMP workshop must be at least 3000 square meters and equipped with fully automatic assembly lines; finally, government’s support to ensure enough production workers. Nanjing Norman Biological Technology Co., LTD., founded in 2008, is one of the leading enterprises in the field of Automatic chemiluminescence in China. It is the company with the fastest development of POCT rapid diagnostic reagents, one of the few domestic in vitro diagnostic industry that has both antigens, antibodies, and reagents, and one of the enterprises with the ability of R&D, production and sales of products such as, instruments and so on. Its advantages lie in its strong R&D capabilities, self-produced raw materials, and national using certificate of testing mouse.

The factory area of the company is 31,000 square meters with four floors of 100,000-grade GMP clean production area. Norman have a strong quality control system from raw material, such as automatic inner packaging material cleaning line, automatic film sticking machine, automatic scribing machine, automatic gold spraying instrument and so on, to ensure the timeliness of shipment with fully automated production.

Professional version has been completely exported to Germany, Czech Republic, Holland, France and other medical institutions. Norman Also will obtain the BfArM self-testing certificate in the coming future, then the approval will be added to the self-testing list.

Novel Coronavirus (2019-nCoV) Antigen Testing Kit has previously obtained EU CE certification (for professional use), and can be sold in EU countries and countries that recognize EU CE certification.

Chuzhou City of Anhui Province is the back garden of Nanjing Jiangbei New District, 5 kilometers away from Nanjing Norman. With a large number of migrant workers from Anhui province and the support of the local government, Norman obtained a large number of production workers and promoted a large number of local employment. Norman have four workshops that can produce 3 million to 5 million testing kit per day, monthly production can be over hundreds of millions.

At present, Norman mainly produces these products:

The product type

Sampling methods

The main purpose

Novel Coronavirus antigen detection reagent

Nasopharyngeal swabs, anterior nasal cavity, saliva

Early screening and early diagnosis are suitable for large-scale rapid screening

Novel Coronavirus IgM/IgG antibody detection reagent

Tip of the finger blood

It is suitable for the detection of large number of suspected cases and asymptomatic infected people

Novel Coronavirus neutralizing antibody detection reagent

Tip of the finger blood

It is suitable for the detection and evaluation of vaccine effect after the injection of COVID-19 vaccine

Reagents for triple detection of COVID-A-B antigen

Nasopharyngeal swabs

It is suitable for detection of influenza in the high incidence period, to identify influenza and novel coronavirus infection, and to guide the formulation of diagnosis and treatment

The production capacity of top five companies in China' are already full, only Norman currently has spare capacity to accept global OEM orders.

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