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Commercial Production of Radiopharmaceuticals

Our product range includes the manufacturing and quality control of medicinal substances and products for clinical testing. UJV Rez supplies the manufactured radiopharmaceuticals to a vast range of nuclear medicine facilities in the Czech Republic and abroad.

The Division of Radiopharmaceuticals produces therapeutic and diagnostic medicinal substances for nuclear medicine (PET) in accordance to valid marketing authorizations.

PET - Positron emission tomography - is a medical imaging method based on the principle of the location of the generation of photons γ, which are created in the body by the annihilation of positrons released by the administered radioactive substance (radiopharmaceuticals) and electrons.

Certificates and licences:

  • License to manufacture medicinal and investigational medicinal products
  • License to distribute medicinal products
  • Certificate of good manufacturing practice for manufacturers of medicinal products
  • Certificate of good manufacturing practice for manufacturers of investigational medicinal products
  • SÚJB (State Office for Nuclear Safety) authorization for the use of ionizing radiation sources
  • ISO 9001:2008,
  • ISO 14001:2004,
  • BS OHSAS 18001:2007

Our products and services

  • For the needs of distribution, transport, and sale of medicinal products within the Czech Republic, we hold a certificate of good distribution practice as well as the necessary licences for ionising radiation management, and our monitored vehicles are subject to the rules of the ADR (European Agreement concerning the International Carriage of Dangerous Goods by Road - Accord Dangereuses Route)
  • Performing activities of Qualified Person (QP)
    • We have a sufficient number of experienced and qualified persons with high levels of expertise and education and who are able to ensure the release of the medicinal products for sale even via remote access

The defined and set chemical and physical control processes in the GMP mode cover areas of PET radiopharmaceuticals as well as other pharmaceutical raw substances and materials. Quality control with appropriate instrumentation includes

:

  • Input raw materials
  • Intermediate products
  • Medicinal products
  • Microbiological control
  • Monitoring stability
  • Validation of analytical methods

 

  • We are holders of all necessary permits and certificates
  • We have adequate spatial and technological facilities and experienced highly educated staff.

Address: ÚJV Řež, a. s., Hlavní 130, 250 68 Husinec - Řež

  • The PET Center serves primarily for the R&D of new radiopharmaceuticals with ultra-short-living PET radionuclides.
  • This project was awarded third place in the category of “Investor of 2010”.
    The prize for the highest innovation potential was awarded by CzechInvest in cooperation with the Ministry of Industry and Trade and the Association for Foreign Investment. The project was co-financed from the European Regional Development Fund (ERDF) and from the national budget of the Czech Republic under the POTENTIAL programme. The construction of a third floor of the R&D PET Centre Řež followed which, in cooperation with the health facility, plays a development-manufacturing-application role. The implementation of the second phase of the PET centre was supported by the European Regional Development Fund (ERDF) and the national budget of the Czech Republic under the OPPI programme (Operational Programme Enterprise and Innovation – Ministry of Industry and Trade), the Training Centre programme

 

Address:Nemocnice Na Homolce, Roentgenova 2,  č.p. 37, 150 30 Praha 5

  • This is the first PET centre in the Czech Republic and was built in cooperation with the International Atomic Energy Agency (IAEA). IAEA approved the plan as a model project and pledged financial support. Through this cooperation, the construction of the first PET centre in the Czech Republic on the premises of the Na Homolce Hospital in Prague was commenced in November 1998. The PET Centre Prague was inaugurated in August 1999, and it was here that the first patient in the Czech Republic was examined using the PET method.
  • The facility is equipped to manufacture the most commonly used PET radiopharmaceutical “Fludeoxyglukosa inj.” (commercial name of the product of ÚJV Řež, a. s.). This is a radiodiagnostics agent used by PET or PET/CT methods.

Address: Masarykův onkologický ústav, Žlutý kopec 7a, 656 53 Brno

  • In order to make the Moravian regions independent of supplies of PET radiopharmaceuticals from Central Bohemia, a second PET centre was built within the Masaryk Memorial Cancer Institute in Brno in 2005. The construction started in April 2006. This construction was partially funded as part of the INOVACE II programme of the European Regional Development Fund (ERDF) as well as from the national budget of the Czech Republic. The PET Centre Brno commenced trial operation on 1 June 2007.
  • The facility is equipped to manufacture the most commonly used PET radiopharmaceutical “Fludeoxyglukosa inj.” (commercial name of the product of ÚJV Řež, a. s.). This is a radiodiagnostics agent used by PET or PET/CT methods.

Contact

Division of Radiopharmaceuticals

    • Address:  ÚJV Řež, a. s., Hlavní 130, Řež, 250 68 Husinec, Czech Republic
    • Phone: +420 266 172 178
    • Fax: +420 220 940 945
    • E-mail: radiopharm@ujv.cz
We are the dominant player in the radiopharmaceutical market in the Czech Republic. Besides the production of fludeoxyglucose for PET examination and the operation of three PET centers, we are also dedicated to research and development of new medicinal products.