What is the definition of active pharmaceutical ingredients?

What is an active pharmaceutical ingredient

Active pharmaceutical ingredient (API), commonly abbreviated as API in China, refers to any substance or mixture of substances used in drug manufacturing, which is the active ingredient of various formulations. This substance has an impact on the functions of the body and has pharmacological activity in the diagnosis, treatment, relief, and prevention of diseases. The drugs or drug preparations used in clinical practice are processed from various raw materials.

The definition of active pharmaceutical ingredient (API) by the World Health Organization (WHO) is: API refers to any substance used in a finished pharmaceutical product to provide pharmacological activity; Or in the diagnosis, treatment, alleviation, or prevention of diseases; Or a substance or combination of substances that can restore, correct, or improve human physiological functions.

Raw materials are the foundation of every final formulation product and the core part of manufacturing safe and effective drugs. Mainly derivatives of specialized chemicals/fine chemicals industry. At present, there are over 2000 types of active pharmaceutical ingredients worldwide, and only a few large formulation manufacturers can produce active pharmaceutical ingredients on their own, and none of them can produce all the active pharmaceutical ingredients they need.

What are the specific classifications of active pharmaceutical ingredients

According to their sources, they can be divided into two categories: chemically synthesized raw materials and natural chemical raw materials.

According to different stages of patent, active pharmaceutical ingredients can be divided into three categories: bulk active pharmaceutical ingredients, specialty active pharmaceutical ingredients, and patented active pharmaceutical ingredients.