Rafarma Pharmaceuticals is pleased to announce that it has signed a preliminary agreement to establish a production center for medical isotopes and radiopharmaceuticals in Almaty, Kazakhstan. An agreement on joint pharmaceutical production was signed with the Republican State Enterprise on the right of economic management “Institute of Nuclear Physics” of the Ministry of Energy of the Republic of Kazakhstan (INP) in Almaty on October 3, 2023.
The conclusion of an agreement between partners sets the goal of creating a production center for the synthesis of active pharmaceutical substances based on medical isotopes, and radiopharmaceutical drugs, investing in this project, and promoting the project on international markets, including its presentation at reputable exhibitions and conferences.
The created center will be on the balance sheet of Rafarma Pharmaceuticals and will not be a joint venture or joint investment project.
The main tasks being implemented within the framework of the center project in Almaty:
Purification of customer-supplied raw materials, namely strontium-82 and actinium-225, to pharmaceutical quality at the Institute of Nuclear Physics of the Ministry of Energy of the Republic of Kazakhstan with subsequent supply to foreign markets;
Construction and equipping and/or retrofitting of a site for the purification of customer-supplied raw materials and the production of APIs on the basis of the Institute of Nuclear Physics of the Ministry of Energy of the Republic of Kazakhstan for the purpose of its subsequent certification by the FDA;
Registration of radiopharmaceuticals based on PSMA (GMP class, chemical precursors for radiopharmaceuticals), namely an enantiomeric pure labeling precursor for PSMA labeled 68Ga, 177Lu, 225Ac. Also, conducting pre-clinical and clinical studies at the expense of Rafarma pharmaceuticals;
Organization of a production site for irradiation and packaging of microspheres based on 90Y for the ASEAN markets.