What are pharmaceutical intermediates? The difference between it and API!

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What is a pharmaceutical intermediate? The difference between him and API! Pharmaceutical intermediates and APIs belong to the category of fine chemicals. An intermediate is a material produced in the process steps of an API, which can only be made into an API through further molecular changes or refinement. The intermediate can be separated or not.
Active drug: Any substance or mixture of substances used in the manufacture of pharmaceutical products that, when used in pharmaceutical products, becomes the active substance of the pharmaceutical product. This substance has pharmacological or other direct effects in disease diagnosis, symptom relief, treatment, or disease prevention, or may affect the function and structure of the body. A drug is an active product that has completed a synthesis path, and an intermediate is a product somewhere in the synthesis path. Drug substances can be directly produced, while intermediates can only be used to synthesize the next product. Drug substances can only be produced through intermediates.
This definition indicates that intermediates are key products of the previous process of preparing APIs, and their structures are different from those of APIs. In addition, the pharmacopoeia contains methods for the detection of APIs, but there are no intermediates. As for certification, the FDA requires that intermediates be registered, not COS. However, the CTD document should contain a detailed process description of the intermediate. China has no mandatory GMP requirements for intermediates.
Pharmaceutical intermediates do not require production licenses such as APIs, and the entry threshold is relatively low, resulting in fierce competition. Therefore, quality, scale, and management level are often the basis for the survival and development of companies. The increasing pressure on environmental protection has also led many small companies to gradually withdraw from the competitive stage, and it is expected that the industry concentration will rapidly increase. It is generally believed that the following three directions will be the key for relevant companies to improve profitability, increase added value, and maintain growth:
(1) Product diversification, from large-scale production of low-end intermediates to fine intermediate production;
(2) Take the path of professional outsourcing services, further expand the outsourcing service industry chain, and take over R&D outsourcing services;
(3) Focus on pharmaceuticals and attack APIs and intermediates.

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