Critical and strategic medications: the value of the components that make their manufacturing possible

The security of supply depends on the active ingredients and the intermediates necessary to produce them. The companies specialized in these stages provide essential industrial capabilities so that the treatments reach the patient.

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The availability of medications is part of the debate on the strategic autonomy of Spain and the European Union. Along with the research of new treatments and access to innovation, a question that is receiving more and more attention has gained relevance: the ability to maintain the production of the medications that the healthcare system needs.

In Spain, the Spanish Agency of Medicines and Health Products identifies strategic medications based on their health importance and the vulnerability of their supply. This perspective allows focusing on treatments whose absence can have a significant impact on patient care and on the necessary conditions to guarantee their availability.

Behind that availability exists an industrial chain made up of companies with different and complementary functions. Some manufacture the finished medication; others produce the substances that compose it or develop the necessary processes to obtain them. Although their activity is less visible, these stages help to understand what it means to have a solid pharmaceutical industry.

The role of active ingredients

Active ingredients, also known as API by its initials in English —active pharmaceutical ingredients—, are the substances responsible for the pharmacological activity of a medication. Their incorporation into a formulation allows obtaining the different presentations used in clinical practice, such as tablets, capsules, or injectable solutions.

The manufacturing of these active ingredients requires technical knowledge, industrial processes, and specific quality controls. In turn, to obtain them, chemical intermediates may be necessary: substances that are transformed throughout the different stages of production until they give rise to the active ingredient.

Therefore, the security of supply is related to the entirety of this process. The ability to manufacture a medication also depends on the availability of the necessary components and the continuity of the companies involved in its production. The active ingredients and intermediates are part of the same value chain, in which each stage contributes to the final result.

An industry of complementary capacities

This chain does not have to focus on a single company. Specialization allows different companies to contribute expertise in certain products, technologies, or processes, which are later integrated into the manufacturing of the drug.

In this field, Deretil develops its activity, manufacturing side chains and chemical intermediates used in the production of beta-lactam antibiotics. Its work is situated in the phases prior to obtaining the finished drug and connects specialized chemistry with the pharmaceutical industry.

The activity of this type of company allows for approaching a less known dimension of the sector: that of the industrial capabilities that make it possible to produce components necessary for other manufacturers. Its contribution includes both the elaboration of those substances and the accumulated knowledge about the processes and their improvement.

The connection between industry and health

European attention to critical medicines has contributed to giving greater visibility to these capabilities. The provisional agreement on the Critical Medicines Act contemplates strengthening European manufacturing of medicines and active ingredients, along with the diversification of supply chains. This framework reflects the increasingly close relationship between health policy and industrial capacity.

In this context, knowing how a drug is manufactured helps to better understand the factors that influence its availability. Before reaching a pharmacy or a hospital, a treatment has gone through different stages involving substances, processes, and specialized companies.

Active ingredients and intermediates are part of that journey. Making their function known allows for completing the picture of an industry whose work begins long before the drug reaches the hands of the patient.