# PET tracer manufacturing and distribution

Source: https://onco.cc/technologies/pet-tracer-manufacturing/  
OnCo record `pet-tracer-manufacturing` (Technology). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Technology
- Status: standard-of-care
- Last checked: 2026-09-08
- Tags: supporting
- 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

## Sources

- 21 CFR Part 212: current good manufacturing practice for PET drugs: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-212

## Connected records

- fronts: [Imaging](https://onco.cc/fronts/imaging/), [Radiopharmaceuticals & Theranostics](https://onco.cc/fronts/radiopharma/)
- technologies: [CT, MRI and PET scanner manufacturing](https://onco.cc/technologies/medical-imaging-scanner-manufacturing/), [Cyclotron isotope production (F-18, Ga-68, Cu-64, Zr-89, At-211)](https://onco.cc/technologies/cyclotron-isotope-production/), [FES PET (oestrogen receptor imaging)](https://onco.cc/technologies/fes-pet/), [Medical cyclotrons, hot cells, and synthesis modules](https://onco.cc/technologies/medical-cyclotrons-synthesis-modules/), [PET (positron emission tomography)](https://onco.cc/technologies/pet/), [PSMA PET](https://onco.cc/technologies/psma-pet/), [Radionuclide generators and cold kits](https://onco.cc/technologies/radionuclide-generators-kits/), [Radiopharmaceutical GMP and releasing a drug that decays](https://onco.cc/technologies/radiopharmaceutical-gmp-release/), [Radiopharmacy and cyclotron networks](https://onco.cc/technologies/radiopharmacy-network/)
- companies: [Cardinal Health Nuclear & Precision Health Solutions](https://onco.cc/companies/cardinal-health/), [Isotopia Molecular Imaging](https://onco.cc/companies/isotopia/), [Jubilant Radiopharma](https://onco.cc/companies/jubilant-radiopharma/), [Lantheus](https://onco.cc/companies/lantheus/), [PETNET Solutions (Siemens Healthineers)](https://onco.cc/companies/petnet-solutions/), [SOFIE Biosciences](https://onco.cc/companies/sofie-biosciences/), [Telix Pharmaceuticals](https://onco.cc/companies/telix/)

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