JSC Grindeks oxytocin in the List of Prequalified Medicinal Products was included after 2 years of purposeful work and inspections of manufacturing sites. For the final dosage form (FDF) oxytocin to be prequalified, JSC Grindeks had to receive WHO conclusions that the FDF meets several eligibility criteria. Company had to prepare product dossier with detailed information attesting to the quality, safety and efficacy of the product, and also had to demonstrate that the FDF is stable under climatic conditions prevailing in the country or countries in which the FDF is intended to be used. The stability-testing program and conditions had to correspond with WHO quality guidelines. All necessary tests were carried out for both the active pharmaceutical ingredient (API) the medicine contains and the FDF. Mandatory prequalification related tests were carried out at the sites where the FDF is manufactured – JSC Grindeks Group’s company HBM Pharma in Slovakia and Satonika in Lithuania. The API oxytocin is manufactured in Latvia.
JSC Grindeks Chairman of the Board Juris Bundulis: “Oxytocin inclusion in WHO medicine list gives us new opportunities in WHO organized international tenders for medicines and has once more acknowledged Grindeks ability to be competitive in global scale. We will be able to offer oxytocin in new markets, and that will enhance Grindeks recognition and representation in the international pharmaceutical market. This is an important milestone – an evidence of the high quality of our products and our team professionalism. Grindeks is constantly developing.”
WHO prequalification of FDF provides assurance that the FDF meets international standards of quality, safety and efficacy and WHO Good Manufacturing Practice. In total 76 manufacturers from 29 countries has an FDF or FDFs listed on the WHO List of Prequalified Medicinal Products and 46 manufacturers from 6 countries has an API or APIs listed on the WHO List of Prequalified Active Pharmaceutical Ingredients.
JSC Grindeks sales volume of the FDF oxytocin and API oxytocin in 2018 reached 4.5 million euro.
Oxytocin is a medicine used in medical institutions in obstetrics.