{"entity":{"id":"pet-tracer-manufacturing","kind":"technology","name":"PET tracer manufacturing and distribution","aka":[],"tldr":"Making PSMA, FDG, and new tracers under drug-manufacturing rules and delivering them daily.","summary":"FDA-approved PET drugs are made under cGMP at commercial radiopharmacies (PETNET, Cardinal Health, SOFIE, Jubilant, Curium) or academic sites under ANDA/NDA. New tracers (PSMA agents from Lantheus, Telix, Novartis; FES; FAPI in trials) rely on these networks for launch reach. Kits (Illuccix, Locametz) versus centrally produced doses (Pylarify) is a business-model divide.","status":"standard-of-care","asOf":"2026-09-08","links":[{"label":"21 CFR Part 212: current good manufacturing practice for PET drugs","url":"https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-212"}],"tags":["supporting"],"related":[],"cancers":[],"sections":["imaging","radiopharma"],"technologies":["pet","psma-pet","radiopharmacy-network"],"targets":[],"drugs":[],"companies":["petnet-solutions","cardinal-health","sofie-biosciences","lantheus","telix","jubilant-radiopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":["medical-cyclotrons-synthesis-modules"],"notes":[],"principle":"Automated radiosynthesis modules, cassette-based chemistry, and rapid QC (radiochemical purity, endotoxin) before release.","strengths":["Daily national coverage in the US and Europe"],"limitations":["Tracer approval per site","Kit vs central-dose economics","Limited reach in low-income countries"]},"route":"/technologies/pet-tracer-manufacturing/","neighbours":{"section":[{"id":"imaging","kind":"section","name":"Imaging","route":"/fronts/imaging/"},{"id":"radiopharma","kind":"section","name":"Radiopharmaceuticals & Theranostics","route":"/fronts/radiopharma/"}],"technology":[{"id":"medical-imaging-scanner-manufacturing","kind":"technology","name":"CT, MRI and PET scanner manufacturing","route":"/technologies/medical-imaging-scanner-manufacturing/"},{"id":"cyclotron-isotope-production","kind":"technology","name":"Cyclotron isotope production (F-18, Ga-68, Cu-64, Zr-89, At-211)","route":"/technologies/cyclotron-isotope-production/"},{"id":"fes-pet","kind":"technology","name":"FES PET (oestrogen receptor imaging)","route":"/technologies/fes-pet/"},{"id":"medical-cyclotrons-synthesis-modules","kind":"technology","name":"Medical cyclotrons, hot cells, and synthesis modules","route":"/technologies/medical-cyclotrons-synthesis-modules/"},{"id":"pet","kind":"technology","name":"PET (positron emission tomography)","route":"/technologies/pet/"},{"id":"psma-pet","kind":"technology","name":"PSMA PET","route":"/technologies/psma-pet/"},{"id":"radionuclide-generators-kits","kind":"technology","name":"Radionuclide generators and cold kits","route":"/technologies/radionuclide-generators-kits/"},{"id":"radiopharmaceutical-gmp-release","kind":"technology","name":"Radiopharmaceutical GMP and releasing a drug that decays","route":"/technologies/radiopharmaceutical-gmp-release/"},{"id":"radiopharmacy-network","kind":"technology","name":"Radiopharmacy and cyclotron networks","route":"/technologies/radiopharmacy-network/"}],"company":[{"id":"cardinal-health","kind":"company","name":"Cardinal Health Nuclear & Precision Health Solutions","route":"/companies/cardinal-health/"},{"id":"isotopia","kind":"company","name":"Isotopia Molecular Imaging","route":"/companies/isotopia/"},{"id":"jubilant-radiopharma","kind":"company","name":"Jubilant Radiopharma","route":"/companies/jubilant-radiopharma/"},{"id":"lantheus","kind":"company","name":"Lantheus","route":"/companies/lantheus/"},{"id":"petnet-solutions","kind":"company","name":"PETNET Solutions (Siemens Healthineers)","route":"/companies/petnet-solutions/"},{"id":"sofie-biosciences","kind":"company","name":"SOFIE Biosciences","route":"/companies/sofie-biosciences/"},{"id":"telix","kind":"company","name":"Telix Pharmaceuticals","route":"/companies/telix/"}]}}