Darnytsia Receives EU GMP Certificate from the Polish Regulatory Authority

Darnytsia Pharmaceutical Company has successfully passed an inspection conducted by the Polish Chief Pharmaceutical Inspectorate (GIF) and has received a certificate confirming compliance with the European Union’s Good Manufacturing Practice (EU GMP) requirements.

The certificate has been issued for a three-year period and covers the production of small-volume sterile solutions.

The inspection was conducted online from September 4 to September 10 and encompassed the company’s manufacturing facilities in Ukraine. Polish inspectors assessed Darnytsia’s quality management system, production processes, and their compliance with European regulatory standards.
 

Following the inspection, Darnytsia received a number of observations and developed a Corrective and Preventive Action Plan (CAPA). The submitted CAPA plan was reviewed and approved by the Polish inspectors.

“This is not a one-time inspection – it is confirmation of systematic and consistent work. The EU GMP certificate demonstrates that Ukrainian pharmaceutical manufacturing operates in full compliance with European quality standards, even during wartime,” commented Olha Kramarenko, Quality Director at Darnytsia.

“Obtaining an EU GMP certificate from Poland is a significant step forward in expanding Darnytsia’s presence in international markets. We already have reliable partners in Europe and will continue to increase the use of Ukrainian medicines within the European Union. This is not only our achievement, but also an important victory for the entire Ukrainian pharmaceutical industry and the country’s economy,” added Hurhen Karapetian, Export & Hospital Sales Director at Darnytsia Pharmaceutical Company. 

Receiving the EU GMP certificate opens new export opportunities and at the same time confirms that Darnytsia is building pharmaceutical manufacturing as strategic infrastructure – reliable, modern, and accessible.