ICM Farmak Receives First EU GMP Certification for Sterile Manufacturing in Spain
ICM Farmak S.L.U., Farmak International’s Spanish manufacturing facility, has received its first EU Good Manufacturing Practice (EU GMP) certificate following an inspection conducted by the Spanish Agency for Medicines and Health Products (AEMPS), under the Ministry of Health of Spain.
The certification confirms the site’s compliance with EU GMP requirements for the manufacture of sterile pharmaceutical dosage forms, including aseptic filling and terminal sterilization (bulk), supported by GMP-compliant quality control activities. The EU GMP certificate was formally issued and received in December 2025.
The name ICM Farmak reflects the site’s focus on Injectable Critical Medicines — sterile pharmaceutical products intended for use in complex and regulated healthcare settings.
ICM Farmak’s sterile manufacturing facility in Barberà del Vallès, Spain
A first EU GMP certification achieved at speed
For a newly established site, achieving a first EU GMP certification represents a critical regulatory milestone. At ICM Farmak, this milestone was reached within less than two years from site readiness, reflecting a structured and disciplined approach to inspection preparedness.
Preparation focused on establishing a complete quality management system from the outset. This included quality governance, documentation control, and structured training frameworks. Qualification and validation strategies, contamination control, and supplier oversight were implemented as core elements. Together, these foundations ensured that inspection readiness was embedded into daily operations rather than treated as a one-time event.
The long-term success of a company does not depend on the products or services it sells, but on the purpose it pursues. In our case, that purpose is translated into very focused decisions. It shows in how we design the quality system, how we prepare our teams, and how consistently we operate long before any inspection takes place
Kacper Budek Quality Director, ICM Farmak S.L.U
A facility structured for sterile manufacturing and long-term supply
Located near Barcelona, in Barberà del Vallès, the ICM Farmak facility supports EU GMP-certified sterile manufacturing across multiple dosage forms, including vials and pre-filled syringes. The site combines aseptic processing and terminal sterilization capabilities with GMP-compliant analytical, microbiological, and quality control laboratories, enabling end-to-end oversight of sterile manufacturing activities.
In line with EU GMP requirements, the facility also holds regulatory responsibilities related to quality control and the import of finished medicinal products.
Beyond its current certified scope, the site’s structure supports long-term supply planning for regulated markets, allowing for measured scaling and automation in response to evolving partner and patient needs.
Vials on the filling line at the ICM Farmak
A long-term platform for regulated-market partnerships
Commenting on the certification, Viktor Kostiuk, CEO of Farmak International, said:
EU GMP certification is not an endpoint — it is a responsibility that defines how we operate going forward. By building our facility in Spain to meet the highest regulatory expectations from the start, we are creating a long-term platform to support partners in regulated markets and to ensure reliable access to injectable critical medicines
Viktor Kostiuk CEO, President of the Board, Farmak International.
About ICM Farmak
ICM Farmak S.L.U. is Farmak International’s manufacturing facility in Spain, focused on the production of sterile injectable medicines. The site specializes in Injectable Critical Medicines and supports aseptic and terminally sterilized manufacturing, quality control, and international supply for regulated healthcare markets in compliance with EU GMP requirements.
