What Are the Differences Between Pharma Intermediates and APIs?

1. What are pharma intermediates?

Intermediates refer to semi-finished products, which are intermediate in the production of certain products. For example, to produce a product can be produced from intermediates to save costs. Pharmaceutical production requires a large number of special chemicals. Most of these chemicals were originally produced by the pharmaceutical industry. However, with the deepening of the social division of labor and the advancement of production technology, the pharmaceutical industry has transferred some pharma intermediates to chemical companies for production. Pharma intermediates are fine chemical products, and the production of pharma intermediates has now become a major industry in the international chemical industry.

2. What is the difference between pharma intermediates and APIs (active pharmaceutical ingredients)?

Pharma intermediates are a kind of materials that are produced in the process steps of APIs and must undergo further molecular changes or refining to become APIs, and the intermediates can be separated or not separated. An API is an active pharmaceutical ingredient, which is intended to be used in any substance or mixture of substances in the manufacture of medicines. And when used in pharmaceuticals, it becomes an active ingredient of medicines. 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 and structure of the body. For example, amoxicillin capsules are called preparations, amoxicillin is called API, and 6-APA is called intermediates.

From the definition, you will find that pharma intermediates are the key products of the previous process of making APIs, which are different in structure from APIs. In addition, pharmacopeia has testing methods for APIs, but no testing methods for intermediates. Speaking of certification, the FDA currently requires that intermediates must be registered, while COS does not, but the CTD file must have a detailed process description of the intermediates.