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. Furthermore, the filling line is automatically cleaned and sterilized after each production batch.

Solution Preparation Area

Inspection machines check each cartridge for particulate matter and other defects.

Since human insulins are protein-based and cannot withstand high temperatures, they cannot be sterilized. Therefore, the production involves aseptic filling.

In accordance with the design, production premises comprise a number of cleanrooms (including the highest Class A) that ensures a germ-free environment. Clean zones feature continuous monitoring of supply air purity, while the filling area and its surroundings are equipped with automated monitoring of airborne microparticles.

Prior to filling, all solutions undergo double sterilizing filtration, and all primary packaging materials (vials and cartridges, as well as closures) undergo thermal sterilization in special autoclaves.

The use of multiple redundant protection mechanisms against environmental and human factors ensures production of high-quality and safe pharmaceuticals.

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.

Production range:

• ROSINSULIN R Medsintez (INN Soluble insulin [human recombinant])
• ROSINSULIN S Medsintez (INN Isophane insulin [human recombinant])
• ROSINSULIN M mix 30/70 Medsintez (INN Biphasic insulin [human recombinant])
• ROSINSULIN ASPART R (INN Insulin aspart)
• ROSINSULIN GLARGINE (INN Insulin glargine)

Release form: cartridges, vials, disposable pre-filled injection pens.

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.

Production range:

• Primapur® (INN Follitropin alfa)

Release form: disposable pre-filled injection pens.

Primapur® is the first Russian drug of follitropin alfa for human infertility treatment.

Finished dosage forms of insulins and follicle-stimulating hormone for veterinary use production

Production capacity: enables to satisfy up to 100 % Russia’s necessities of these products.

Production range: 

• VINSUVET Glargine ANIMALPEN for cats (INN Insulin aspart)
• VINSUVET mix 30/70 ANIMALPEN for dogs (INN Biphasic insulin [human recombinant])
• VINSUVET Glargine (INN Insulin aspart)
• VINSUVET mix 30/70 (INN Biphasic insulin [human recombinant])
• VINSUVET-FSH (INN Follitropin alfa)

Release form: vials, disposable pre-filled injection pens.

Veterinary insulins of the VINSUVET series are the first domestic drugs for the treatment of diabetes mellitus in cats and dogs.

Finished dosage forms of hypoglycemic drugs - glucagon-like peptide-1 analogues production

Production capacity: 14-15 million disposable injection pens enables to satisfy up to 100 % Russia’s necessities of these products

Production range: 

• Enligria® (INN liraglutide)
• Quincenta® (INN semaglutide)

Release form: disposable pre-filled injection pens.

Enligria® is the first Russian analogue of glucagon-like peptide-1 (aGLP-1).

Quincenta® is the first domestic semaglutide with a full production cycle in the Russian Federation.