{"id":34588,"date":"2026-07-22T14:34:19","date_gmt":"2026-07-22T12:34:19","guid":{"rendered":"https:\/\/ichp.lukasiewicz.gov.pl\/2026\/07\/22\/active-pharmaceutical-ingredients-apis-are-a-matter-of-national-security-poland-needs-an-organisation-that-will-take-responsibility-for-them\/"},"modified":"2026-08-05T12:39:05","modified_gmt":"2026-08-05T10:39:05","slug":"active-pharmaceutical-ingredients-apis-are-a-matter-of-national-security-poland-needs-an-organisation-that-will-take-responsibility-for-them","status":"publish","type":"post","link":"https:\/\/ichp.lukasiewicz.gov.pl\/en\/2026\/07\/22\/active-pharmaceutical-ingredients-apis-are-a-matter-of-national-security-poland-needs-an-organisation-that-will-take-responsibility-for-them\/","title":{"rendered":"Active pharmaceutical ingredients (APIs) are a matter of national security. Poland needs an organisation that will take responsibility for them"},"content":{"rendered":"\n
Discussions about medicine safety usually focus on the finished product, such as a tablet. Yet what actually cures the illness is created much earlier. We are talking about the active pharmaceutical ingredient (API). Without it, there would be no tablets, capsules or injections. And it is precisely at this level, at the very heart of the supply chain, that Europe has \u2018lost ground\u2019. <\/strong><\/h5>\n\n

The figures speak for themselves. In 2000, Europe accounted for 42 per cent of global active pharmaceutical ingredient (API) production. Today, that figure stands at just under 10 per cent. Currently, nearly 80 per cent of the APIs used in European medicines come from Asia, primarily from China and India. For years, this was regarded as a natural consequence of globalisation. The COVID-19 pandemic, followed by the war in Ukraine and subsequent geopolitical tensions, have shown just how much this dependence really costs. Added to this are tariffs, export restrictions and trade rivalry between the US and China. A single disruption is enough to cause a shortage of raw materials for medicine production. <\/p>\n\n

Poland: many pharmaceutical factories, but not enough sources of active ingredients<\/strong>
There are many manufacturers of finished pharmaceutical products operating on the domestic market. However, there are far too few manufacturers of active ingredients \u2013 that is, those capable of synthesising APIs from scratch. In Poland, only 33 companies are capable of doing so. In Italy there are 180, and in France 147. From the emerging list of critical medicines, Poland has manufacturing capacity for 19 active ingredients. <\/p>\n\n

Although the \u0141ukasiewicz \u2013 Industrial Chemistry Institute is a scientific and research organisation, it is one of the largest (the second largest in terms of volume) manufacturers of APIs in the country and, for certain substances, one of only two or three suppliers worldwide. The Institute possesses proprietary technologies and the facilities required to manufacture, as well as to rapidly scale up production of, active pharmaceutical ingredients used in medicines on the critical medicines list, including, amongst others, Anastrozole, Clopidogrel, Latanoprost, Oseltamivir, Imatinib Mesylate and Olanzapine. <\/p>\n\n

In some cases, we are among the very best. Sometimes there are only two or three manufacturers of a particular substance in the world. This is not a position we boast about, but one that carries a great deal of responsibility. <\/em> – Wojciech Maszewski<\/p>\n\n

A window of opportunity that must not be missed<\/strong>
For the first time in years, regulations and funding are pointing in the same direction. In March 2025, the European Commission proposed a draft regulation for the Critical Medicines Act, a piece of legislation designed to rebuild Europe\u2019s pharmaceutical manufacturing capacity. It will cover around 280 critical active pharmaceutical ingredients and is set to change the rules on public procurement. Alongside price, security of supply, diversification of sources and production within the European Union will be key considerations. For European API manufacturers, this could be an opportunity to change the conditions under which it has hitherto been difficult to compete with subsidised, cheaper Asian production. <\/p>\n\n

One of the key tools for strengthening the country\u2019s technological potential is the National Recovery Plan. Thanks to funding from the National Recovery Plan, \u0141ukasiewicz \u2013 Industrial Chemistry Institute was able to modernise its production infrastructure and launch CeTeAPI \u2013 the API Manufacturing Technology Centre, which opened in march in the symbolic year marking the 110th anniversary of the institute founded by Ignacy Mo\u015bcicki. <\/p>\n\n

