Arterium Corporation's products pass quality compliance assessment for Belarus market
Recently, Ministry of Health of the Republic of Belarus has enacted a resolution, which enables Belarusian regulating authorities to inspect foreign pharmaceutical companies for compliance with the good manufacturing practice (GMP) requirements. Such inspections are conducted if a drug is registered or re-registered in the Belarusian market, or if the production facility making the it was not inspected over the prior 5 years.
Arterium Corporation has been present in Belarus since 2006. Its product portfolio in this market encompasses 54 drugs, and it is among the top 30 companies by sales value. The inspection by Belarusian regulating authorities was prompted by registration of Thiocetam tablets, a new medicinal product for this market, and re-registration of Furagin tablets—both manufactured at Kievmedpreparat, an Arterium Corporation facility. In June, representatives of the Ministry's Centre for Examination and Tests in Health Service inspected the solid form pharmaceuticals production area at Kievmedpreparat.
“GMP compliance verification is always a complicated and important process for any producer. Ukraine is among the first CIS countries to have integrated the GMP requirements into medicinal products manufacturing conditions. Our facility passed the first such inspection back in 2011. We are very pleased to see how professional, informed and familiar with the regulatory system and the EU requirements Belarusian inspectors are,” Serhiy Sur, Arterium Corporation’s Director for Cooperation with Regulators, said.
The facility has successfully passed the inspection, getting a certificate of compliance with GMP requirements of the Republic of Belarus for the of the above-mentioned pharmaceuticals commercially produced at Kievmedpreparat.