What are pharmaceutical intermediates?

April 19, 2022

The pharmaceutical intermediate is actually some chemical raw materials or chemical products used in the process of drug synthesis. It is a fine chemical product in the production process from pharmaceutical chemical raw materials to API or drugs. This chemical product can be produced in ordinary chemical plants without a drug production license. As long as it reaches some levels, it can be used for drug synthesis.

The synthesis of chemical drugs depends on high-quality pharmaceutical intermediates. According to the regulations of the China food and drug administration, pharmaceutical intermediates can be regarded as drug raw materials, and there is no need to produce and apply for approval and batch number according to the drug rules. In contrast, although drugs are also fine chemical products, they are more stringent than general chemical plants, so pharmaceutical factories need GMP certification.

Looking at the whole industry, at present, the production of pharmaceutical intermediates in China has six characteristics:

1、Most of the production enterprises are private enterprises with flexible operation and small investment scale, basically between millions and 120 million yuan；

2、The geographical distribution of production enterprises is relatively concentrated；

3、With the increasing attention of the state to environmental protection issues, the pressure on production enterprises to build environmental protection treatment facilities is increasing；

4、Product update speed is fast. After a product is generally on the market for 3 ~ 5 years, its profit margin will decline significantly, which forces enterprises to constantly develop new products or continuously improve production technology in order to maintain high production profits；

5、Because the production profit of pharmaceutical intermediates is higher than that of chemical products, and their production processes are basically the same, more and more small chemical enterprises have joined the ranks of producing pharmaceutical intermediates, resulting in increasingly fierce disorderly competition in the industry；

6、Compared with API, the profit margin of producing intermediates is low, and the production process of API and pharmaceutical intermediates is similar. Therefore, some enterprises not only produce intermediates, but also use their own advantages to start producing API.

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Ms. Yi

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