About Us

"Sphera Pharma" LLC was created in 2008. Since 2011, the company has been a member of the "Pharmaceuticals, biotechnology, and biomedicine" cluster of Kaluga region, that was given the status of a pilot innovative territorial cluster of RF by the Resolution of the Government of the Russian Federation N188 dated March 6, 2013. At present, the company has completed the licensing process for infusion, parenteral nutrition and peritoneal dialysis solutions production plant complying with GMP requirements.

The main goals of the company are:

  • Manufacture of sterile medicinal products to provide import substitution
  • Production of amino acid based drugs almost without analogs on the territory of the Russian Federation
  • Production of systems for peritoneal dialysis
  • The release of blood products widely used in medical practice

The high efficiency, high quality and low cost of the drugs scheduled for release provide all the prospects for significant substitution of imported and domestic counterparts in the pharmaceutical market of Russia and, in addition, for saturation of the existing deficit.

Key advantages:

  • Implementation of processes of blow/formation-filling-sealing of polymeric containers (bottles, bags) in one device
  • Elimination of the product contamination
  • Elimination of penetration of the human factor in the working area
  • The possibility of manufacturing bottles / packages of all sizes (0.1 to 2 L) in one machine
  • The technology of sealing the amino acid solutions in inert gas media. To obtain stable amino acid solutions, the bottle/bag should be purged with an inert gas and oxygen should be removed from the solution directly before filling and sealing. As of today, no domestic factory in Russia applies such technology

Thus, the company is virtually the only one in Russia with the technological capabilities to produce solutions for peritoneal dialysis and amino acid parenteral solutions in large lots, therefore the project is of national importance.

Organization of production of these products will provide the Russian MPI with inexpensive modern drugs, significantly improving the quality of medical services.

A project of a laboratory research complex that would meet the GLP requirements takes a special place in the company development strategy. Its functions include the development of the new drugs production control methods, preparation of manufacturer's monograph for drugs developed, pre-clinical trials of medicinal products, separation of biological models, as well as the organization of clinical trials with the preparation of a "dossier" for their registration.

The activities of the research complex will cover proprietary drugs and those examined by the laboratory under commercial contracts with domestic and foreign pharmaceutical companies.

THE PLANT RATED CAPACITY:

  • 26.9 mln plastic bottles (250, 500 ml) per year;
  • 13.4 mln polymer bags (500, 1000 ml) per year;
  • 4.6 mln polymer bags (2000 ml) per year.
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