Progress in the Implementation of Annex 1 GMP

Great progress on our path to excellence!

We are pleased to share a very important milestone for the pharmaceutical production side: we have successfully completed the first major filter retrofit in the Manufacturing Areas, achieving Grade A in the new critical equipment zone of Manufacturing Room III, as set out in Annex 1. The same upgrade will be carried out in Manufacturing Room VI during Q4 2025, as the last major plant upgrade.

In addition, we have completed the validation of our first disinfectant and are in the final stages of validating the latest room disinfection products. With this, we have successfully completed all corrective actions under the CAPA Annex 1 plan, ensuring full compliance with current regulations.

These improvements not only ensure regulatory compliance, but also strengthen our commitment to producing sterile medicines under the highest standards of quality and safety.

This achievement is a reflection of the effort, dedication, and vision of the entire team. Every step we take brings us closer to our purpose: bringing health, confidence, and innovation to those who need it most.