Intermediate refers to the intermediate product in the process of compound synthesis. Pharmaceutical intermediates are some chemical raw materials or chemical products used in the process of API synthesis. They can be produced in ordinary chemical plants without the production license of API. As long as they reach some level, they can be used for the synthesis of API. Pharmaceutical intermediates industry can be customized according to customer demand for intermediate synthesis services.

1, pharmaceutical intermediates industry customized production process

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

(1) Participate in the customer's research and development of new drugs, which requires the company's research and development center to have strong innovation capabilities;

(2) Scale up the customer's pilot products to meet the process route of large-scale production, which requires the company's ability to scale up the engineering of the products and the ability to continuously improve the technology of customized products in the later stage, so as to meet the needs of large-scale production of products, continuously reduce production costs and enhance the competitiveness of products;

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

Medissi provides customized synthesis services that can design synthetic routes for customers' target molecules and complete the synthesis and delivery of compounds on time, quality and quantity, including control compounds, metabolites, reagents, intermediates, molecular fragments and impurities.

2. The difference between pharmaceutical intermediates and APIs

Pharmaceutical intermediates and APIs belong to the category of fine chemicals, intermediates are produced in the process steps of the API, must undergo further molecular changes or refining to become a material of the API, intermediates can be separated or not separated. (Note: This guidance covers only intermediates that are defined by the company as being manufactured 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 pharmaceutical product and, when used in the manufacture of a pharmaceutical product, an active ingredient of a pharmaceutical product. Such substances have pharmacological activity or other direct effects in the diagnosis, treatment, alleviation of symptoms, management, or prevention of disease, or can affect the function and structure of the body. A drug substance is an active product that has completed the synthetic pathway, and an intermediate is a product somewhere in the synthetic pathway. API can be directly prepared, and intermediates can only be used to synthesize the next product, only through the intermediate to manufacture the API.

Custom synthesis of intermediates

As can be seen from the definition, intermediates are the key products of the previous process of making API, which are different from the structure of API. In addition, the pharmacopoeia has the detection method of the drug substance, but there is no intermediate. When it comes to certification, FDA currently requires intermediates to be registered, while COS does not, but CTD documents require detailed process descriptions of intermediates. 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 basis for the survival and development of enterprises, and the increasing pressure on environmental protection also makes many small enterprises 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 sustainable growth of relevant enterprises:

(1) Product diversification and high-end, from the production of extensive low-end intermediates to fine high-end intermediates;

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

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