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The Development Course of Shanghai Rong Sheng Biopharmaceutical Co., Ltd.

In October 1988, "Shanghai Rong Sheng biochemical reagent Factory" was established at No.185 Huajing Road, Shanghai, with a capital of 15, yuan and 8 employees.

in November, 1989, the first product in Rong Sheng, the surface kit for detecting hepatitis B by hemagglutination, came out.

In June, 199, Rong Sheng passed the first batch of rectification and acceptance of diagnostic reagent enterprises by the Ministry of Health, and obtained the Certificate of Pharmaceutical Production Possibility.

in may, 1994, Rong Sheng introduced the replacement "TRUST" card kit.

In June, 1995, Shanghai Rong Sheng Biotechnology Co., Ltd., which was established according to the new Company Law, was formally established at No.99 Huafa Road, Shanghai, and its capital was expanded to 26 million yuan.

In July, 1995, Rong Sheng introduced the ELISA kit for detecting hepatitis B virus and anti-HCV by "immediately knowing" EIA method.

In June, 1996, Rong Sheng passed the evaluation of Shanghai Science and Technology Commission and became the first batch of "Shanghai High-tech Enterprises".

In May, 1998, the patent of "Comb Dot Immunoassay Box" was approved, with the patent number of ZL97 2 34216.8.

in October, 1998, the 1th anniversary of the founding of Rong Sheng, the scale developed to: 2,5m2 factory building (including 5m2 in purification workshop), capital of 36 million yuan, 71 employees, more than 4 kinds of products, and the output value of that year exceeded 6 million yuan.

in June, 2, Rong Sheng cooperated with the United States to launch the special biochemical reagent (on-board reagent) for BIORESUN series automatic biochemical analyzer.

In October, 21, Rong Sheng successfully passed the ISO92 quality system certification of the company by NSF international consulting and certification organization of the United States, and obtained the export license.

in January, 22, Rong Sheng factory successfully passed the "good manufacturing practice (GMP)" certification of China State Food and Drug Administration at one time, setting a new milestone for Rongsheng.

in August, 22, the fourth generation "semi-automatic, general automatic liquid single reagent for biochemical instrument" of Rong Sheng International was newly launched.

In December, 22, Rong Sheng formally established the "Rong Sheng Technology Center" and hired Chinese-American scientists as the directors of the company's CSO and technology center, making R&D personnel account for 2% of the company's total employees.

in March, 23, Rong Sheng founded a quarterly magazine, Rongshengchao, to look at the whole industry from the perspective of an enterprise and lead an industry with a unique style.

in October p>23, the quality management system of Rong Sheng ISO92 was successfully upgraded to ISO91:2.

In December, 23, Rong Sheng, together with the National Health Industry Enterprise Management Association, China Medical Laboratory Branch, Clinical Laboratory Center of the Ministry of Health and Health Newspaper, successfully held the first "Rong Sheng Cup" China Laboratory Medicine Knowledge Competition.

In March, 24, the first "two-and-a-half" hepatitis B kit with one-year validity was launched in China.

in may p>24, the production of HIV(1+2) in Rong Sheng passed the GMP (good manufacturing practice) certification successfully, and the company obtained the second GMP certification.

in July, 24, as the first significant achievement since the establishment of the company's technology center, the potassium and sodium enzyme kit was successfully developed and put into production. AFU, GPDA, 5'-NT and ADA kits were successfully developed.

in October, 24, it was awarded the 23 Contract Credit Enterprise Certificate issued by Shanghai Administration for Industry and Commerce and the 23 Contract Credit Rating AAA Certificate issued by Shanghai Contract Credit Promotion Association.

in December, 24, the quality management system of biochemical reagent production in Rong Sheng passed the examination and acceptance of the quality management system of medical device manufacturing enterprises of Shanghai Food and Drug Administration, and obtained the quality system examination report of medical device manufacturing enterprises.

in August, 25, the packaging specifications of HCV were increased by 48 persons and 576 persons, and the product was upgraded to a one-year validity period.

in October, 25, the number of HIV patients increased by 48 and 576, with one-year validity. 48 copies of HCV and 576 copies of HBV were officially put into production. 96 copies of HIV were used as physical examination reagents in nearly 2 provinces for national winter conscription. The registration certificate of biochemical products has completed the transition from trial production to quasi-production The number of medical device registration certificates reached 54.

in February, 26, the patent of "enzyme-labeled plate with adsorption" was approved, and the patent number was ZL 24 2 11449..

in April, 26, the diagnostic kits of HAV-IgM and HBcAb-IgM (enzyme-linked immunosorbent assay) were increased by 96 people, with one-year validity. The original "trial" production registered products have become quasi-production registered products. Hepatitis B virus surface antibody, surface antigen diagnostic kit and syphilis toluidine red unheated serum test diagnostic kit were awarded the certificate of "25 Famous Product" in Shanghai pharmaceutical industry.

in August, 26, the reagent and method for enzymatic determination of serum potassium and sodium ions "invention patent passed the examination of China National Intellectual Property Administration (application numbers 261284511 and 261284526)". Rong Sheng Company was awarded the 24-25 certificate of abiding by contracts and valuing credit by Shanghai Administration for Industry and Commerce, and the 24-25 AAA certificate of contract credit rating by Shanghai Contract Credit Promotion Association.

In November, 26, "Rong Sheng" brand in vitro diagnostic reagent was recommended as "Brand Product of 26" by Shanghai SME Brand Building Promotion Committee.

in January p>27, the HIV antibody diagnostic kit won the second place in the national quality evaluation in 26.

in July, 27, the new biological site in Rong Sheng was completed: a 5-mu garden-style factory with a building area of 35, square meters, a GMP workshop with more than 1, square meters, a special quality control technology building and an experimental animal center.

In August, 27, Rong Sheng Company was awarded the certificate of "Integrity Unit of Labor and Social Security" by Shanghai Xuhui District Labor Association.

in October p>27, it was awarded the AAA certificate of 26 contract credit rating by Shanghai Contract Credit Promotion Association.

in December p>27, it was awarded the certificate of "Excellent Innovative Enterprise" and "Honest Enterprise" in Shanghai biomedical industry.

in January, 28, Rong Sheng successfully passed the relocation and obtained the GMP certificate of the new factory. The HIV antibody diagnostic kit won the first place in the national quality evaluation in 27.

in September p>28, the new name of "Shanghai Rong Sheng Bio-pharmaceutical Co., Ltd." was launched.

in October p>28, it was awarded the AAA certificate of 27 contract credit rating by Shanghai Contract Credit Promotion Association. Certificate of 26-27 Contract-abiding and Credit-abiding Enterprise issued by Shanghai Administration for Industry and Commerce.

In November, 28, "Rong Sheng" brand in vitro diagnostic reagent was recommended as "Brand Product of 28" by Shanghai SME Brand Building Promotion Committee.

in January p>29, Rong Sheng trademark was recognized as "Shanghai Famous Trademark" by Shanghai Administration for Industry and Commerce.