Petrovax Pharm confirms compliance with EU GMP standards
The pharmaceutical manufacturing complex of Petrovax Pharm has confirmed that its production facilities and quality management system (QMS) comply with EU Good Manufacturing Practice (GMP) requirements. The GMP certificate was issued following an inspection audit conducted by the State Institute for Drug Control (SIDC) of Slovakia. Obtaining this certificate enables the company to continue product supply to Slovakia and opens new opportunities for expanding exports within the European Union.
Petrovax Pharm’s modern production complex, located in the Moscow region, operates in accordance with both EAEU and EU GMP standards. The site carries out pharmaceutical substance synthesis as well as the production of sterile and non-sterile medicinal products in various dosage forms. Petrovax Pharm became the first Russian biotechnological company to receive an EU GMP certificate in 2012.
In 2025, for the first time in many years, the enterprise underwent a full-scale EU GMP audit, which included comprehensive preparation, submission of complete documentation package, and on-site inspection. The successful completion of the audit confirmed that the company’s manufacturing processes fully meet strict European requirements.
For more than 15 years, Petrovax Pharm has exported its product Polyoxidonium® to Slovakia, where it is in high demand. Per capita consumption of the product is four times higher than in Russia. The company is also exploring opportunities to expand its export portfolio.
The GMP certificate obtained in 2025 strengthens Petrovax Pharm’s position in the Slovakian market, supports the stability of ongoing supplies, promotes export growth across EU countries, and facilitates access to the company’s medicines within the European market.
