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IVIG

CAS number: 227945-81-5

Molecular formula: /

molecular weight: /

Chemical structure:

Producers shown on SFDA

(Record date:01/09/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Xi'an Huitian Blood Products Co., Ltd. 

GMP 
Valid till September 2022

Zhejiang Haikang Biotech Products Co., Ltd.

GMP 
Valid till June 2021

Zhengzhou RAAS Blood Products Co., Ltd.

GMP 
Valid till November 2023

Hualan Biological Engineering Chongqing Co., Ltd.

GMP 
Valid till September 2022

Harbin PAFC  Biopharmaceutical Co., Ltd.

GMP 
Valid till April 2024

Boya Bio-pharmaceutical Group Co., Ltd.

GMP 
Valid till July 2022

Shenzhen Weiguang Biological Products Co., Ltd.

GMP 
Valid till November 2023

Lanzhou Lansheng blood products Co., Ltd.

GMP Valid till June 2023

Shanxi Kangbao Biological Product Co., Ltd.

GMP 
Valid till October 2023

Shanghai Institute of Biological Products Co., Ltd.

GMP 
Valid till April 2018

Tonrol Bio-Pharmaceutical Co.,Ltd.

GMP 
Valid till May 2024

Shanghai Xinxing Medicine Co., Ltd.

GMP 
Valid till November 2023

Shanghai RAAS Blood Products Co., Ltd.

GMP 
Valid till November 2023

Guangdong Shuanglin Bio-pharmaceutical Co., Ltd.

GMP 
Valid till February 2024

Wuhan Zhong Yuan Rui De Biological Products Co., Ltd.

GMP 
Valid till February 2019

Shandong Taibang Biological Products Co., Ltd.

GMP 
Valid till February 2023

Sinopharm Group Wuhan Blood Products Co., Ltd.

GMP 
Valid till February 2022

 Green Cross (China) Biological Products Co., Ltd.

GMP 
Valid till December 2023

Guizhou Taibang Biological Products Co., Ltd.

GMP 
Valid till January 2024

Guangdong Wellen Pharmaceutical Co., Ltd.

GMP 
Valid till November 2024

Sinopharm Group Guizhou Blood Products Co., Ltd.

GMP 
Valid till November 2023

Nanyue Biopharming Corpration Ltd.

GMP 
Valid till April 2023

Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd.

GMP 
Valid till January 2019

Producers shown on EP

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Producer:Xi'an Huitian Blood Products Co., Ltd. (hereinafter referred to as Huitian company) was established in October 1996. It is the first batch of designated blood products production units in China and the only blood products production enterprise in Shaanxi Province. It is a Sino foreign joint venture blood products enterprise integrating scientific research, development, production and sales.

The company moved to Xi'an Modern Textile Industrial Park in 2014, covering an area of 26666.78 square meters and a greening area of 6500 square meters. The design and construction of the new plant are carried out in strict accordance with the requirements of GMP (2010 Edition) and the production process of blood products. Pipelining, automation, sealing and informatization run through the whole process of production process and operation, fully meet the production requirements of blood products, and are at the leading level in the same industry in China.

At present, Huitian company has 11 specifications of human albumin, intravenous human immunoglobulin (pH4), human immunoglobulin and hepatitis B human immunoglobulin. Among them, human albumin and intravenous human immunoglobulin (pH4) are listed as recommended products to the EU market by the French science and technology quality supervision and evaluation commission.

Staff size:100-199 persons

Registered capital:RMB 51 million


Producer:Zhejiang Haikang Biotech Products Co., Ltd. is the only high-tech enterprise producing blood products in Zhejiang Province. It is now a wholly-owned subsidiary of conch group. It passed the new version of national GMP certification in June 2016. The main products are: human albumin, intravenous human immunoglobulin, hepatitis B human immunoglobulin and intramuscular human immunoglobulin. Human albumin and intravenous human immunoglobulin are high-tech products in Zhejiang Province.

Staff size:50-99 persons

Registered capital:RMB 50 million


Producer:Zhengzhou RAAS Blood Products Co., Ltd. was founded in 1987 and now belongs to shanghai RAAS , covering an area of 70 mu and a plant construction area of 5400 square meters. The company has passed the national GMP certification. The company's products are mainly based on blood products. At present, the main products developed and produced by the company include human albumin, human immunoglobulin for intravenous injection Human immunoglobulin and other 3 series and 8 varieties.

Staff size:100-199 persons

Registered capital:RMB 100 million


Producer:Hualan Biological Engineering Chongqing Co., Ltd.(formerly known as Hualan Bioengineering Co., Ltd.) was established in 1992. It is a key high-tech enterprise engaged in the R & D and production of blood products, and is the first to pass the GMP certification in the blood products industry.

Hualan biological blood albumin, intravenous human immunoglobulin, human immunoglobulin, human prothrombin complex, surgical lyophilized human fibrin glue and other blood products with "Hualan" as the brand.

