The production building area is 4000 m2. A complex of clean rooms with an area of 386 m2, including A, B, C, D clean-grade rooms. The production capacity - 10 billion International Units per year.

The production capacity allows satisfying 100% of Russia's demand for recombinant and analogue human insulin preparations and 200% for recombinant human follicle-stimulating hormone preparation.

Put in commission in February 2008. 

The production site design was examined for compliance with European GMP requirements by UK specialists.

The equipment has been purchased in Germany, from companies which supply similar equipment to the world's biggest insulin manufacturers - Novo-Nordisk, Eli Lili, Sanofi-Aventis.

The bottling line (made in Germany) has a unique design; it operates in an automatic mode and requires only monitoring the process. Bottles and cartridges are washed, rinsed, sterilized, filled and sealed without any human intervention. This kind of automation makes it possible to fully protect insulin preparations from any environmental effects and a human factor. Additionally, once filling is over, the filling line can be automatically rinsed and sterilized too.

The insulin solution preparation zone is fully computerized; people can affect the process only by installing appropriate programs. The zone has been designed and manufactured by a German company's specialists possessing unique experience in this field. 

The inspection machines, which are made in Japan and Italy, are able to examine each bottle and cartridge for mechanical impurities.

Since human insulins cannot withstand high temperatures and cannot be sterilized in an autoclave, the project provides for aseptic adding of the drugs.

Clean zones (A grade) have been designed and built in such a way that not a single microorganism is allowed per cubic meter of the production area air. In these zones, the supplied air is constantly monitored for purity.

Before filling, all insulin preparations are sterilized by means of the double sterilizing filtration. And only solutions which are already sterile are poured into sterile bottles or cartridges.

Using multiple methods to protect a drug from environmental and human exposure makes it possible to produce high-quality and safe recombinant and analogue insulins.

Finished dosage forms of recombinant and analogue human insulins production

Production capacity: 10 billion IU per year, which allows to satisfy 100% of Russia's demand for insulin preparations.

The workshop's product range:

• ROSINSULIN R Medsintez;
• ROSINSULIN S Medsintez;
• ROSINSULIN M mix 30/70 Medsintez;
• ROSINSULIN ASPART R;
• ROSINSULIN GLARGINE.

The preparations come:

• in cartridges (3 ml)
• in bottles (5 ml)
• in disposable pre-filled syringe pens (3 ml)

Rosinsulin® disposable pre-filled syringe pens have been designed for administering ROSINSULIN R Medsintez, ROSINSULIN C Medsintez, ROSINSULIN M mix 30/70 Medsintez, ROSINSULIN ASPART R, ROSINSULIN GLARGINE insulin products.

Using disposable pre-filled syringe pens allows the patient to:

• make the insulin injection procedure comfortable and easy;
• inject high, medium and small doses of insulin accurately;
• avoid the problem of injecting an inaccurate dose due to gradual wear of a syringe pen;
• absolutely strictly follow the treatment regimen

Manual instructions for ComfortPen ROSINSULIN syringe pen

Finished dosage forms of recombinant human follicle-stimulating hormone production

Production capacity: up to 1 million disposable syringe pens, which makes up 200-250% of the existing Russian market.

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.

The Medsintez plant developed and was the first in Russia to produce the domestic most convenient and most demanded by consumers form of FSH release - syringe pens. The pen syringe during the phase III clinical trial of Primapur® was recognized by the patient as convenient, which allows the drug to compete properly with foreign manufacturers.

The Medsintez plant produces the drug in the form of a handy disposable pen injector available in three different dosages: 300, 450, 900 International Units (IU). The syringe pen has been designed for maximum convenience for patients and accurate dosage selection by specialists. It allows adjusting the administered dose of the drug with the minimum known increments of 5 IU of its activity. The syringe pen used with Primapur® has been registered by Roszdravnadzor as a medical device.