The production capacity allows satisfying 100% of Russia's demand for recombinant and analogue human insulins, veterinary insulins, glucagon-like peptide-1 analogues, recombinant human albumin and 200% for recombinant human follicle-stimulating hormone.
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.
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 insulin 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])
Release form: 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.
Finished dosage forms of recombinant human albumin production
Production capacity: enables to satisfy up to 100 % Russia’s necessities of these products.
Production range:
- Recombinant human albumin
Release form: in polyethylene five-layer single-use containers with one sterile port 50/100 ml × 1.
Recombinant human albumin is the world's first registered human albumin drug obtained by the recombinant DNA technology using Pichia Pastoris cells.
