The Difference Between the Original Drug and API Pharmaceutical

1. Know about API pharmaceutical

API pharmaceutical refers to the raw materials used in the production of various preparations. It is the active ingredient in the preparation. Various powders, crystals, extracts, etc. prepared by chemical synthesis, plant extraction or biotechnology are used for medicinal purposes. Substances that the patient cannot take directly.

The well-established definition of API pharmaceutical in ICH Q7A: refers to any substance or mixture of substances that is used in the manufacture of pharmaceuticals and, when used in pharmaceuticals, becomes an active ingredient of a pharmaceutical. Such substances have pharmacological activity or other direct effects in the diagnosis, treatment, symptomatic relief, management or prevention of disease, or can affect the function or structure of the body. Active ingredient of medicine. Only when API pharmaceutical is processed into pharmaceutical preparations can it become a medicine for clinical application. API pharmaceutical is divided into two categories according to its source: chemical synthetic drugs and natural chemical drugs.

2. The difference between the original research drug and API pharmaceutical

Original research drug: It is called genuine drug in the market, which refers to the original research and development of new drugs. Only after thousands of compounds are screened and rigorously tested in clinical trials, they can be approved for marketing by relevant professional institutions. The original research drug needs to spend as short as 5 years, as long as 15 years of research and development time and investment of hundreds of millions of funds, so there is a reason for its high price when it is launched. The general steps to go through the marketing of the original research drug: project approval (4 months); preclinical research (9-24 months); clinical research application (more than 1 year); clinical trial approval; clinical research (3-5 years); production application (1-n years); review and on-site inspection after acceptance of the notice; approval for production and listing (about 6 months); monitoring period.

API pharmaceutical: API pharmaceutical is the upstream of normal pharmaceuticals. Strictly speaking, API pharmaceutical is not directly "eaten" for patients, because it is not a medicine, but is just a raw material like other chemical products. For a drug, the active ingredient of the drug is the main ingredient of the drug, and the other ingredients are called "excipients". API pharmaceutical has the same or similar active pharmaceutical ingredients as the original drug, but has not undergone the formulation process. However, these small molecule targeted drugs have special acid-base coefficients, which require precise dissolution rate in the preparation, so as to ensure that they disintegrate at the correct time when they reach the gastric acid environment, dissolve at the correct speed, and obtain the appropriate absorption rate.