JSC Tallinn Pharmaceutical Plant (Estonia) and HBM Pharma (Slovakia) have received Russian Good Manufacturing practice (GMP) certificates.
Quality director of JSC Grindeks, Dr.chem. Juris Hmeļņickis points out that receiving GMP certificates is a positive development for the whole Grindeks Group and it will contribute to export to Russian market in 2017 and hereafter.
This certificate confirms high culture of the company’s manufacturing and shows that the company’s quality system is properly planned and implemented, as well as the certificate is a guarantee of quality medicines. European Union GMP certificates for both Grindeks subsidiaries were acquired a long time ago and that allowed export of products to many countries outside the EU, including Russia. The situation has changed since 2016 and foreign pharmaceutical manufacturers who wish to distribute their products in the Russian Federation are obliged to receive Russian GMP certificate, otherwise the registration of new preparations would be impossible. Also, since 1 January 2017, manufacturers who have not received this certificate cannot re-register drugs that are already on the market.
“Inspection representatives from Russia carried out inspections in JSC Tallinn Pharmaceutical Plant and HBM Pharma, spending three days in each of them and concluded that quality standards of products fully comply with Russian GMP standard requirements,” tells J.Hmeļņickis, “we can be proud of the fact that both our factories passed the inspection, because not all foreign medicine manufacturers managed to achieve such good results. It is clear that a decision on the compulsory introduction of such a certificate has been focused on the development of Russian domestic market, hence we perceive it as another obstacle, which we managed to successfully overcome without prejudice to export volumes.” GMP certificate is issued for three years and will be valid until 2019.
JSC Tallinn Pharmaceutical Plant is currently specializing in ointment manufacturing and is equipped with new facilities that allow increasing manufacturing capacity and quality of products. Within the product range of manufacturing plant there are unique ointments that are popular among patients and healthcare specialists – Viprosal B® and Capsicam®.
HBM Pharma was established in 1992 and its manufacturing processes comply with the EU requirements of GMP standards. Manufacturing capacity of HBM Pharma is 60 million ampoules and 400 million tablets per year.