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What is an API?
- API = active pharmaceutical ingredient: the biologically active substance in a medicine that delivers the pharmacological effect.
- A single dose of a finished medicine typically contains only milligrams – or even micrograms – of active substance.
- API production involves complex chemical or biotechnological processes carried out under strict regulatory standards.
- Without reliable API supply, finished pharmaceutical products cannot be manufactured.
Much of Europe's supply of essential APIs comes from manufacturers outside the EU – a dependency that has left medicine supply chains vulnerable. The proposed Critical Medicines Act is a direct response to this, putting API manufacturing within Europe firmly in focus.
Orion’s subsidiary Fermion is one such active pharmaceutical ingredient manufacturer. Its API production plays a central role in Orion’s presence in Europe and helps strengthen pharmaceutical resilience for patients within the region.
Fermion manufactures around thirty APIs in total, making it one of the leading API producers in the Nordics and a significant global supplier of certain products. The active substances are both for Orion’s own medicines and the drugs of other pharmaceutical companies, and they are used in innovative as well as generic medicines.
One success story is Orion’s innovative prostate cancer medicine, which has already helped around 200,000 patients worldwide since its first marketing authorization in 2019. Fermion produces the active ingredient in Hanko, while tablet manufacturing takes place in Espoo.
This achievement reflects advanced production technology and deep expertise in chemical process and analytical development – a powerful example of what becomes possible when research, API production and finished-dose manufacturing come together in Finland.
Two API production sites in Finland with complementary strengths
Fermion operates two API manufacturing facilities in Finland: one in Hanko and one in Oulu. In Hanko, Fermion manufactures active ingredients in large volumes, with annual demand measured in tonnes. Last year, expansions to API manufacturing capacity at the Hanko site began, supporting its strategy to meet rising global demand for APIs.
The Oulu plant, recognized as the world’s northernmost API facility, focuses on smaller-scale production, including APIs whose yearly demand may amount to only a few kilos. In Oulu, multiple APIs are produced that appear on the current European critical medicines list.
Europe is heavily dependent on manufacturers outside the EU for APIs, intermediates, and raw materials, says Kim Nylund, SVP, Fermion. Maintaining API production in Finland helps reduce Europe’s dependency on external suppliers and supports resilience in medicine manufacturing, he explains.
“The COVID-19 pandemic demonstrated how vulnerable global supply chains can become when critical production is concentrated outside Europe. Resilience becomes dependent on external factors,” Nylund adds.
Thanks to our expertise across research, development and operations, we can keep improving the way we manufacture APIs.
Why having API and medicine production under one roof matters
By maintaining API production within Orion, the company can modify its operations relatively quickly and with reasonable measures when demand shifts, Nylund explains.
In select cases, Fermion has demonstrated the ability to respond to increased demand for certain APIs and corresponding medicines within a short timeframe – an agility that Orion continues to strengthen. According to Nylund, having API production in Finland is not just valuable for proximity, but the fact that Orion controls the research and development of APIs.
“Thanks to our expertise across research, development and operations, we can keep improving the way we manufacture APIs. Small changes in the process can increase production and help medicines work better for patients.”
As a Nordic manufacturer with two API factories and pharmaceutical product manufacturing in Finland, Orion plays a practical role in supporting security of supply in Finland and across Europe.
As EU-level discussions on pharmaceutical resilience continue, Fermion's work is a reminder that European manufacturing capacity is not only a policy objective – it is an everyday reality, and patients are already benefiting from it.
