NovaMedica Innotech R&D center meets Russian GMP standards

28 December 2017

GMP News

Novamedica, a Russian pharmaceutical company and investment project of RUSNANO, announced that it received the conclusion of the Russian Ministry of Industry and Trade on the compliance of the production site of NovaMedica Innotech R&D center, a subsidiary of NovaMedica, with the Russian Good Manufacturing Practice (GMP) standards.

The certificate issued following a comprehensive audit conducted by the commission of the Ministry of Industry and Trade of the Russian Federation, confirms that the processes of development, manufacturing and quality control in NovaMedica Innotech are organized in accordance with high quality standards, and the production of tablets, soft and hard gelatin capsules and pellets at its production facilities meets the Russian GMP requirements.

“From now on, NovaMedica R&D center will be able to offer its partners a range of services that are rather rare in the Russian market, including the development and manufacturing of complex medicinal products by using, among other things, the technologies that are unique in the Russian market, such as hot extrusion and spheronization of granules, pellet coating in fluidized bed. I am sure that the positive conclusion of the experts on the compliance of production capacity at NovaMedica Innotech with the GMP requirements will provide an additional argument for our partners in their decisions on selecting the sites for contract development and manufacturing in Russia,” said Alexander Kuzin, the General Director of NovaMedica.

The future plans of NovaMedica R&D center include obtaining the international GMP certificate.

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