What is an API Drugs?

What is an API Drugs?

API drugs refer to the raw materials used in the production of various preparations. They are the effective ingredients in the preparations. Various powders, crystals, extracts, etc., prepared by chemical synthesis, plant extraction or biotechnology, are used for medicinal purposes. Substances taken directly.

APIs, also known as active ingredients of drugs, are prepared by chemical synthesis, plant extraction or biotechnology, but are not directly taken by the patient, usually after adding excipients and processing to make drugs that can be used directly.

The raw material medicine is like flour. The stable production and sales of steamed buns and steamed bread (drugs) are inseparable from a stable supply of raw material medicines. In some respects, raw material medicines control the vitality of medicines. There are many good medicines in the past. Probably because of the unavailable supply of raw materials, production was discontinued.

The complete definition of API in ICHQ7A: It is intended to be used in any substance or mixture of substances in the manufacture of pharmaceuticals, and when used in pharmaceuticals, it becomes an active ingredient of pharmaceuticals. Such substances have pharmacological activity or other direct effects in the diagnosis, treatment, symptom relief, treatment or prevention of diseases, or can affect the function or structure of the body.

The active ingredients of pharmaceuticals, raw materials, can only be processed into pharmaceutical preparations before they can be used for clinical applications. According to its source, raw materials are divided into two categories: synthetic chemical drugs and natural chemical drugs.

1. Chemical synthetic drugs can be divided into inorganic synthetic drugs and organic synthetic drugs. Inorganic synthetic drugs are inorganic compounds (extremely elements), such as aluminum hydroxide and magnesium trisilicate used to treat gastric and duodenal ulcers; organic synthetic drugs are mainly composed of basic organic chemical raw materials, through a series of organic Drugs made by chemical reactions (such as aspirin, chloramphenicol, caffeine, etc.).
2. Natural chemical drugs can also be divided into two categories: biochemical drugs and phytochemical drugs according to their sources. 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 the products of a combination of biosynthesis and chemical synthesis. Among the raw materials, organic synthetic drugs account for the largest proportion of varieties, output and output value, and are the main pillars of the chemical pharmaceutical industry. The quality of raw materials determines the quality of preparations. Therefore, the quality standards are very strict. Countries around the world have formulated strict national pharmacopoeia standards and quality control methods for their widely used raw materials.