The Specific Difference between API and Intermediates



You may have heard about API and Intermediates, but do you know the difference between them? We will show them in this blog.

You may have heard about API and Intermediates, but do you know the difference between them? We will show them in this blog.


First, the different definitions


Materials produced in the API process steps that must undergo further molecular changes or refinement to become APIs. They do not require a drug manufacturing license and can be produced in ordinary chemical plants and used in the synthesis of drugs as long as they reach a certain level.

Active Pharmaceutical Ingredient (API)
Any substance or mixture of substances intended for use in the manufacture of a drug that, when used in pharmaceuticals, becomes the active ingredient of the drug. The substance has pharmacological activity or other direct effects in the diagnosis, treatment, relief of symptoms, control or prevention of disease, or can affect the function and structure of the body.
As can be seen from the definition, intermediates are key products in the pre-process of making APIs and have a different structure than APIs. In addition, the pharmacopoeia has the test method of API, but no intermediates.

Second, therapeutic effect

From the perspective of new drug development, API refers to the compound that can be safely used in the human body for treatment and diagnosis after adequate pharmacological studies; while intermediates are compounds in the process of synthesizing APIs, which do not necessarily have therapeutic effects and toxicity. Note that here is not necessarily, some API synthesis process intermediates are also APIs.


Third, approval

From the perspective of drug management, APIs should apply for registration with the drug regulatory authorities according to the law and obtain an approval number to be synthesized in a factory that meets GMP requirements; while intermediates are only intermediates in the process of synthesizing APIs and do not need to obtain a number. It should be noted that the same compound as the API does not obtain a registration number or not produced in a GMP plant are not APIs.




Fourth, the connection

1, Specific substances are different
Pharmaceutical intermediate is a semi-finished product, a product for the production of certain products. And API is the active ingredient of the drug, but also constitute the basis of the pharmacological effects of drugs.
2, The production of API must rely on intermediates
Pharmaceutical intermediates are chemical raw materials or chemical products in the process of drug synthesis, but also the production of API process intermediate products, is the product of synthetic API pathway, is the step in the API production process, must go through the next step of molecular changes or refining to become an API substance. And API can be used directly as a preparation.
3, Different production requirements
Pharmaceutical intermediates are intermediate products in the process of producing APIs, so pharmaceutical intermediates can be produced in ordinary chemical plants. If you want to produce API, you need to get the production license of API to produce.

In summary, reliable pharmaceutical intermediates and APIs are two very different substances, the threshold for producing pharmaceutical intermediates is relatively low, while the production of APIs needs to meet a higher production threshold. HAILI products mainly involve APIs, pharmaceutical intermediates and natural extracts, please contact us for product list and quotation.


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