26 December 2017
Moscow, December 26, 2017 – Russian pharmaceutical company NovaMedica, investment project of Rusnano, informed about receipt of conclusion of the Ministry of Industry and Trade of the Russian Federation over compliance of the facility of the R&D Center of NovaMedica Innotech (subsidiary of NovaMedica) with the Russian standards of the Good Manufacturing Practice (GMP). The certificate issued basing on the integrated audit of the MIT RF commission, proves that the processes of development, manufacturing and quality control at NovaMedica Innotech are organized in accordance with the high standards of quality and manufacturing of tablets, soft and hard gelatin capsules and pellets at its manufacturing facilities meet the Russian GMP requirements.
«Now R&D Center will be able to provide partners with rather rare in the Russian pharmaceutical market set of services that includes development and manufacturing of complex drug products including with usage of exclusive for our market technologies such as hot extrusion, spheronization of granules, covering of pellets in a liquid bed. I am sure that positive conclusion from the experts regarding compliance of the manufacturing facility of NovaMedica Innotech with the GMP requirements will serve as an additional reason for our partners in making decision over selection of a CMO site for development and manufacturing in Russia”, noted Alexander Kuzin, CEO of NovaMedica.
Further plans of the R&D Center of NovaMedica include receipt of the international GMP certificate.
NovaMedica is a modern Russian pharmaceutical company founded in 2012 by Domain Associates LLC, leading U.S. venture capital firm, and RUSNANO, JSC. NovaMedica's strategy is aimed at search, registration and localization in Russia of intellectual property rights for innovative pharmaceuticals products and technologies, as well as at development and implementation of own R&D projects
NovaMedica became key partner of Pfizer in Russia in 2016. Within this partnership NovaMedica started construction of the pharmaceutical GMP manufacturing facility in the Kaluga region in May 2017. In December 2017 Interdepartmental Commission approved NovaMedica’s application for SPIC to create new pharmaceutical manufacturing facility in the Kaluga region.
In April 2017 NovaMedica opened the Technological Center with state-of-the-art technological capabilities which were previously unavailable in the Russian pharmaceutical industry. In Q4 2017 R&D Center of NovaMedica received manufacturing license and the Russian GMP certificate from the Ministry of Industry and Trade of the Russian Federation.
NovaMedica possesses a well-developed infrastructure for promotion and sale of pharmaceutical products. Currently company is promoting a portfolio of 25 ophthalmological and gastroenterological products in the Russian market.Print
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