Staff size:500-599 persons

Registered capital:RMB 250 million


Producer:Zhengzhou RAAS Blood Products Co., Ltd.was established in 1986, covering an area of 110000 square meters and a construction area of 33526.9 square meters. It is an enterprise engaged in the production of blood products. The company has nine varieties and 29 specifications of products in three categories: human albumin, human immunoglobulin and coagulation factors.

The marketing network covers more than 30 domestic provinces, cities, autonomous regions and special administrative regions such as Hebei, Shandong, Henan and Hong Kong, as well as foreign sales markets such as India, Thailand and Yemen.

Staff size:200-299 persons

Registered capital:RMB 80 million 871 thousand and 606


Producer:Boya Bio-Pharmaceutical Group Co., Ltd., formerly known as Jiangxi Boya Bio-Pharmaceutical Co., Ltd., was founded in 1993. It is a comprehensive medical industry group focusing on blood products and integrating biochemical drugs, chemical drugs and API. Products include blood products, diabetes and anti infection chemical drugs, biochemical drugs, etc., has more than 90 varieties, nearly 200 specifications.

Staff size:About 2000 persons

Registered capital:RMB 433 million 300 thousand


Producer:Shenzhen Weiguang Biological Products Co., Ltd. is a national high-tech enterprise, the only blood product manufacturer in Shenzhen, and Guangming district is a state-controlled listed enterprise. Founded in 1985, the company is mainly engaged in the R & D, production and sales of blood products, including human albumin, intravenous human immunoglobulin (pH4), freeze-dried intravenous human immunoglobulin (pH4), human immunoglobulin, hepatitis B human immunoglobulin, rabies patient immunoglobulin, tetanus human immunoglobulin, histamine human immunoglobulin There are 9 varieties and 21 specifications of human fibrinogen.

The company has a talent team with strong stability and high professional and technical level, with a total of nearly 700 employees; It has a blood preparation production workshop with an investment of 350 million yuan and a production capacity of 500 tons of plasma.

Staff size:About 800 persons

Registered capital:RMB 226 million 800 thousand


Producer:Lanzhou Lansheng blood products Co., Ltd. is a state-owned enterprise, subordinate to China Biotechnology Co., Ltd., a subsidiary of China Pharmaceutical Group Co., Ltd. under the supervision of the state owned assets supervision and Administration Commission of the State Council. The company is mainly engaged in the R & D, manufacturing, sales and consulting services of blood products. It has industry-leading production technology and 10 product registration numbers such as "Lansheng" brand human serum albumin. Among them, human serum albumin and intravenous human immunoglobulin (pH4) are the basic products of the company. The products produced by the company are irreplaceable therapeutic biological products, which has a very special market position in the pharmaceutical industry. In the production process, the company has established a perfect quality assurance system, and all workshops have passed the GMP certification organized by the State Food and Drug Administration (CFDA).

Staff size:100-199 persons

Registered capital:RMB 13 million 577 thousand and 946


Producer:Shanxi Kangbao Biological Product Co., Ltd., founded in 1991, is a national key high-tech enterprise mainly engaged in the R & D and production of blood products, and passed the GMP certification of blood products enterprises in 1998. The company has strong development strength, leading technical level, first-class production and testing equipment Scientific and standardized operation and management and perfect quality assurance system.

The company has blood products, biopharmaceuticals, genetic engineering vaccines, chemical drugs and other varieties. While vigorously developing blood products, the company has also developed and produced API, small volume injection, lyophilized powder injection, tablet and oral liquid. All these workshops have passed GMP certification.

Staff size:700-799 persons

Registered capital:RMB 69.2 million


Producer:Founded in 1949, Shanghai Institute of Biological Products Co., Ltd. has a first-class blood preparation production line and a vaccine production building designed in accordance with EU GMP standards. All production workshops have passed the national GMP certification.

Over the past 20 years, more than 100 scientific and technological achievements have been made, of which more than 30 have won the national science and Technology Commission, the Ministry of health and provincial and municipal scientific and technological progress awards respectively, 8 products have won the title of new products in Shanghai, and some projects have won the first and second prizes of national scientific and technological progress awards. Over the past 60 years, Sinopharm Shanghai has maintained friendly exchanges and carried out technical exchanges and trade cooperation with more than 20 countries and regions such as the United States, the Netherlands, Japan, South Korea, Egypt, Brazil and Cuba.

Staff size:900-999 persons

Registered capital:RMB 2 billion 749 million 77 thousand and 751


Producer:Tonrol Bio-Pharmaceutical Co.,Ltd., is a national high-tech enterprise specializing in the R & D, production and sales of blood products. It is located at No. 376, Yanzihe Road, high tech Zone, Hefei, covering an area of 80 mu and a registered capital of 145 million yuan. The company passed the new national GMP certification in 2014 and is a designated national manufacturer of blood products.

