Overview of pharmaceutical intermediates

The upstream of pharmaceutical intermediates is the basic chemical raw material industry. Basic chemical raw materials are used as commodities, and prices fluctuate greatly, which directly affects the production costs of enterprises.

However, pharmaceutical intermediates are subdivided into primary intermediates and advanced intermediates. Since primary intermediate suppliers can only provide simple intermediate production, they are at the forefront of the industrial chain, and competition pressure and price pressure are the most. The price fluctuation of basic chemical raw materials has a great impact on them. Advanced intermediate suppliers not only have strong bargaining power with primary suppliers, but more importantly because they undertake the production of advanced intermediates with higher technical content and maintain closer ties with multinational companies, so Raw material price fluctuations have little effect on it.

Speaking of certification, the FDA currently requires intermediates to be registered, and COS (European Pharmacopoeia Adaptability Certification, only drugs that pass this certification can be sold in the EU market), but the CTD file requires a detailed process description of the intermediate. In China, there are no GMP mandatory requirements for intermediates.

Pharmaceutical intermediates do not require production permits like APIs. The entry barrier is relatively low and competition is fierce. Therefore, quality, scale and management level are often the fundamentals for the survival and development of enterprises. The increased pressure on environmental protection has also caused many small enterprises to 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 related companies 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 fine 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 the raw materials and preparations downstream of intermediates.

Analysis of API industry

In recent years, China's API companies have gradually completed the upgrade of product structure from bulk APIs to specialty APIs and intermediates. The industry's leading companies have further expanded the R & D layout of high barrier generic drug APIs that have not yet expired.

China has a complete upstream and downstream industry chain, low cost, and good talent reserve. It is one of the few industries in the domestic pharmaceutical subdivision that has an advantage in international competition.