API is Any substance or mixture of substances intended for use in the manufacture of pharmaceuticals.
API (Active Pharmaceutical Ingredient) is the perfect definition of API in ICH Q7A: any substance or mixture of substances intended to be used in the manufacture of pharmaceuticals, and when used in pharmaceuticals, it becomes a type of pharmaceutical Active ingredient.
Such substances have pharmacological activity or other direct effects in the diagnosis, treatment, symptomatic relief, management or prevention of disease, or it can affect the function or structure of the body.
The raw materials are used in the production of various preparations, and is a variety of powders, crystals, extracts, etc., which are prepared by chemical synthesis, plant extraction or biotechnology for the active ingredients in preparations for medicinal purposes. Substances that cannot be taken directly. API is Active ingredient of medicine.
Only after being processed into pharmaceutical preparations can APIs become clinically applicable medicines. APIs are classified into two categories according to their sources: chemical synthetic drugs and natural chemical drugs.Chemical synthetic drugs can be divided into inorganic synthetic drugs and organic synthetic drugs. Inorganic synthetic drugs are inorganic compounds (very few are elements) ,such as aluminum hydroxide, magnesium trisilicate, etc, are used to treat gastric and duodenal ulcers; organic synthetic drugs are mainly composed of basic organic chemical raw materials after a series of organic Drugs produced by chemical reactions (such as aspirin, chloramphenicol, caffeine, etc.).
According to their sources, natural chemical drugs can also be divided into two categories: biochemical drugs and phytochemical drugs.
Antibiotics are generally produced by microbial fermentation and belong to the category of biochemistry. A variety of semi-synthetic antibiotics that have appeared in recent years are products that combine biosynthesis and chemical synthesis.
Among the raw materials, the variety, output and output value of organic synthetic drugs occupies the largest proportion, which is the main pillar of the chemical and pharmaceutical industry. The quality of the API determines the quality of the preparation, so its quality standards are very strict. Countries around the world have formulated strict national pharmacopoeia standards and quality control methods for the widely used APIs.
The pharmaceutical market is expected to maintain a growth rate of more than 8% in 2014, the emerging pharmaceutical market is likely to maintain a larger growth rate, and the international and domestic market demand for APIs will continue to grow up.
Many of China's API varieties occupy a relatively high market share in the international market and have obvious scale advantages, which is hard to be replaced by other countries in the short term.
