What is a pharmaceutical intermediate?

The so-called pharmaceutical intermediates are actually some chemical raw materials or products used in the process of drug synthesis. They are a fine chemical product in the production process from pharmaceutical raw materials to raw materials or drugs. This chemical product does not require a production license for drugs and can be produced in ordinary chemical plants. As long as it reaches a certain level, it can be used for drug synthesis.

The synthesis of chemical drugs relies on high-quality pharmaceutical intermediates. According to the regulations of the China National Medical Products Administration, pharmaceutical intermediates can be regarded as raw materials for drugs and do not need to be produced and approved according to drug regulations or batch number applications. In contrast, although drugs are also classified as fine chemical products, they have stricter requirements than general chemical factories, so pharmaceutical factories require GMP certification.

Looking at the entire industry, there are currently six major characteristics of pharmaceutical intermediate production in China:

1、 Most production enterprises are private enterprises with flexible operations and small investment scales, ranging from several million to one to twenty million yuan;

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

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

4、 The product update speed is fast. After a product is usually on the market for 3-5 years, its profit margin drops significantly, which forces companies to constantly develop new products or improve production processes in order to maintain high production profits;
5、 Due to the higher production profits of pharmaceutical intermediates compared to chemical products, and the fact that their production processes are essentially the same, more and more small chemical enterprises have joined the ranks of producing pharmaceutical intermediates, leading to increasingly fierce competition in the industry;

6、 Compared with active pharmaceutical ingredients, the profit margin of intermediate production is relatively low, and the production process of active pharmaceutical ingredients is similar to that of pharmaceutical intermediates. Therefore, some companies have not only produced intermediates, but also started to produce active pharmaceutical ingredients using their own advantages.