Recombinant and analogue human insulins API production

The production building area of recombinant and analogue human insulins API is 2000 m2. A complex of clean rooms with an area of 960 m2, including C and D clean-grade rooms. Production capacity - 200 kg of the API per year.

The «Import-Substituting Production of Recombinant and Analogue Insulin from Proprietary Substance project» has been under way since 2014 and supported by the Industry Development Fund of the Russian Federation.

The «Medsintez» plant plans to manufacture API of recombinant and analogue insulin (Aspart, Glargine) for subsequent use in its own production of finished dosage forms.

Own insulin APIs were registered: In September 2017 – «Rosinsulin» (RHI), in December 2018 – the analogue insulin «Rosinsulin aspart» and in December 2020 the analogue insulin – «Rosinsulin glargine» (100 IU/ml).

Finished dosage forms were registered: in December 2020 – «Rosinsulin Medsintez» and «Rosinsulin aspart R», in December 2021 - «Rosinsulin glargin 300 Medsintez» (300 IU/ml), in March 2023 – «Rosinsulin glargine» (100 IU/ml).

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 analogue insulin forms) (2015)

RHI API industrial production with capacity up to 200 kg/year (2017-2023)

Recombinant human follicle-stimulating hormone API production

The production building area of recombinant human follicle-stimulating hormone API is 564 m2. A complex of clean rooms with an area of 290 m2, including C and D clean-grade rooms. Production capacity - up to 30 grams of the substance per year.

Since 2018, Medsintez has implemented another biotechnological project for the production of the latest development in the field of reproductive technologies in cooperation with iVPharma: the enterprise has produced the substance of recombinant follicle-stimulating hormone and produced the first Russian drug for the treatment of human infertility – Primapur. It is used in the in vitro fertilization (IVF) procedure to induce the growth of follicles in the ovaries. The preparation is successfully used in clinics throughout Russia.

A fully Russian drug; it went through all stages, from the development and creation of a pharmaceutical substance to the release of a finished dosage form, exclusively in the Russian Federation. Primapur® is included in the list of vital drugs.

The Russian-made FSH preparation is necessary for modern medicine in the Russian Federation on the way to overcoming the reproductive problems of the population. Within the framework of the Federal Law of November 21, 2011 No. 323-FZ "On the Fundamentals of Protecting the Health of Citizens in the Russian Federation", citizens are widely provided with affordable infertility treatment using the IVF procedure.

High-tech Russian production at the Medsintez plant ensures the world-class quality and safety of manufactured medicines. At the same time, the domestic production of FSH does not depend on fluctuations in exchange rates, which means it offers a favorable price for the finished drug in comparison with imported analogues.

Solving the issues of import substitution, the company conducts research and development work to prepare for the production of other hormonal preparations necessary for the IVF procedure. New medicinal products of human chorionic gonadotropin and human gonadotropin-releasing hormone antagonist are currently at the stage of preliminary work before being submitted for registration with the Russian Ministry of Health. At the moment, the production of such drugs in the Russian Federation is especially important in order to ensure the availability of IVF treatment methods and the uninterrupted supply of drugs to the medical centers of our country.

If necessary, this production area is capable of producing any import-substituting preparations based on monoclonal antibodies.