History has come full circle. Over a century ago, Mo\u015bcicki and his colleagues established laboratories on the premise that without a strong scientific base, there could be no lasting economic independence. Today, the circumstances are different, but the aim remains the same: to develop domestic technological capabilities and strengthen the security of strategic supply chains. <\/p>\n\n

What CeTeAPI can do<\/strong>
CeTeAPI brings together research and development facilities and GMP-compliant pharmaceutical manufacturing under one roof. This enables the active substance to undergo the entire development process in a single location: from initial laboratory synthesis, through process scale-up on a pilot plant, right through to a product ready for industrial production. <\/p>\n\n

Such integration significantly reduces the time taken for technology transfer, minimises risk at subsequent stages of development and streamlines cooperation with industrial partners. This solution is still rare, not only in Poland but also on the European market. <\/p>\n\n

The most important feature of CeTeAPI is not the equipment, but the fact that we bridge the gap between the research and production stages. Development work does not end with a report; it is designed to move on to the process, validation and manufacturing stages. <\/em> – Wojciech Maszewski<\/p>\n\n

The centre operates under two complementary models. On the one hand, it develops its own portfolio of strategic substances, such as oseltamivir (a medicine used to treat influenza, for which shortages regularly occur during periods of increased incidence); on the other hand, it offers pharmaceutical companies services relating to the development and implementation of API manufacturing technologies, thereby supporting the domestic and European pharmaceutical sectors. <\/p>\n\n

Regardless of its operating model, CeTeAPI\u2019s value stems from its unique combination of scientific expertise and manufacturing facilities. It is this synergy that enables the company to efficiently translate innovative solutions into ready-to-use technologies and products. <\/p>\n\n

Why are we talking about a strategic role?<\/strong>
Infrastructure and expertise are a necessary but not sufficient condition. Pharmaceutical security will not be achieved through individual projects scattered across the market. What is needed is an entity that will take responsibility for the development and production of active pharmaceutical ingredients on a strategic scale, with its own research facilities, GMP-compliant manufacturing and the ability to replicate the process independently of any external supplier. <\/p>\n\n

This distinction is of fundamental importance for the formulation of public policy in the field of pharmaceutical safety. Genuine local content is not merely a matter of importing an active pharmaceutical ingredient from Asia and using it to manufacture a medicinal product in Poland. In such a model, the key dependency remains at the API supply stage. <\/p>\n\n

True supply chain resilience begins at an earlier stage, namely at the point where the active substances themselves are developed and manufactured. Therefore, success should not be measured solely by the number of medicines produced domestically, but above all by the number of strategic molecules that we are able to develop and manufacture ourselves from scratch. <\/p>\n\n

Funding from the National Recovery Plan and future instruments provided for under the Critical Medicines Act can only lead to a lasting improvement in medicine safety if they support entities with the expertise and infrastructure to develop and manufacture active substances, rather than focusing solely on the final stages of the manufacture and packaging of medicinal products.<\/p>\n\n

How others do it<\/strong>
Poland does not need to devise a model from scratch. Countries that have taken pharmaceutical safety most seriously have followed a similar path: they have designated a specialised body or programme responsible for active pharmaceutical ingredients (APIs), provided it with public funding, and linked it to demand and strategic reserves, production subsidies or preferential treatment in procurement. <\/p>\n\n

United States: API strategic reserve and designated producer.<\/strong> Washington has designated active pharmaceutical ingredients as a strategic resource. The Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) was established \u2013 a reserve not of finished medicines, but of APIs, which have a longer shelf life and can be used to produce various forms of medication. The role of national manufacturer was entrusted to Phlow Corporation, which in 2020 was awarded a contract worth up to US$354 million by BARDA to develop domestic API production at its facility in Richmond, Virginia, using batch and continuous manufacturing technologies in accordance with cGMP standards, in collaboration with Civica. In August 2025, a presidential decree reinforced this approach, mandating the establishment of domestic API reserves for around 26 critical medicines and the creation of a six-month supply of these produced domestically. <\/p>\n\n

