It is imperative for the high quality development of pharmaceutical excipients to accelerate the upgrading of the industry

[pharmaceutical Station industry trends] pharmaceutical excipients are the basic materials and important components of pharmaceutical preparations, which play a key role in the formulation and production In recent years, with the continuous standardization of the pharmaceutical excipients market and the continuous improvement of industry standards, the country's attention to this is constantly increasing, and the pharmaceutical excipients industry ushers in a good opportunity for development Industry data shows that in 2017, the market scale of pharmaceutical excipients in China is about 119.3 billion yuan According to the data that the global pharmaceutical excipients market is expected to reach 85.3 billion US dollars in 2023, the pharmaceutical excipients industry in China will have a better market space in the future Under the background that the country strongly supports the pharmaceutical excipients industry and API advocates green development, the high-quality development of pharmaceutical excipients is imperative On the one hand, the pharmaceutical excipients industry has been paid more and more attention, and the industry has been standardized Among them, the key basic role of pharmaceutical excipients in the field of drug development is defined in the released development plan of biological industry According to the Pharmacopoeia 2020, the inclusion of standards for raw materials, Chinese herbal medicines and pharmaceutical excipients will be emphasized It is clearly proposed in the draft for comments to further strengthen and improve the pharmacopoeia standard system for pharmaceutical excipients and drug packaging materials, increase the collection of standards for commonly used pharmaceutical excipients and drug packaging materials, promote the collection of mature standards for new pharmaceutical excipients and drug packaging materials, focus on strengthening the formulation of excipients for high-risk preparations (injection, eye preparation, inhalation preparation and animal source); promote the collection of pharmaceutical excipients And the renewal of drug packaging materials In addition, in order to further standardize the nomenclature of pharmaceutical excipients, the publication of the principles for nomenclature of pharmaceutical excipients in China (Draft for comments) means that the registration of pharmaceutical excipients in China has been officially reformed from the independent review and approval (approval number management) to the management mode of related review and approval On the other hand, China's pharmaceutical excipients industry, after years of development, although gradually moving towards the direction of standardization, but at present, the overall level of the industry is not high In the context of rapid market expansion, the phenomenon of "small disorder" in the industry is obvious, which seriously restricts the further development of the industry, and there is still a distance from the mature stage of the market The industry believes that the development of pharmaceutical excipients industry is still facing many challenges For example, at present, there are more than 540 kinds of pharmaceutical excipients in use in China, and the standards of excipients in Pharmacopoeia are increasing, but compared with the United States and European countries, the quantity and standard quantity are quite different In addition, many new pharmaceutical excipients are only used abroad and not registered in China Therefore, the number of varieties and specifications of the pharmaceutical excipients industry in China need to be explored Secondly, compared with foreign countries, the quality standard of bulk pharmaceutical excipients in China is not small, and the complex and new pharmaceutical excipients have strong import dependence Therefore, the new excipients need to be researched and developed to further realize import substitution Third, the production technology of domestic pharmaceutical auxiliary materials enterprises is not mature enough, and the enterprises are still lack of investment in research and development and management Fourthly, the development of domestic pharmaceutical excipients industry is unbalanced, most of the products are in the low-end market, and the supply of medium and high-quality products with complex technology is insufficient With China's pharmaceutical excipients industry gradually entering the development period, the scale continues to expand, the industry continues to standardize, the industry will accelerate the transformation and upgrading, the domestic excipients industry is imperative to integrate with the international, and the R & D innovation and quality requirements will continue to improve.