A close-up of pink and white capsules spilled from a bottle, depicting pharmaceuticals and medication.

1,500 pharmaceutical products on hold: The need for adjustment in Europe’s pharmaceutical value chain

Supply shortages of pharmaceutical products are occurring with increasing frequency in Europe. Data from the Austrian Agency for Health and Food Safety (AGES) show an increase in Austria from 323 affected pharmaceutical products in 2019 to over 1,500 in 2023.
This development is related to structural changes in pharmaceutical production. Over extended periods, manufacturing was increasingly relocated to low-wage regions in the interest of cost optimisation. In parallel, regulatory requirements in Europe have grown, including requirements such as EU GMP Annex 1 as well as serialisation, which now constitutes an obligation to strengthen patient protection.
This results in a combination of dependencies on third countries and limited regional production capacities.

Site development in Traiskirchen
At the Traiskirchen site, Complex Pharmaceuticals is expanding capacities in the areas of secondary packaging and contract manufacturing. The infrastructure is designed to accommodate varying production requirements as well as variable batch sizes. Development is taking place in both technological and organisational terms. Completion is planned for mid-2026. The technical design is based on modular plant concepts, which enable switching between different formats and batch sizes within an integrated production system.

Dosage forms processed
Processing encompasses various dosage forms and requirements:

  • ampoules and vials for injectable applications
  • infusion bags for clinical use
  • medical devices for use by patients or healthcare professionals
  • storage of products at refrigerated and ambient temperature

The processes are designed for varying production volumes, from smaller units for clinical applications through to the largest volumes for market supply. The goal is to reduce downtime between production runs and to maintain a consistently flexible production architecture.

Technological implementation and personnel
Production takes place using automated systems and digital process control. These enable the documentation of process steps as well as the implementation of control mechanisms during ongoing operations. Digital systems support traceability and contribute to compliance with regulatory requirements. Job creation is planned at the site. Over 60 positions are to be created by 2028.

Conclusion
The developments described encompass changes in global production structures, regulatory frameworks and the expansion of individual processing and packaging capacities. Measures such as mandatory stockpiling have been implemented since April 2025 and affect the availability of pharmaceutical products. The expansion of regional capacities is taking place in parallel within existing value chain structures.