What is a pharmaceutical intermediate? The difference between it and an API!
Release time:
2024-06-12
What is a pharmaceutical intermediate? The difference between him and API! Pharmaceutical intermediates and APIs belong to the category of fine chemicals. An intermediate is a material that is produced in the process steps of a drug substance and can only become a drug substance after further molecular changes or refinement. The intermediate may or may not be isolated.
Active Drug: Any substance or mixture of substances used in the manufacture of a medicinal product which, when used in a medicinal product, becomes the active substance of the medicinal product. The substance has a pharmacological or other direct effect in the diagnosis, alleviation of symptoms, treatment or prevention of disease, or may affect the function and structure of the body. A drug is an active product that has completed a synthetic pathway, and an intermediate is a product somewhere in the synthetic pathway. The API can be produced directly, while the intermediate can only be used to synthesize the next product, and the API can only be produced through the intermediate.
This definition indicates that the intermediate is a key product of the previous process for the preparation of the drug substance, and its structure is different from the drug substance. In addition, the pharmacopoeia contains testing methods for drug substances, but no intermediates. As for certification, the FDA requires that intermediates must be registered, not COS. However, the CTD file should contain a detailed process description of the intermediate. China has no mandatory GMP requirements for intermediates.
Pharmaceutical intermediates do not require production licenses such as raw materials, entry barriers are relatively low, and competition is fierce. Therefore, quality, scale and management level are often the basis for the survival and development of the company. The increase in environmental protection pressure has also caused many small companies to gradually withdraw from the competition stage. It is expected that the industry concentration will increase rapidly. It is generally believed that the following three directions will be the key to the company concerned to improve profitability, increase added value and maintain growth:
(1) Product diversification, from large-scale low-end intermediates to the production of fine intermediates;
(2) Take the road of professional outsourcing services, further expand the outsourcing service industry chain, and take over R & D outsourcing services;
(3) Focus on pharmaceuticals and attack APIs and intermediate preparations.
Related News
SAF Coolest v1.3 设置面板 GAGSD-ZGYF-JESSE-ZVD
无数据提示
Sorry, the current column has no content for the time being.!
You can view other columns or returnHome Page