India: production subsidies and API parks. <\/strong>Although India is a global powerhouse in the production of finished pharmaceutical products, it still imports over 70 per cent of its active pharmaceutical ingredients (APIs) from China and has identified this as a strategic issue. The response is the Production-Linked Incentive scheme for APIs, with a budget of approximately 69.4 billion rupees (approximately 771 million USD). Under the adopted model, the government provides subsidies for the production of specific active pharmaceutical ingredients manufactured domestically. By 2025, the scheme had covered 33 active pharmaceutical ingredients and intermediates across 48 projects, and domestic manufacturing capacity had been established for 26 of these substances. This is complemented by Bulk Drug Parks \u2013 centrally funded industrial parks with shared infrastructure for API manufacturers. <\/p>\n\n

France: rebuilding production from scratch. <\/strong>France has shown that lost production capacity can be restored. Paracetamol, one of the most commonly used active ingredients, had not been manufactured in France since 2008. As part of the France Relance programme, Seqens, in partnership with Sanofi and UPSA and with government support, has launched a new manufacturing plant (start 2021, commissioning 2023, approx. 10,000 tonnes per year, new continuous synthesis technology). At the same time, EUROAPI, one of Europe\u2019s largest manufacturers of active pharmaceutical ingredients, was spun off from the Sanofi group as a deliberate attempt to build a European leader in this field. <\/p>\n\n

United Kingdom: a national centre of excellence.<\/strong> The model most similar to CeTeAPI is the Medicines Manufacturing Innovation Centre near Glasgow, which is funded by public bodies (UK Research and Innovation, Scottish Enterprise) and industrial partners (AstraZeneca, GSK), alongside a university (the University of Strathclyde) and a specialist operator (CPI). The centre develops modern, including continuous, drug manufacturing technologies and shortens the path from the laboratory to production in exactly the same way as CeTeAPI operates. <\/p>\n\n

A common thread and implications for Poland
The models adopted in different countries differ in their specific arrangements, but are based on the same principles.

Firstly, responsibility for the development and availability of active substances is assigned to specific programmes or institutions, rather than being left solely to market forces.

Secondly, public support is linked to actual production capacity and output, rather than merely to investment commitments.

Thirdly, there are mechanisms in place to stimulate demand and ensure market predictability. In the United States, this role is fulfilled, amongst other things, by strategic reserves; in India, by a system of incentives supporting domestic production; and in Europe, measures promoted by the Critical Medicines Act, aimed at strengthening security of supply and manufacturing capacity, are becoming increasingly important.

The common thread running through these measures is the conviction that the resilience of the pharmaceutical system cannot be built solely on the basis of the lowest price. Security of supply requires a well-considered industrial policy, investment in technological expertise, and the maintenance of domestic capacity to manufacture key active substances.

Poland already has a key element in place \u2013 the CeTeAPI centre at \u0141ukasiewicz \u2013 ICI, which combines the development and manufacture of active pharmaceutical ingredients to GMP standards \u2013 but the remaining links are still missing. In addition to a national list of critical medicines, systemic solutions are also needed \u2013 a mechanism for financing production and a clear definition of the entities responsible for acting as strategic manufacturers.

We need conditions for European API manufacturers similar to those being introduced by the United States, for example, as part of its reindustrialisation drive. Today, Asian competitors are subsidised in a way that cannot be offset by efficiency alone. This is not a business issue, but a matter of pharmaceutical safety and the stability of the entire healthcare system. <\/em> – Wojciech Maszewski<\/p>\n\n

Two avenues of cooperation<\/strong>
The Institute proposes a partnership with policymakers and the administration to build national API manufacturing capacity: from participation in the development of a list of critical medicines, through the use of National Recovery Plan (KPO) funds and EU instruments, to specific projects for the production of strategic substances.

It offers pharmaceutical companies its own portfolio of active substances and contract technology development through a European partner operating to GMP standards, with predictability, deadlines, quality and on-site audits, free from geopolitical risk. In doing so, the Institute focuses on substances that are difficult to manufacture and on complex syntheses which manufacturers without a strong scientific background are unable to stabilise. This is where our competitive advantage lies.

Without its own medicines, the European healthcare system remains powerless. The active ingredient is where this independence begins. Poland has a facility capable of developing and manufacturing it, from the molecule to the finished product ready for use. Others have shown how to turn such a centre into a permanent pillar of national security.

Now a decision is needed to do the same in Poland.<\/p>\n\n

\"\"<\/figure>\n\n

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