The API industry is facing new challenges. On the one hand, with the continuous improvement of international regulatory standards for APIs, API enterprises need to deal with strict and complex standards; on the other hand, with the increasingly strict requirements of the industry, API enterprises need to constantly improve the production quality. The industry pointed out that the quality and cost challenges of API will be more severe, forcing the industry to eliminate backward production capacity and promote the upgrading and transformation of enterprises.

Now, some API manufacturers are also trying to improve the level of quality management and production management by improving workflow, increasing automation and information technology. It is understood that the production process of API has experienced three stages: manual production, semi-automatic production and automatic production. With the continuous emergence of new pharmaceutical technologies and new drugs, the level of automation and informatization of production process is constantly improved, and the requirements of intelligent pharmaceutical industry are higher and higher. The API industry has entered a new stage of information and intelligent production.

Another advantage of realizing informatization and intelligence of API production is to meet the needs of green development of the industry. In January 2020, the four departments jointly issued the guiding opinions on promoting the green development of API industry. It is clear that by 2025, the industrial structure will be more reasonable, and the proportion of API produced by green process will be further increased; the technical level will be effectively improved, more than 20 green key generic technologies will be broken through, and the industry's green production technology will be basically replaced; green standards will be continuously improved and established Green factory, green park, green management standard evaluation system, etc. In the process of realizing information-based and intelligent production of API, it will also promote the industry to move towards the green direction.