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

What are pharmaceutical intermediates? The difference between him and API! Both pharmaceutical intermediates and apis fall into the category of fine chemicals. An intermediate is a material that is produced during the process step of a drug substance and can only become a drug substance after further molecular changes or refining. The intermediates may or may not separate.

Active drug: Any substance or mixture of substances used in the manufacture of a pharmaceutical product that, when used in a pharmaceutical product, becomes the active substance of the pharmaceutical product. The substance has a pharmacological or other direct role 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 synthetic path, and an intermediate is a product somewhere along the synthetic path. The API can be produced directly, while the intermediate can only be used to synthesize the next product, and the API can only be produced through the intermediate.

This definition indicates that the intermediate is a key product of the previous process of preparing the API and has a different structure than the API. In addition, the pharmacopoeia contains testing methods for apis, but no intermediates. As for certification, the FDA requires that intermediates must be registered, not COS. However, the CTD document should contain detailed process descriptions of the intermediates. China does not have mandatory GMP requirements for intermediates.

Pharmaceutical intermediates do not require production licenses such as apis, and the entry threshold is relatively low and competition is fierce. Therefore, the quality, scale and management level are often the basis for the survival and development of the company, the increase in environmental protection pressure has also made many small companies gradually withdraw from the competition stage, and the industry concentration is expected to increase rapidly. It is generally believed that the following three directions will be the key to improving profitability, increasing added value and sustaining growth for relevant companies:

(1) Product diversification, from large-scale low-end intermediates to fine intermediates production;

(2) Take the road of professional outsourcing services, further expand the outsourcing service industry chain, and take over R&D outsourcing services;

(3) Focus on medicine and attack pharmaceutical ingredients and intermediates.