Pharmaceuticals

What are APIs?

APIs (Active Pharmaceutical Ingredients) are responsible for the pharmaceutical effect of formulated pharmaceuticals (medicines).

They are produced using highly technological industrial processes, both during the R&D and commercial production phases.

All medicines are made up of two core components: the API, active ingredient, and the excipient. The API is the substance that produces the intended therapeutic effect. It is the biologically active component responsible for treating, preventing, or diagnosing a disease.

Excipients are not intended to have a therapeutic effect, but are necessary to manufacture, deliver, stabilise, preserve, or improve the performance of the medicinal product.

Europe traditionally has a very strong and important API manufacturing base with a high level of technical competence, employing a range of skilled, highly qualified and experienced staff.

How is a pharmaceutical specialty developed?

5 PHASES - 10 YEARS

The development of a new pharmaceutical specialty is long and costly and can last up to ten years.

Discovery
phase

Several hundred or sometimes thousand molecules are subjected to preliminary laboratory tests.

Preclinical
phase

During this preclinical phase, pharmacological screening, including toxicological, in vitro, in vivo and in silico studies.

3 phases of clinical trials

on an increasingly large number of subjects

These phases evaluate the efficacy and safety of medicines on large number of volunteer patients.

At the end of this selection process,
Only one in ten molecules remain that can proceed to Clinical Phases 1, 2 and 3 subject to prior authorisation by the competent national authorities, and very few of them make it to the end of the full selection process (screening and clinical trials).