The Difference Between API And Intermediates

Jan. 04, 2023

Drug intermediates are drugs used as APIs to produce APIs and can also refer to substances produced during the synthesis of APIs that must undergo further molecular changes or processing to become APIs. Drug intermediates are hygienically formulated using high quality raw materials and are used in the pharmaceutical and cosmetic industries.

Pharmaceutical companies use pharmaceutical intermediates for research and development purposes. Pharmaceutical intermediates, veterinary intermediates and API intermediates are various types of drug intermediates. The global drug intermediates market is expected to grow at a high rate due to the increase in R&D activities across the globe.

N-Ethyl-o-toluenesulfonamide

What is an API?

An API (active pharmaceutical ingredient) is the active ingredient contained in a drug. Any substance or mixture of substances intended to be used in the manufacture of a drug (medicine) which, when used in the manufacture of a drug, will be the active ingredient in a pharmaceutical product. Such substances are intended to provide pharmacological activity or other direct action for the diagnosis, cure, relief, treatment or prevention of disease, or to affect the structure or function of the body.

What are pharmaceutical intermediates?

Pharmaceutical intermediates are the compounds that form the basis of an active pharmaceutical ingredient (API). A pharmaceutical intermediate is a by-product of the API production process. each reaction in the API production process produces a number of different pharmaceutical intermediates. It can only be converted to API by further molecular changes or refinement. intermediates can be isolated or not. Pharmaceutical intermediates are used in the production of APIs and are also used by various pharmaceutical and biopharmaceutical companies for research and development purposes.

4-aMino-2,6-bis(pyrrolidin-1-ylMethyl)phenol

What is the difference between an API and an intermediate?

From a new drug development point of view, APIs are compounds that have undergone adequate pharmacological studies and are safe for use in humans for therapeutic diagnosis. Pharmaceutical intermediates are compounds from the API synthesis process that may not be therapeutic or toxic. Please note that this is not necessarily the case and that some intermediates in the synthesis of APIs are also APIs.

From a pharmaceutical regulatory point of view, APIs must be legally registered with the drug regulatory authorities (US FDA, European EMEA), receive an approval number and then be synthesised in a GMP compliant facility. The intermediate is simply a by-product of the API synthesis process and does not need to obtain an approval number. It is important to note that some compounds, although identical to APIs, are not APIs if they do not have an approval number or are not manufactured in a GMP facility.

Traditionally, APIs and intermediates have been produced by national pharmaceutical companies. In recent years, however, many companies have chosen to move manufacturing overseas to reduce costs. As a result, many pharmaceutical companies are located in the USA and the UK, but most API and intermediate manufacturers are located overseas. The largest areas are in Asia, particularly India and China. Some studies have shown that production costs associated with pharmaceutical intermediates, APIs and final drug formulations are around 50-60% lower in emerging Asian markets compared to North America and Europe. This has led to significant changes in the way these drugs are regulated, with more stringent guidelines and inspections being implemented.

Fanbo Pharmaceutical, a leading Chinese manufacturer of APIs and intermediates, provides API and pharmaceutical intermediates with high quality and competitive prices.