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https://www.aolisenchem.com/pharmaceutical-intermediates.html

As one of the best pharmaceutical ingredients manufacturers and active pharmaceutical ingredient manufacturers from China, Aolisenchem has continuously improved the core competitiveness of chemical intermediates production technology, which is specifically reflected in the choice of chemical reaction process, process control, the choice of core catalysts and so on, strive to improve the production efficiency and product quality of the enterprise, continue to innovate independently, and expand various unit reaction processes.

1. Definition of pharmaceutical intermediates and APIs
Both pharmaceutical intermediates and APIs belong to the category of fine chemicals. Intermediates are produced in API process steps and must undergo further molecular changes or refinement to become a material of APIs. Intermediates can be separated or not separated.

API medicines: Any substance or mixture of substances intended to be used in the manufacture of medicines, and when used in medicine, it becomes an active ingredient of medicines.

2. The difference between pharmaceutical intermediates and APIs
The bulk drug is an active product that has completed the synthetic route, and the intermediate is a product in a certain place in the synthetic route. The API can be directly formulated, and the intermediate can only be used to synthesize the next product. Only through the intermediate can the API be manufactured.

Pharmaceutical intermediates are the key products of the previous process of making APIs, which are different in structure from APIs. In addition, the pharmacopoeia has testing methods for APIs, but no intermediates. Speaking of certification, the FDA currently requires that intermediates must be registered, while COS does not, but the CTD file must have a detailed process description of the intermediate.

Pharmaceutical intermediates do not require production licenses like APIs, and the barriers to entry are relatively low and competition is fierce. Therefore, quality, scale, and management level are often the foundation for the survival and development of enterprises, and the increasing pressure on environmental protection has caused many small enterprises to gradually withdraw from the competition arena, and industry concentration is expected to increase rapidly.