Farmak International Successfully Completes Aseptic Process Simulation at Spanish Manufacturing Site
Farmak International has reached a major milestone in the development of its Smart Injectables Production Site near Barcelona, Spain, by successfully completing the first validation of Aseptic Process Simulation (APS).
This achievement confirms that the facility meets EU-GMP Annex 1 requirements for sterile pharmaceutical manufacturing and brings the company one step closer to full certification and operational readiness.
With significant investment, the newly completed manufacturing site is designed to meet the highest pharmaceutical standards. The facility features:
• A full-cycle sterile medicine production plant that complies with European GMP standards.
• Two aseptic production lines for injectables in vials and syringes.
• Advanced automated engineering systems, including BMS (Building Management System).
• A multifunctional laboratory complex for analytical and microbiological control, as well as an R&D center aligned with EMA and FDA requirements.
Successfully passing the APS validation demonstrates the strength of our processes, our team’s expertise, and our commitment to maintaining the highest quality standards in sterile production. With this milestone, we are progressing toward the final certification of our Spanish facility, which will allow us to expand our global reach in injectables and supply life-saving medicines to even more markets
Viktor Kostiuk CEO of Farmak International
The 2025 phase of the project focuses on regulatory inspections, licensing, EU GMP certification, technology transfers, and product registrations. Additional investments are planned for final equipment upgrades and regulatory processes during the year.
Our Spanish site will significantly enhance our injectable product portfolio, ensuring a reliable supply of critical medicines such as anesthetics, antithrombotics, systemic hormones, psycholeptics, cardiovascular agents, and antipsychotics. This expansion strengthens our ability to serve global healthcare providers with high-quality solutions
Ihor Chernysh CEO ICM Farmak S.L.U.
With the successful APS validation, Farmak International takes a significant step forward in delivering cutting-edge injectable pharmaceuticals while reinforcing its commitment to quality, safety, and innovation.
For more information, please contact: info@farmak.ch
