The National Development and Reform Commission, the Ministry of Finance, the Ministry of Health, and the Ministry of Industry and Information Technology have recently conducted a joint study on "special development of protein bio-pharmaceuticals and vaccines" and "general-purpose chemical drug development special projects". The review was completed in June 2012 and is expected to be introduced in July. It will also be supported by the central government financial funds together with the “Specialization of Industrial Revitalization and Technical Transformation†of the pharmaceutical industry.
Wang Xuegong introduced the development of protein biopharmaceuticals and vaccines to support the industrialization of biotechnology drug products and related industrial equipment and consumables. In terms of capacity-building for the industrialization of new products, it will promote the improvement of the levels of various links in the industry chain of bio-tech drug preparations and production process quality control, and promote the development of advantageous industrial chains; in terms of capacity building for the development of vaccines, the organization will implement the quality of the World Health Organization. System certification and product international registration, to achieve the domestic vaccine into the international market and the procurement system of relevant international organizations to form an international competitiveness. It will promote the industrialization capacity of supporting products and the construction of public service support capacity in the park.
The generic chemical drug development special project will support enterprises in the imitation of new-patented and patented drugs, establish basic platforms such as drug standards and trace impurities standards, and plans to support a number of formulation internationalization capacity-building projects, involving more than a dozen companies. enterprise. Promote the expansion of preparations in the international mainstream market, especially the market share of developed countries such as Europe, the United States and Japan.
In addition, in conjunction with the new GMP reform, through the “Industry Revitalization and Technical Reform Special Projectâ€, the GMP transformation of production companies including vaccines, Blood Products, sterile preparations, and essential medicines will be promoted, and chemical drugs, Chinese medicine, biological products, and medical care will be promoted. The industrialization of new products in the equipment field and the application of new technologies will focus on supporting varieties with potential demand and new drug certificates, mastering medical equipment for key components and key technologies, filling in new technologies in the domestic market, significantly improving the industry's technological level, and significantly reducing costs or New technologies to improve product quality.
Intravenous Injection Of Human Immunoglobulin
[Composition]
The main component of this preparation is human immunoglobulin, which is prepared by cold ethanol fractionation of human plasma from healthy donors. The manufacturing process contains a step to remove anticomplementary activity and a dual viral inactivation process. It contains a suitable amount of glucose or maltose as stabilizer (see table below), but does not contain any antiseptic or antibiotic. The distribution of IgG subclasses is close to the serum level of normal subjects and maintains the bioactivity of Fc fragment of IgG.
[Indications]
1. Primary
agammaglobulinemia, such as X-linked hypogammaglobulinemia,
common variant immunodeficiency diseases, immunoglobulin G subclass deficiency,
etc.
2. Secondary
immunoglobulin deficiency diseases, such as severe infection, septicemia of
newborn, etc
Intravenous Injection Of Human Immunoglobulin,Intravenous Immunoglobulin,High-Quality Effective Intravenous Immunoglobulin,Human Immunoglobulin For Intravenous Injection
Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd. , https://www.syimmunoglobulin.com