Production
Steps
Obtaining an isotope
Synthesis
Sterilization
Packing
Quality control
Transportation
01
Obtaining an isotope
The production of a radiopharmaceutical begins with obtaining the radioactive isotope fluorine-18 (18F), which is carried out on charged particle accelerators — cyclotrons.
02
Synthesis
The obtained isotope 18F is transferred to the synthesis module located in the radiochemical laboratory, where it is introduced into the chemical structure of the molecule, which has the necessary physiological activity.
03
Sterilization
This results in a semi-finished product, which is purified from impurities, sterilized and used to obtain the finished dosage form.
04
Packing
The finished radiopharmaceutical is packaged in aseptic conditions in vials (bottles).
05
Quality control
A part of the finished product is necessarily sent to the quality control laboratory. The pharmaceutical is allowed into circulation only after confirmation of compliance of the declared quality indicators with the requirements of the state pharmacopoeia.
06
Transportation
The radiopharmaceuticals produced by the company have a short shelf life of only 14 hours and a short half-life of 109 minutes
Radiopharmaceuticals are transported in special certified transport packaging kits (UKT). UKT consists of a tungsten shielded container and external case.
This UKT design ensures complete safety for the environment, personnel and the population.
Delivery to PET/CT medical locations
Our own production sites are located in Ufa, Yelets, Stavropol,
Novosibirsk and Pavlovskaya town in Krasnodar Region.
Partners' production sites are in Balashikha, Chelyabinsk, Kazan.
Pharmaceuticals are supplied daily to more than 35 diagnostic centers.
Balashikha
Yelets
Kazan
st. Pavlovskaya
Ufa
Stavropol
Chelyabinsk
Novosibirsk
About the pharmaceuticals
In production
18F-FDG
Is a glucose molecule in which one of the hydroxyl groups is replaced by the radioactive isotope Fluorine-18. It is possible to examine almost the entire human body with the help of the pharmaceutical.
More details about the pharmaceutical
Expecting RF approval
18F-FET
A pharmaceutical for the diagnosis of brain tumors. A complex of a conditionally essential amino acid and the radioactive isotope Fluorine-18.
More details about the pharmaceutical
Expecting RF approval
18F-PSMA
A pharmaceutical for the diagnosis of prostate cancer, both primary and recurrent/metastatic.
More details about the pharmaceutical
Our standard
All the processes at the production sites of RadioMedSynthesis and at partner production facilities, from the selection, purchase, transportation and storage of raw materials to the transportation of the finished product and transfer to the medical center, comply with the requirements of the Rules of Good Manufacturing Practice (GMP). The team of technologists, physicists, analytical chemists, and quality assurance staff is represented by highly qualified specialists who are trained in leading professional organizations in the Russian Federation and are regular participants in international and Russian conferences.