Institute of Isotopes Co. Ltd.

Founded in 1959, the Institute of Isotopes of the Hungarian Academy of Sciences began to produce radioactive isotopes in 1964. It became a major Hungarian centre for the research, development and production of radioisotopes. With effect from 1993 a part of the former Institute has been operating as the
Institute of Isotopes Co. Ltd.

IZOTOP is the major Hungarian centre for the research, development and production of radioisotopes and other products for a broad range of application areas, especially healthcare, research and industry.  Hundreds of products manufactured in our facilities and distributed worldwide.

Company operates in accordance with ISO 9001 and ISO 14001 QA system. We have GMP Certificate for pharmaceutical preparation and ISO 13485 standard for design, production and distribution of radioactive immunoassay kits.

1. RADIOPHARMACEUTICALS:

• Thyrotop I-131 sodium iodide hard capsules
• I-131 sodium iodide sterile solution
• I-131 MIBG injection for therapy and for diagnostic use
• Radiochemicals /I-125, I-131/
• Cold kits for Tc-99m-labelling: DMSA, DTPA, PYRON, FYTON, MDP, TECHIDA, EC
• Sm-153 -labelling MULTIBONE kit 

Ready to take part in R&D and manufacturing of active pharmaceutical ingredients, cold kits as well as investigational products for clinical trials.

2. IMMUNOASSAY: In Vitro Products for Human Diagnosis and Life Science

Kits for diagnostic (thyroid, tumour markers, protein hormones, diabetes etc.) and research purposes (RIA/IRMA and ELISA):

• Thyroid Function
• Steroid Hormones
• Protein Hormones
• Diabetes
• Tumor Markers

Research Immunoassay Kits

• Rat Hormones
• I-125 Labelled Compounds

IZOTOP’s Immunoassay business line is dedicated to develop, manufacture and supply high quality and cost effective products for clinical and research laboratory use.

We produce broad range  of immunoassay kits in RIA and IRMA formats covering assays in endocrinology, oncology and other fields of diagnostics. Our technology uses streptavidin coated surfaces (tubes and microplates) providing a simple, user-friendly separation method. The broad range of our products can be categorized according to the separation methods used, such as magnetic immunosorbent (MIS), coated tube (CT) and non-solid phase assays.
Immunoassay Business Line has certified quality management system according to ISO 13485 (certificate) standard for design, production and distribution of radioactive immunoassay kits.
Our in vitro diagnostic products are CE registered.

3. SYNTHESIS:

• Organic compounds labelled with C-14 or H-3 radioisotopes and C-13 stable isotope
• Custom synthesis
• Service for GMP snytheses of C-14 labelled APIs or Drug Substances
• Radiochemical repurification service

4. RADIATION TECHNIQUE:

• Ir-192, Co-60 industrial sources
• Gamma irradiators (laboratory and industrial)
• Hot cells
• Radiation hardness assurance test

In addition, the production of in vivo products also follows the principles of GMP as licensed by the Directorate General of National Institute of Pharmacy and Nutrition according to EU regulations.
All of IZOTOP’s products are subject to stringent safety measures and controls. Environmental protection against radioactive contamination is ensured by a multi-level safety system.