What is the definition of an API? What are the specific classifications of APIs?

API (active pharmaceutical ingredient, usually abbreviated as API), which is defined in China as any substance or mixture of substances used in the manufacture of pharmaceuticals, is the active ingredient of all kinds of preparations. This substance will have an effect on the function of the organism, and will have pharmacological activity in the diagnosis and treatment of disease, relief and prevention. Clinically used drugs or pharmaceutical preparations are processed from various raw materials.

The World Health Organization (WHO) on the definition of API is: API is any used in finished pharmaceutical products, designed to provide pharmacological activity; or on the disease in the diagnosis, treatment, palliation or prevention of the role of; or on the role of human physiological function of the restoration of the corrective or improvement of the substance or combination of substances.

APIs form the basis of every final formulated product and are a core part of manufacturing safe and effective pharmaceuticals. It is mainly a derivative of the specialty chemicals/fine chemicals industry. Currently there are more than 2,000 APIs in the world, only a few large formulation manufacturers can produce their own APIs and none of them can produce all the APIs they need.

According to the source can be divided into two categories of chemically synthesized APIs and natural chemical APIs.

Chemically synthesized APIs

Chemical synthetic APIs can be divided into inorganic synthetic APIs and organic synthetic APIs. Inorganic synthetic APIs for inorganic compounds, such as aluminum hydroxide for the treatment of the stomach; organic synthetic APIs mainly refers to organic chemical raw materials through a series of organic chemical reactions and the raw materials obtained (aspirin, etc.).

Natural chemical APIs

Natural chemical APIs can be divided into two categories according to the source of biochemical APIs and phytochemical APIs.