Siberian State Medical University (SibSMU) in Tomsk has received a certificate of compliance with the good manufacturing practice (GMP) of the Eurasian Economic Union (EAEU). This allows the university to organize the production of Active Pharmaceutical Ingredients (APIs) for civilian circulation, according to a statement from SibMed’s press service.
The extension of certification, which enables the university to introduce developed APIs into mass production, will help in concluding agreements with industrial partners for the manufacture of human use medical products for broad application.
“Obtaining the new EAEU GMP certificate and the license extension is a strategic result of our systematic work within the ‘Priority-2030’ program. We have been purposefully creating not just a research center, but a full-scale production ecosystem: from a fundamental idea and pre-clinical research to the release of substances for real-world healthcare application,” said SibMed Rector Evgeny Kulikov.
At the same time, the university passed a pharmaceutical inspection by the Ministry of Industry and Trade and received the right to produce APIs of biological origin.
As previously reported, Sechenov University and Novosibirsk State University have agreed to create a joint West-East clinical research center. You can read more about the project in the GxP News article.
