The difference between pharmaceutical intermediates and raw materials

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

Active Pharmaceutical Ingredient (API): Any substance or mixture of substances intended for use in the manufacture of a drug and, when used in a drug, becomes an active ingredient of the drug. 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 raw material drug is an active product that has completed the synthetic route, and the intermediate is a product somewhere in the synthetic route. APIs can be prepared directly, while intermediates can only be used to synthesize next-step products, and APIs can only be produced through intermediates.

It can be seen from the definition that the intermediate is the key product of the previous process of making the raw material drug, which has a different structure from the raw material drug. In addition, there are detection methods for raw materials in the Pharmacopoeia, but not for intermediates. When it comes to certification, FDA currently requires intermediates to be registered, while COS does not, but CTD documents must have detailed process descriptions of intermediates. In China, there is no GMP mandatory requirement for intermediates.

Pharmaceutical intermediates do not require a production license like raw materials, and the entry threshold is relatively low and the competition is fierce. Therefore, quality, scale and management level are often the basis for the survival and development of enterprises, and the increasing pressure of environmental protection has also made 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 for relevant enterprises to improve profitability, increase added value, and continue to grow:

(1) Product diversification and high-end, from the production of extensive low-end intermediates to refined 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 raw materials and preparations downstream of intermediates.

Pharmaceutical intermediate industry customized production process

Intermediates refer to intermediate products in the compound synthesis process. Pharmaceutical intermediates are some chemical raw materials or chemical products used in the synthesis process of raw materials. They can be produced in ordinary chemical factories without the production license of raw materials. , as long as it reaches a certain level, it can be used in the synthesis of raw materials. The pharmaceutical intermediate industry can provide customized synthesis services for intermediates according to customer needs.

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

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

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

(3) Digest and improve the process of products in the mass production stage of customers, so as to meet the quality standards of foreign companies.

Custom synthesis service, we can design the synthesis route for the client's target molecule, and complete the synthesis and delivery of compounds on time, quality and quantity, including reference compounds, metabolites, reagents, intermediates, molecular fragments and impurities, etc.