Difference between Pharmaceutical Intermediates and APIs

What is a Pharmaceutical Intermediate? What is the difference between it and API? Pharmaceutical intermediates and APIs both belong to the category of fine chemicals.

2-Bromo-1-phenyl-1-pentanone | CAS 49851-31-2
2-Bromo-1-phenyl-1-pentanone | CAS 49851-31-2

Difference in definition between pharmaceutical intermediates and APIs

Pharmaceutical intermediates: materials produced in the process steps of an API that must undergo further molecular changes or refinement to become a material for the API. Intermediates may or may not be separated.

API: Active Pharmaceutical Ingredient, any substance or mixture of substances used in the manufacture of a drug that becomes the active ingredient of the drug. The substance is pharmacologically active or otherwise has a direct effect on the diagnosis, treatment, symptomatic relief, cure, or prevention of disease, or may affect the function and structure of the body.

cas 374675-21-5
cas 374675-21-5

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 a pharmaceutical intermediate is a product somewhere in the synthetic pathway.

APIs can be produced directly, whereas 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 assays for APIs but not intermediates.

cas 374675-21-5
cas 374675-21-5

Differences from the perspective of drug development

Looking at the difference between the two from the point of view of new drug development, APIs are those that have undergone sufficient pharmacological research to be safe for therapeutic and diagnostic use in humans. Pharmaceutical intermediates are compounds in the process of synthesizing APIs that are not necessarily therapeutically effective or toxic. Please note that this does not necessarily mean that some intermediates in the synthesis process of APIs are also APIs.

Differences between pharmaceutical intermediates and APIs in terms of certification

Regarding certification, the FDA requires intermediates to be registered, not COS. however, the CTD document should contain a detailed process description of the intermediate. APIs (APIs) If an API company submits a very simple synthetic route for an API, the FDA considers the risk control insufficient if there is only one step of the reaction and is likely to extend the inspection of the intermediates. Intermediate management is generally based on ISO or Q7a, which allows for quality system management.

Acetaminophen | CAS 103-90-2
Acetaminophen | CAS 103-90-2

Difference between the two from the perspective of drug administration

Regarding drug management, APIs should apply for registration with the Food and Drug Administration (SFDA in China, FDA in the US, and EMA in Europe) according to the law, and synthesize in GMP-compliant factories after obtaining the approval number.

Intermediates are just intermediate products in the process of synthesizing APIs and do not need to obtain a document number. It should be noted that compounds that are identical to APIs do not obtain a document number and are not produced in GMP plants.

Pharmaceutical intermediates do not need production licenses such as APIs, the entry threshold is relatively low and competition is fierce. 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.

How to improve the profitability of a pharmaceutical intermediates company?

It is generally recognized that the following three directions will be 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 the R&D outsourcing services;

(3) Focusing on the production of APIs and intermediate preparations;

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