The «Import-Substituting Production of Recombinant and Analog Insulin from Proprietary Substance project» has been under way since 2016 and supported by the Industry Development Fund of the Russian Federation.
The «Medsintez» plant plans to manufacture API of recombinant and analog insulin (Aspart, Glargin) for subsequent use in its own production of finished dosage forms.
In September 2017, own insulin API, Rosinsulin, was registered, at the end of 2018 – the analog insulin API Rosinsulin aspart, a decision by the RF Ministry of Health is expected on adding an analog preparation, Rosinsulin glargine, to the State Register of Medicines.
The implementation of the project will allow to give up purchasing foreign substances and create a full-cycle insulin production. The domestic production of the substances will help reduce prices for finished insulin by 15-20% relative to import prices. The insulins will be produced in the most convenient and familiar finished dosage forms for patients: in cartridges and syringe pens.
For the project, the following have been created at the «Medsintez» plant:
A modern R&D lab for genetics and biotechnology (2014)
A pilot zone (for developing a technology for the production of recombinant drugs, including the API of analog insulin forms) (2015)
RHI API industrial production with capacity up to 400 kg/year (2016-2020)