Pursuant to the Order of the Russian Ministry of Industry and Trade, Petrovax Pharm was issued certificates of conformity to the Russian GMP rules (Nos. GMP-0081-000103/16 and GMP-0081-000104/16).
All manufacturing processes for sterile pharmaceuticals (liquid dosage forms and lyophilizates), nonsterile medicinal products (suppositories and tablets), vaccines, immunomodulators, and APIs have been certified for GMP compliance.
“Successful passing of the Russian certification audit is a proof of the high standards of the company’s pharmaceutical manufacture and quality management system, as well as additional opportunities for strengthening our export potential. Presently, Russian GMP certificates are acknowledged by the EAEU member states, and Iran, and such certification opens new prospects for our company’s development on foreign markets,” emphasized Petrovax Pharm President Elena Arkhangelskaya.
NPO Petrovax Pharm LLC is a Russian developer and manufacturer of innovative pharmaceuticals and vaccines. The company’s key focus areas are manufacturing of influenza and pneumococcal vaccines for the National Immunization Schedule as well as the development and production of immunobiologicals.
Petrovax Pharm’s manufacturing facility located in Moscow region has been certified for compliance with the Russian and international GMP standards as well as ISO:9001. The facility provides for manufacturing more than 160 m doses of immunobiologicals per annum.
Petrovax Pharm has more than 600 employees. This is an Interros Group company, with the facility’s controlling interest owned by Vladimir Potanin’s company. Mr. Potanin is Interros Group founder and owner.