Petrovax Pharm will export Polyoxidonium® tablets to Slovakia
Petrovax Pharm will export Polyoxidonium® tablets to Slovakia. The company has received an updated EU Good Manufacturing Practice (GMP) certificate, which now covers the production of tablets in addition to lyophilized products. Issued in September 2026 following an inspection by Slovakia’s State Institute for Drug Control (SIDC), the certificate confirms that the company’s manufacturing operations and quality system comply with European requirements.
Polyoxidonium® has been available in Slovakia as a lyophilized formulation for more than 15 years. Demand for the medicine is high: per capita consumption in Slovakia is four times that in Russia. The new certificate will enable the company to expand its export range to include tablets.
EU GMP certification creates additional opportunities for Petrovax Pharm to expand exports to the Middle East, Africa and Southeast Asia. In a number of countries, EU GMP certification can simplify regulatory procedures, shorten timelines for marketing authorization and, in some cases, eliminate the need for a repeat inspection of the manufacturing site. The example is the marketing authorization of Polyoxidonium in Botswana (southern Africa) in summer 2026.
“Compliance with international GMP standards reflects the consistent efforts of our entire team and continuous quality control at every stage of production. Successfully passing the European inspection and extending certification to tablets demonstrate the high standards of our manufacturing processes and create new opportunities to expand international supplies,”
Petrovax Pharm’s modern biopharmaceutical manufacturing complex is located in the Moscow Region and operates in accordance with the GMP standards of the Eurasian Economic Union (EAEU) and the European Union (EU). In 2012, it became the first pharmaceutical manufacturing facility in Russia to receive EU GMP certification. Since then, the company has regularly confirmed its manufacturing compliance with European quality standards.
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