Analysis of the Difference Between Intermediates and APIs

Intermediates refer to intermediate products in the process of compound synthesis. Pharmaceutical intermediates are some chemical APIs or chemical products used in the synthesis process of APIs. They do not require a production license for APIs and can be produced in ordinary chemical plants. , As long as it reaches a certain level, it can be used for the synthesis of APIs. The pharmaceutical intermediate industry can provide customized intermediate synthesis services according to customer needs.

Customized production process in the pharmaceutical intermediate industry

Customized products are divided into 3 levels according to the closeness of cooperation with customers:

(1) Participating in the customer’s new drug development stage, which requires the company’s R&D center to have strong innovation capabilities;

(2) Amplify the customer’s pilot products to meet the process route of large-scale production. This requires the company’s engineering amplification capabilities for products and subsequent continuous process improvement capabilities for customized product technologies, so as to meet the needs of product scale production. Continuously reduce production costs and improve product competitiveness;

(3) Process digestion and improvement of the products at the customer’s large-scale production stage, so as to meet the quality standards of foreign companies.

Medicilon provides customized synthesis services, which can design synthetic routes for customers’ target molecules, and complete the synthesis and delivery of compounds on time, quality and quantity. These compounds include reference compounds, metabolites, reagents, intermediates, molecular fragments and impurities, etc. .

The difference between pharmaceutical intermediates and APIs

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

Active medicinal ingredient (API): Any substance or mixture of substances intended to be used in the manufacture of medicines, and when used in medicine, it becomes an active ingredient of medicines. Such substances have pharmacological activity or other direct effects in the diagnosis, treatment, symptom relief, treatment or prevention of diseases, or can affect the function and structure of the body. The bulk drug is an active product that has completed the synthetic route, and the intermediate is a product in a certain place in the synthetic route. The API can be directly formulated, and the intermediate can only be used to synthesize the next product. Only through the intermediate can the API be manufactured.

It can be seen from the definition that intermediates are the key products of the previous process of making APIs, which are different in structure from APIs. In addition, the pharmacopoeia has testing methods for APIs, but no intermediates. Speaking of certification, the FDA currently requires that intermediates must be registered, while COS does not, but the CTD file must have a detailed process description of the intermediate. In China, there is no GMP mandatory requirement for intermediates.

Pharmaceutical intermediates do not require production licenses like APIs, and the barriers to entry are relatively low and competition is fierce. Therefore, quality, scale, and management level are often the foundation for the survival and development of enterprises, and the increasing pressure on environmental protection has caused many small enterprises to gradually withdraw from the competition arena, and industry concentration is expected to increase rapidly. It is generally believed that the following three directions will be the key to relevant companies to improve profitability, increase added value, and continue to grow:

(1) Products are diversified and high-end, from the production of extensive low-end intermediates to fine high-end intermediate products;

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

(3) Focus on pharmaceuticals and attack the downstream APIs and preparations of intermediates.