The Link Between Intermediates and API Medicines

Both pharmaceutical intermediates and APIs belong to the category of fine chemicals. Intermediates are the key products of the pre-process of making API medicines, which are different in structure from API medicines.

1. The specific substances of intermediates and API medicines are different

Pharmaceutical intermediates are also known as organic pharmaceutical intermediates, refer to a semi-finished product, is the production of some products in a product.

While API medicines refer to the active ingredient of a drug, which is also the basic substance that constitutes the pharmacological action of a drug. An API is a pharmaceutically active substance prepared by chemical synthesis, plant extraction or biotechnology.

2. The production of API medicines must rely on intermediates

A pharmaceutical intermediate is a chemical raw material or a chemical product in the process of drug synthesis. It is also an intermediate product in the process of producing APIs. It is a product in the synthesis of API medicines and is produced in the process steps of APIs. It must undergo the next step of molecular change or refinement to become a substance in the bulk drug. The API can be directly used as preparation, while the intermediate can only be used to synthesize the next product, through which the API can be made.

3. The production requirements of intermediates and API medicines are different

Pharmaceutical intermediates are intermediate products in the process of producing raw materials, so pharmaceutical intermediates can be produced in ordinary chemical plants. If you want to produce APIs, you need to obtain a production license for the API medicine before you can start production.

To sum up, reliable pharmaceutical intermediates and active substances are two distinct substances, and the threshold for manufacturing pharmaceutical intermediates is relatively low, while the threshold for manufacturing active substances is higher. If want to become one of the active pharmaceutical ingredient manufacturers, you must also have appropriate pharmaceutical intermediates as raw materials.

4. The key point of improving the ability of pharmaceutical intermediate companies

Pharmaceutical intermediates do not require production licenses like APIs, 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 increasing environmental pressure has also caused many small companies to gradually withdraw from the competition arena, and the 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) Product diversification, from the production of extensive low-end intermediates to fine pharmaceutical 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.