Company Profile
The two Production Plants of Shanghai Chemtron Biotech Co., Ltd. are located in the International Medical Park, Zhangjiang Development Zone, Pudong New District and Xiasha Town, Pudong New District in Shanghai. Chemtron was founded in January 2001, a high-tech enterprise in Shanghai, a vice president unit of the medical laboratory industry branch of the health industry management association, and a patent demonstration enterprise in Shanghai. Chemtron specializes in R & D, production, sales and services of in-vitro rapid detection of diagnostic reagents.
Chemtron has Production Plants over 17000 square meters with facilities for advanced R & D, production, quality inspection equipment and instruments of in-vitro diagnostic reagent with an annual production capacity of 320 million. In San Diego, California, the United States, Chemtron (U.S.) company has established a sole-owned product development center and production plant. At present, there are 194 employees, 110 with Bachelor’s degree or above including 3 Doctors, 10 Masters, accounting for 52.9% of the total employees of the company. In 2004, Chemtron passed the international certification of ISO13485 authoritative quality system; in March 2005, Chemtron passed the GMP certification of the State Food and drug administration; in 2009, it was listed in the biomedical industrialization project of Shanghai government; Chemtron’s main products obtained the CE certificate in EU; 12 drug testing products series have obtained the FDA certification of the United States.
Chemtron has established a first-class “Chemtron R & D technology center” in the United States and China. Based on the platform of monoclonal antibody technology and laboratory medicine technology, Chemtron has speeded up the R & D and marketing of its products. Chemtron has continuously developed and launched fast, sensitive, specific and accurate in-vitro diagnostic products. Chemtron now has a series of in-vitro diagnostic reagents under the national registered trademark "Chemtrue", with a total of 6 series of products of more than 40 varieties: such as drug detection; tumor detection; infectious disease detection; cardiovascular disease detection; hormone detection and POCT rapid quantitative intelligent instrument with supporting CRP, HCG, MAU, cTnI, myocardial infarction three-in-one, PCT, D2 polymer and other products.
Chemtron has always adhered to the business philosophy of "quality, reputation, service and sincerity" and the quality policy of "perfect quality, standardized management, innovation and sincere service". Chemtron’s products are sold to over 70 countries and regions around the world, such as the United States, Russia, Europe, South America, Middle East, East Asia, etc. Chemtron is willing to work together with you to relieve human suffering!
History
In 2001, Sino US joint venture Shanghai Chemtron Biotech Co., Ltd. was established.
In 2003, Chemtron's methamphetamine (Ice) test kit was rated as class A high tech achievement project in Shanghai.
In 2004, Chemtron passed the ISO13485 quality system international certification and China GMP certification. In the same year, Shanghai R & D center was established, gradually introducing the technology and high-quality raw materials of the US R & D center, and developing more products localized for China.
In 2005, for four consecutive years, Chemtron has been undertaking the production of national conscription physical examination reagent and drug detection reagent, the morphine / methamphetamine two-in-one test kit was designated by the Ministry of national defense for supply of products for conscription physical examination.
In 2007, Chemtron (US) was founded in San Diego, California. 13 products are FDA certified, 24 products are CE certified and 12 products are CLIA-waived certified.
In 2009, Chemtron undertake many major tasks from the Ministry and Health departments in China with supports from the State Science and Technology Commission in the R & D process.
In 2010, Chemtron’s annual production capacity reached 300 million, and products were sold to 98 countries and regions in Europe, the United States, Asia, Africa and the Middle East.
In 2011, Chemtron entered Shanghai Pudong International Medical Park, and four projects of immune quantitative diagnosis were supported by the innovation fund of the State and Shanghai Science and Technology Commission and the SME Technology Innovation Fund.
In 2012, the R & D of immunofluorescence quantitative and multichannel immunoquantitative analysis were launched, which enriched the POCT quantitative products series.
In 2013, Chemtron (US) successfully formed a reagent production plant and completed a substantive leap from R & D only to production, with product demand more suitable for European and American markets.
In 2014, a new products combination of reproductive health testing series and digestive tract testing series was released, and the reagent technology improvements made substantive progress.
In July 2014, Chemtron was awarded the title of "Three Star Integrity Enterprise";
October 2014, obtained the certificate of “High-Tech Enterprise”
In December 2015, the project “R & D of immunofluorescence chromatography rapid in-vitro diagnosis (POCT) product” (Project No. 12441900400 of Shanghai Science and Technology Commission) passed the acceptance.
In 2017, Shanghai Chemtron was rated as “IVD brand recognized by the examiner in 2017” and “Top 10 clinical immunoreagent brands recognized by the examiner in 2017”.
In 2018, Chemtron's “Chlamydia trachomatis antigen test kit” was rated as “Shanghai famous and excellent medical device product”.
In 2019, Chemtron's “Salmonella antigen detection kit” was awarded the gold medal in “Star of creation” 2018 excellent innovative products of in-vitro diagnostic reagents in China.
In November 2020,Chemtron successfully developed Chemtrue®COVID-19/Influenza A+B Ag Combo Rapid Test,and obtained CE certification.
In December 2020,Chemtron successfully developed Chemtrue® COVID-19/Influenza A+B/RSV Antigen Combo Rapid Test,and obtained CE certification.
In December 22,2020,Chemtron successfully developed Chemtrue® COVID-19/Influenza A+B/RSV/ADV Antigen Combo Rapid Test,and obtained CE certification.
In April 2021,Chemtrue® COVID-19（SARs-Cov-2）Antigen Rapid Test Kit(Saliva) and Chemtrue® COVID-19（SARs-Cov-2）Antigen Rapid Test Kit(Nasal Swab) was entered into the BfArM recommendation list of the German Federal Ministry of Health.
In June 2021,Chemtrue® COVID-19（SARs-Cov-2）Antigen Rapid Test Kit(Saliva) and Chemtrue® COVID-19（SARs-Cov-2）Antigen Rapid Test Kit(Nasal Swab) was entered into the BASG recommendation list of the Austrian Ministry of Health.
More new products such as LSD and XRL11-12 are in development and are coming soon.
Production Plant over 17000 square meters in International Medical Park, Pudong New District
Production Plant in Xiasha Town
Chemtron (U.S.) has established a sole-owned product development center and production plant in San Diego, California, the United States