Complaint
| [Drug Name] | Human Fibrinogen | |
| [Excipients] | Sucrose | |
| [Appearance] | The product looks like a greyish-white or light yellow crisp cake. The reconstituted product shall be a clear liquid. Slight opalescence may occur. | |
| [Indications] | 30-min dry heat virus deactivation process under 100°C is newly added for the manufacture of the product, likely to cause a decrease of in vivo biological activity of human fibrinogen and change of immunogenicity, so it is recommended to use the product when there are no other effective therapies and it is required to supplement fibrinogen, and after weighing the pros and cons. | |
| 1. Congenital fibrinogenopenia or afibrinogenemia; | ||
| 2. Acquired fibrinogenopenia, severe liver impairment, liver cirrhosis; disseminated intravascular coagulation; and blood coagulation disorders due to afibrinogenemia caused by postpartum hemorrhage, major surgery, trauma, and internal hemorrhage. | ||
| [Specification] | 0.5g/vial | |
| [Storage] | Keep from sunlight under 2-8°C for storage and transport. | |
| [Package] | 1 vial (freeze drying)/pack, injection vial made of molded neutral borosilicate glass | |
| [Shelf Life] | 36 months | |
| [Applicable Standard] | Drug Registration Specification YBS00032008 and meeting the requirements of Chinese Pharmacopoeia (2020 Edition, Volume III). | |
| [Approval No.] | GYZZ S20013014 | |
Harbin Pacific Biopharmaceutical Co., Ltd. was established on August 26, 1986. It is the only blood product manufacturer in the three provinces in the northeast of China. It is located at 77 Siping Road, Limin Economical and Technological Development Zone, Harbin, covering an area of 97,000 square meters. The company has nine plasmapheresis stations in operation in Heilongjiang Province, nine plasmapheresis stations under construction and one plasmapheresis station in Sichuan province. The company's main business covers the production and sale of blood products, including human albumin, human immunoglobulin (pH4) for intravenous injection, human fibrinogen, totaling in three categories, nine varieties and twenty-nine specifications, with more than fifty independent intellectual property rights and nine invention patents.
The company has been recognized as "Post-Doctoral Research Center" by the Ministry of Human Resources and Social Security, "high-tech enterprise", "engineering technology center" by the Science and Technology Department of Heilongjiang Province, and "enterprise technology center" by the Department of Industry and Information Technology of Heilongjiang Province. In 1998, the company obtained the GMP certification of the National Medical Products Administration, and in 2003, it obtained the ISO9001 international quality system certification and IQNet certification. It has been awarded the following honors successively by relevant authorities at national, provincial and municipal level: "Little Giant Enterprise", "Asia's Most Influential Brand Award", "Private Science and Technology Enterprise Innovation Award in China", "Industry-University-Research Cooperation Innovation Award in China", "Heilongjiang Brand Unit", "Heilongjiang Science and Technology Innovation Demonstration Enterprise", "Provincial Advanced Grass-roots Party Organization", "Provincial Growth-oriented Non-public Enterprise Party Development Demonstration Site", and "Harbin Model Tax Payment Enterprise", as well as "Qualified Enterprise with Stable Quality" and "Contract-abiding and Credit-respecting Enterprise".
Since 2020, the company has donated 100,000 human immunoglobulin to the frontline health workers in Xiaogan, Hubei province and Heilongjiang Province through the provincial government. It is listed as the key pandemic prevention and control guarantee enterprises at both the state and Heilongjiang provincial level, as well as the asset energy reserve unit for pandemic combat supplies in Heilongjiang Province. It is listed in the pilot enterprises for pharmaceutical manufacturing monitoring of drugs in short supply at national level. Human tetanus immunoglobulin, human fibrinogen and human albumin developed by the company are listed in the catalogue of drugs in short supply at national level. The company undertakes the task of reservation for drugs in short supply at national level.
In consideration of the development trend of biomedical industry and blood products industry, the company is constantly researching and developing new products, such as freeze-dried human coagulation factor VIII preparation, human prothrombin complex, a new generation of intravenous immunoglobulin (10%, chromatography process), tetanus neutralizing monoclonal antibody, etc. Among them, the "Development of freeze-dried human coagulation factor VIII preparation" jointly declared with Harbin Institute of Technology has been listed as a major provincial science and technology project by the Science and Technology Department of Heilongjiang Province.
Harbin Pacific Biopharmaceutical Co., Ltd. takes root, blooms and bears fruit in the fertile land of Heilongjiang Province, adhering to the mission of transforming from "Made in China" to "Created in China", and strives to become a leading biopharmaceutical enterprise in Longjiang Biopharmaceutical.
The company has the world's production equipment introduced from Germany, the United States and other developed countries; With international production process; Equipped with blood products production line, the production process of the company's products is under the condition of full closure and automatic control.
