What is a pharmaceutical intermediate? The difference between it and APIs!

What is a pharmaceutical intermediate? Difference between him and API! Pharmaceutical intermediates and APIs both belong to the category of fine chemicals. An intermediate is a material that is produced during the process steps of an API and can only become an API after further molecular changes or refinement. Intermediates may or may not be separated.

Active Pharmaceutical: 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 pharmacologic or other direct role in disease diagnosis, symptom relief, treatment or disease prevention, or may affect the function and structure of the body. A drug is an active product that has completed its synthetic pathway, and an intermediate is a product somewhere in the synthetic pathway. APIs can be produced directly, while intermediates can only be used to synthesize the next product, and APIs can only be produced through intermediates.

This definition suggests that an intermediate is a key product of the previous process of preparing an API and is structurally different from the API. In addition, the Pharmacopoeia contains test methods for APIs, but not intermediates. As for certification, FDA requires intermediates to be registered, not COS. however, the CTD document 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 APIs, and the entry barrier is relatively low and competitive. As a result, quality, scale and management level are often the basis for company survival and development. Increased pressure on environmental protection has also led to the gradual withdrawal of many small companies from the competitive stage, and industry concentration is expected to increase rapidly. It is generally believed that the following three directions will be the key to improving profitability, adding value and sustaining growth for the companies concerned:

(1) Product diversification from large-scale low-end intermediates to fine intermediates production;

(2) Taking the road of specialized outsourcing services, further expanding the outsourcing service industry chain and taking over R&D outsourcing services;

(3) Specializing in pharmaceutical and attack APIs and intermediate preparations.