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Promising prospects for pharmaceutical excipients

Promising prospects for pharmaceutical excipients

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 The domestic pharmaceutical excipients industry started late, and there are many problems in terms of scale, management regulations, and standards. Recently, China has researched and implemented the DMF (Main Quality Management of Pharmaceutical Raw Materials) system to strengthen APIs, excipients, chemical intermediates and Management of pharmaceutical packaging materials. The purpose of promoting DMF is to improve the status quo of the auxiliary materials industry, and at the same time drive the preparation manufacturers not only the product quality, but also must go out and learn more about the whole production process and quality of the raw and auxiliary materials packaging materials, so that the quality of the auxiliary materials will be greatly improved. The auxiliary industry is good news. The 21st century international pharmaceutical market will be the world of new pharmaceutical preparations, and the advancement of preparations will certainly promote the rapid development of the pharmaceutical excipient industry. The traditional role of pharmaceutical excipients is to help release the main ingredient, to promote the dissolution of the main ingredient, or for some specialized uses. Affected by the rapid development of preparations such as bioengineered preparations, insoluble and insoluble pharmaceutical preparations, and new dosage forms of traditional Chinese medicines, the definition of pharmaceutical excipients has gradually changed, and 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.

Faced with the bright prospects of pharmaceutical excipients, industry standardization has become an inevitable trend. It is reported that domestic enterprises producing pharmaceutical excipients are mainly divided into specialized pharmaceutical excipient production enterprises (including foreign auxiliary material production enterprises), excipient production enterprises, chemical raw material production enterprises and food production enterprises. Most of these enterprises are small and medium-sized enterprises, and their research and development strength is relatively insufficient, making it difficult to form a capital accumulation advantage. At present, there are more than 500 kinds of medicinal excipients, accounting for only 26.9% of the medicinal standards; 187 varieties with approval number, accounting for 32% of the auxiliaries; 19% of enterprises with pharmaceutical production licenses, including Chemical companies account for 45%, and food and other companies account for 36%. It can be seen that the concentration of domestic pharmaceutical excipients is low, the industrial structure is unreasonable, and the enterprises are scattered.
China's research and implementation of DMF (medical raw materials quality master file management) system, some production conditions behind the pharmaceutical excipients production enterprises will be eliminated, through the DMF system norms, the company will extend the production reach to the entire product quality formation process, thus The safety of the drug is guaranteed.