The Center will address the issue of dependence of Russian drug manufacturers on foreign reference samples and will promote the development of the national pharmacopoeia. The design and estimate documentation of the enterprise will be prepared by FAVEA, a European engineering company. The Center will be located in Moscow at the Research institute for biosynthesis of protein substances.
The Center established by Nacimbio will produce reference samples of pharmaceutical substances, impurities, as well as biological molecules and organisms required for quality control of medicines. After the center operations will reach the full production capacity, the expenditures for purchasing samples will be reduced, the terms of their delivery to domestic manufacturers and to the system of federal surveillance in the sphere of drug circulation will be shortened.
“It is impossible to talk about import substitution in pharmaceutical industry without the localized production of pharmacopoeial reference samples. We can localize production of any drug, but no one would need it without comparing with a reference standard and without quality control,” said Maryam Khubieva, CEO of Nacimbio. “Our project will address the issue of dependence of Russian manufacturers on foreign suppliers of reference standards.”
“Today, there are no production sites in Russia, that are similar to the future Scientific Pharmacopeia Center of Nacimbio. We are happy to participate in this project, which is extremely important for the development of pharmaceutical market,” said David Mishka, CEO of FAVEA Group. “For FAVEA, the top priority is always the high quality of services and commitment to long-term collaboration with customers.”