Darnytsia Passes Polish Regulator Inspection

Darnytsia Pharmaceutical Company has successfully passed an inspection by the Polish regulatory authority and has been recommended for certification attesting that the ampoule production lines comply with European Good Manufacturing Practice (GMP) standards.

Polish inspectors thoroughly examined all stages of production and quality control in the ampoule department, as well as quality management system processes, contamination control strategy, documentation, and internal procedures in accordance with the strict European GMP standards.

The inspection covered all key manufacturing processes and confirmed that the sterile production at Darnytsia fully meets GMP requirements, ensuring the quality and safety of its products.
Passing this inspection is an important step in expanding Darnytsia’s presence on the European pharmaceutical market.

“Entering new markets is our everyday work. Passing the Polish GMP inspection proves that our Ukrainian medicines meet the strictest European requirements. Each such international recognition is a shared success and another proof that Darnytsia is confidently moving forward,” says Hurgan Karapetyan, Director of Export and Hospital Sales at Darnytsia Pharmaceutical Company.

“European inspections are truly a valuable experience, as they always involve high standards and attention to every detail. We especially appreciate the professional and constructive approach of our Polish colleagues. Such inspections not only offer new opportunities for cooperation and entry to EU markets, but also confirm that the quality of Darnytsia’s products meets European standards. We are proud to guarantee our partners and patients genuine European quality with our medicines,” adds Darnytsia’s Director of Quality, Olha Kramarenko.