Extraction of pharmaceutical intermediates and development of bulk drugs

Active Pharmaceutical Ingredient (API) refers to any substance or mixture of substances used in the manufacture of Pharmaceutical products that, when used in Pharmaceutical products, become an Active Ingredient of Pharmaceutical products. Such substances have pharmacological activities or other direct effects in the diagnosis, treatment, symptom relief, management or prevention of disease, or can affect the function or structure of the body.

From the perspective of upstream and downstream, API is the final product of pharmaceutical intermediates obtained through chemical synthesis, biological fermentation and extraction through 4-5 steps of upstream basic chemicals or animals and plants as basic raw materials. In the downstream, according to the actual functions and application scenarios, APIs can also be used in pharmaceutical preparations, feed, health care products, cosmetics and other fields, and the most important application scenarios are in pharmaceutical preparations.

China is a big producer of chemical raw materials, and the overall industrial chain layout is suitable for the development of pharmaceutical intermediate-api industry. However, in the early stage of development, due to a series of backward technology, capital and equipment, the whole API industry presents a trend of extensive development. Bulk API with high pollution and high energy consumption and low technical barrier has achieved rapid development in China, and some varieties even have excess capacity. However, the proportion of featured APIs and patent APIs with high technical barriers and higher gross margins is relatively low.

To this end, the state has issued a series of regulations and policies since 2016, emphasizing technology orientation and developing high-end characteristic APIS. From the perspective of policy development planning, on the one hand, it is necessary to consolidate the international competitive position of chemical apis and increase the proportion of refined and deep processing products exported. On the other hand, we should improve the green production level of chemical apis and enhance the market share of high-end featured apis. High-end featured APIS play an important supporting role in China's API industry.