The domestic pharmaceutical excipients industry started late, and there are many problems in scale, management regulations, and standard formulation. Recently, my country has studied and implemented the DMF (Drug Raw and Excipient Quality Master File Management) system to strengthen the raw materials, excipients, chemical intermediates, and chemical intermediates. Management of medicine packaging materials. The purpose of implementing DMF is to improve the current situation of the excipient industry, and at the same time, to drive preparation manufacturers to not only product quality, but also to go out and learn more about the entire production process and quality of their raw and excipient packaging materials, so that the quality of excipients will be greatly improved. The excipient industry is good news.　　 The international pharmaceutical market in the 21st century will be the world of new pharmaceutical preparations, and the advancement of preparations will surely promote the rapid development of the pharmaceutical excipients industry. The traditional role of pharmaceutical excipients is to help the release of the main drug ingredients, promote the dissolution of the main drug ingredients, or be used for some special purposes. Affected by the rapid development of bioengineering preparations, insoluble and insoluble pharmaceutical preparations, new dosage forms of Chinese medicine, the definition of pharmaceutical excipients has gradually changed. New antibodies or other new concept products have been included in the category of pharmaceutical excipients. The development prospects of the auxiliary materials industry are promising. To

　　 Facing the bright prospect of pharmaceutical excipients, industry standardization has become an inevitable trend. It is reported that domestic manufacturers of pharmaceutical excipients are mainly divided into specialized pharmaceutical excipient production enterprises (including foreign-funded excipient production enterprises), excipient production enterprises affiliated to pharmaceutical production enterprises, chemical raw material production enterprises, and food production enterprises. Most of these companies are small and medium-sized enterprises, and their R&D capabilities are relatively insufficient, making it difficult to form a capital agglomeration advantage. At present, there are more than 500 types of pharmaceutical excipients, and only 26.9% of them meet the medicinal standards; there are 187 types with approval number, accounting for 32% of the excipients; companies with pharmaceutical production licenses account for 19%, of which Chemical companies accounted for 45%, and food and other companies accounted for 36%. It can be seen that the concentration of the domestic pharmaceutical excipients industry is low, the industrial structure is unreasonable, and the enterprises are small and scattered. To

my country is studying the implementation of the DMF (Drug Raw Material Quality Master File Management) system. Some pharmaceutical excipient manufacturers with outdated production conditions will be eliminated. Through the DMF system norms and restrictions, companies will extend their production tentacles to the entire product quality formation process. Ensure the safety of medicines.