Isotopia Molecular Imaging files Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for Lu n.c.a.
PETACH TIKVA, Israel, Aug. 18, 2020 /PRNewswire/ -- Isotopia Molecular Imaging is pleased to announce that it has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for no-carrier-added Lutetium-177 (n.c.a. Lu(177)), a medical radioisotope.
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n.c.a. Lu(177), a radiopharmaceutical precursor, is used in Targeted Radionuclide Therapy in the field of Precision Oncology. Radiolabeled to disease-specific targeting molecules, the tumor tissue is precisely destroyed. Isotopia has developed a GMP unique stable consistent and reliable method to produce a highly pure form of Lu(177). n.c.a Lu(177) contains no metastable Lu-177m, therefore there is no need for cost intensive clinical waste management.
Isotopia's CEO, Dr. Eli Shalom stated "this is another achievement for Isotopia on its way to become a global leader in medical isotope's production and supply. We have come a long way from a centralized nuclear pharmacy to a global GMP isotope manufacturer. Our mission in the near future is to install state-of-the-art production facility in the US and EU Territories. These sites will be mass production for Pharma companies. Beyond that, the next breakthrough into the global market is due to purchased FDA approved and EU certified aseptic pharmaceutical plant for theragnostic cold kits."
The DMF filling is a necessary and significant step towards making a substantial contribution to meeting the growing demand of Targeted Radionuclide Therapies within the U.S and Canadian markets. This will allow Isotopia to supply n.c.a. Lu(177) to pharmaceutical companies developing new and innovative radiopharmaceuticals and take part in their clinical and commercial supply.
Isotopia will now focus on upscaling production in the Israeli site and establishing another site to support the global supply and demand making sure that patients get treated anywhere and at any time.
About Isotopia
Isotopia Molecular Imaging Ltd. is a collaboration between The Metrontario Group and Israel's leading scientists in the field of radiopharmaceuticals. The Isotopia development team is a multidisciplinary team consisting of nuclear pharmacists, radiochemists, nuclear engineers and physicists.
The experienced Isotopia team, together with its radio-nuclear pharmacy, cyclotron facility, Lu(177) production site and sterile manufacturing, are a well-established platform for development. Isotopia creates collaborations between the scientific and medical community to further develop and experiment with new markers for imaging applications and molecular therapy. www.isotopia.co.il
Contact:
Isotopia Molecular Imaging Ltd.
Business Development
Keren Moshkoviz
Tel: (972) -3-9130314
KMoshkoviz@isotopia.co.il
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SOURCE Isotopia Molecular Imaging
