What Is the Difference Between Apis and Pharmaceutical Intermediates?

Both pharmaceutical intermediates and APIs belong to the category of fine chemicals. Intermediates are materials produced in the process steps of APIs that must undergo further molecular changes or refinement to become APIs. Intermediates can be separated or not separated. (Note: This guide only covers intermediates that the company defines as produced after the starting point of API production.)

Active pharmaceutical ingredient (API): Any substance or mixture of substances intended for use in the manufacture of a drug and, when used in the manufacture of a drug, becomes an active ingredient in the drug. Such substances have pharmacological activity or other direct effects in the diagnosis, treatment, symptom relief, management or prevention of diseases, or can affect the functions and structures of the body. APIs are active products that have completed the synthesis pathway, while intermediates are products somewhere along the synthesis pathway. APIs can be prepared directly, while intermediates can only be used to synthesize the next step of the product. Only through intermediates can APIs be manufactured.

It can be seen from the definition that intermediates are key products in the front-end process of making APIs and have different structures from APIs. In addition, there are testing methods for raw materials in the Pharmacopoeia, but not for intermediates. Speaking of certification, currently FDA requires intermediates to be registered, but COS does not. However, the CTD file must have a detailed process description of the intermediate. In China, there are no mandatory GMP requirements for intermediates.

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