Blood products are mainly bioactive preparations prepared from healthy human plasma by biological process or separation and purification technology, including albumin, immunoglobulin, various coagulation factors, etc. Blood products play an irreplaceable role in medical first aid and the prevention and treatment of some specific diseases. The company mainly produces blood products: human albumin, human immunoglobulin, intravenous human immunoglobulin (pH4), freeze-dried intravenous human immunoglobulin (pH4), hepatitis B human immunoglobulin, tetanus human immunoglobulin, rabies patient immunoglobulin and coagulation factor VIII. After years of development, the overall strength of the company ranks among the top four in China, and the production and sales of special products rank among the top in China. Now it has formed obvious brand, quality and management advantages.

Staff size:300-399 persons

Registered capital:RMB 145.35 million


Producer:Shanghai Xinxing Medicine Co., Ltd is now controlled and managed by China Medical and Health Industry Co., Ltd. the company is mainly engaged in the production and sales of blood products and the wholesale operation of other pharmaceutical products. With an investment of 170 million yuan and GMP certification, it has a first-class blood product production plant in Asia. At the same time, with GSP certified pharmaceutical sales department, it is a high-tech and export-oriented pharmaceutical group integrating scientific research, production, trade and investment.

The company's main products include various specifications of human albumin, intravenous human immunoglobulin (pH4), human prothrombin complex, human fibrinogen, hepatitis B human immunoglobulin, rabies patient immunoglobulin and human fibrin glue dispensing kits.

Staff size:100-199 persons

Registered capital:RMB 164 million


Producer:Shanghai RAAS Blood Products Co., Ltd., established in 1988 and listed on the small and medium-sized board of Shenzhen Stock Exchange in 2008, is a well-known blood products enterprise in Asia. Since its establishment 30 years ago, the company has been adhering to the quality policy of "safety, high quality and high efficiency", and has created 11 products covering three categories of blood products, human blood protein, human immunoglobulin and coagulation factors.

Shanghai Laishi has been registered in nearly 20 countries and is one of the few domestic manufacturers that can export blood products. Shanghai Laishi is produced in strict accordance with the requirements of GMP issued by the State Food and Drug Administration (SFDA). It is the first batch of blood products enterprises that have passed GMP certification in China, and complies with the regulations of the U.S. Food and Drug Administration (FDA), the guiding principles of the World Health Organization (who), the requirements of the U.S. Pharmacopoeia and the European Pharmacopoeia. In November 2000, the company successfully passed ISO9001 certification. It is the first blood product enterprise in China to pass ISO9001 quality system certification.

Staff size:About 3000 persons

Registered capital:RMB 6 billion 741 million


Producer:Founded in 1995,Guangdong Shuanglin Bio-pharmaceutical Co., Ltd. is the core enterprise of the listed company "Shuanglin biology". It is a high-tech enterprise integrating scientific research, development, production and sales of blood products. It is also a designated manufacturer of blood products that has passed the national GMP certification.

At present, the company mainly produces blood products of 17 specifications in 7 varieties, including 6 items listed in the provincial high-tech product catalogue, and has 16 drug approval numbers issued by the State Food and drug administration. It is one of the enterprises with high comprehensive utilization rate of plasma, complete varieties and reasonable structure in the same industry in China. Intravenous human immunoglobulin (pH4) is a product of the national "key Torch Program".

 Staff size:300-399 persons

Registered capital:RMB 1039.6 million


Producer:Wuhan Zhong Yuan Rui De Biological Products Co., Ltd.is now subordinate to CSL Behring.

It is a high-tech enterprise integrating R & D, production and operation of blood products. It is committed to developing, producing and selling plasma products for China's domestic market, including albumin, intravenous human immunoglobulin and special immunoglobulin products. The company also has a coagulation factor product line in the later stage of R & D, and plans to launch multiple coagulation factor products including eight factors in the next few years.

Staff size:200-299 persons

Registered capital:RMB 741 million 592 thousand and 721


Producer:Shandong Taibang Biological Products Co., Ltd. is a joint venture established in November 2002 between Shandong Institute of biological products and foreign investors. The company has a product line of blood products with more than 20 specifications covering three categories of albumin, immunoglobulin and coagulation factors.

There are 9 varieties and 24 specifications of products, including human albumin, human immunoglobulin, intravenous human immunoglobulin (pH4), hepatitis B human immunoglobulin, rabies patient immunoglobulin, tetanus human immunoglobulin, human coagulation factor VIII, human prothrombin complex and human fibrinogen. The qualified rate of product batch issuance is 100%, High quality products have won the favor of the market.

Staff size:RMB 160 million

Registered capital:600-699 persons


For supply and market information, please feel free to contact Mr. Paul, paulzhang@yinuopharmchem.com, WhatsApp: +86 18402846978