Differences between pharmaceutical intermediates and APIS

April 18, 2022

Both pharmaceutical intermediates and APIS belong to the category of Fine Chemicals. Intermediates are substances produced in the process steps of APIS that must undergo further molecular changes or refinement to become APIS, the intermediate may or may not separate.

Active Pharmaceutical Ingredient (API) : any substance or mixture of substances intended for use in the manufacture of pharmaceuticals and, when used in pharmaceutical manufacture, as an active ingredient in pharmaceuticals. The substance has pharmacological activity or other direct effects in the diagnosis, treatment, symptom relief, treatment, or prevention of disease, or may affect the function and structure of the body.

An API is an active product of a completed synthetic path, while an intermediate is a product somewhere in the synthetic path. The API can be prepared directly, while the intermediate can only be used to synthesize the next product, and only through the intermediate can the API be produced.

From the definition, it can be seen that the intermediate is the key product of the preceding process in the manufacture of the API, which is different from the structure of the API. In addition, the PHARMACOPOEIA has a method for the detection of API, but no intermediate. When it comes to certification, currently the FDA requires that intermediates be registered, not COS, but the CTD document contains a detailed process description of the intermediate. In China, there is no GMP mandatory requirement for intermediates.

Pharmaceutical intermediates, unlike bulk drugs, do not require production licenses, have relatively low barriers to entry and are highly competitive. Therefore, the quality, scale and management level are often the basis of the survival and development of enterprises, and the increasing pressure on environmental protection makes many small enterprises gradually withdraw from the stage of competition, industry concentration is expected to increase rapidly. It is generally believed that the following three directions will be relevant to enhance profitability, increase value-added, sustained growth of the key:

(1)Product diversification and high-end, from the production of extensive low-end intermediate to Fine high-end intermediate products;

(2)Take the road of professional outsourcing service, continue to extend in the outsourcing service industry chain, undertake R & D outsourcing services;

(3)Focus on pharmaceutical manufacturing and attack the APIS and preparations downstream from the intermediates.

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Author:

Ms. Yi

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