Ukrainian Quality Without Borders: Darnytsia Receives Approval from Kazakhstan’s Regulator

Darnytsia Pharmaceutical Company is moving confidently forward—this time, the team achieved another international victory by successfully passing the inspection of the State Regulatory Authority of Kazakhstan for compliance with the EAEU (Good Manufacturing Practice) GMP requirements.

All production processes, sterile and non-sterile manufacturing, the quality system, documentation protocols, and control measures were thoroughly analyzed by inspectors according to EAEU GMP standards.

The inspection was completed without a single critical or significant remark and confirmed that Darnytsia’s production of sterile and non-sterile medicines fully complies with the strict requirements of the modern pharmaceutical industry, ensuring quality and safety for patients.

This achievement opens up additional opportunities for Darnytsia in the Central Asian markets, further strengthening the company’s status as a reliable supplier of European-level medicines.

“Every new market is another test for our standards and values. The Kazakh inspection has been a valuable experience and further confirmation that Ukrainian medicines are worthy of trust in any country. Moreover, confirmation of EAEU GMP standards potentially expands our access to the markets of Armenia and Kyrgyzstan,” noted Hurhen Karapetian, Export & Hospital Sales Director at Darnytsia Pharmaceutical Company.

“International inspections always set high demands for the team and every detail in our processes. Each positive assessment gives us even more confidence that we have chosen the right path. We are proud to guarantee quality for our partners in different countries,” adds Quality Director Olha Kramarenko.

Ongoing investment in manufacturing, openness to modern challenges, and an uncompromising approach to quality are what allow Darnytsia to strengthen its leadership and expand the geography of trust in Ukrainian pharma.