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Suppliers and packagers for FLUORODOPA F18
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FLUORODOPA F18
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Feinstein | FLUORODOPA F18 | fluorodopa f-18 | SOLUTION;INTRAVENOUS | 200655 | NDA | THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH | 13267-345-56 | 25 mL in 1 VIAL, GLASS (13267-345-56) | 2019-10-10 |
| Feinstein | FLUORODOPA F18 | fluorodopa f-18 | SOLUTION;INTRAVENOUS | 200655 | NDA | THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH | 13267-346-57 | 30 mL in 1 VIAL, GLASS (13267-346-57) | 2019-10-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for FLUORODOPA F18
FLUORODOPA F18 suppliers: who sells F-18 fluorodopa (18F-DOPA) and what are the sourcing constraints
Executive summary: FLUORODOPA F18 (18F-fluorodopa; 18F-DOPA) is supplied to hospitals and PET centers through a small set of global radiopharmaceutical manufacturers and their national distribution networks. In practice, sourcing is constrained by regional radiopharmacy licenses, the availability of on-site cyclotrons or validated generator supply chains, and cold-chain handoff rules. The supplier landscape is typically stable but varies by country due to regulatory status and radiopharmacy licensing.
No complete, accurate supplier list is possible from the information provided. A correct “suppliers for FLUORODOPA F18” answer requires validated current product availability by geography and regulatory listing (eg, FDA/Orange Book-equivalent where applicable, EU national competent authority listings, and local Authorized Distributor status). The prompt contains no country/region scope and no source dataset to verify specific supplier entities, product presentations, lead times, or distribution status.
Which companies supply FLUORODOPA F18 in the US and EU?
Answer: A verified supplier list depends on the target geography and current regulatory authorizations for 18F-fluorodopa radiopharmaceutical supply and distribution. Without a defined region and current regulatory listing, any named company list risks being inaccurate.
US-specific supplier mapping (what must be confirmed)
- Radiopharmaceutical manufacturing authorization for 18F-fluorodopa
- Distribution authorization for radiopharmaceutical intermediates or finished dosage forms
- Current availability and labeling for the specific commercial presentation (multi-dose vs. unit-dose, activity ranges)
- PET center receiving requirements (temperature, radiation shipping, chain-of-custody documentation)
EU-specific supplier mapping (what must be confirmed)
- National authorization in each member state
- Authorized manufacturer and authorized distributor chain
- Batch release testing location and site qualification for the receiving radiopharmacy
Are FLUORODOPA F18 suppliers the same as PET isotopes suppliers (F-18 generators/cyclotron sites)?
Answer: Not always. FLUORODOPA F18 is a radiopharmaceutical (18F-fluorinated amino acid) produced through a validated synthesis using F-18, a precursor, and a GMP process. Many “F-18 isotope” supply arrangements do not automatically translate into “FLUORODOPA F18 finished product” supply capability.
Typical supply-chain split
- F-18 production (cyclotron service) or F-18 supply channel
- GMP radiochemistry production of 18F-fluorodopa
- Finished dose vial distribution to hospitals/radiopharmacies
- Local administration within the validated timeframe
What delivery model do FLUORODOPA F18 suppliers use (direct to hospital vs contract radiopharmacy)?
Answer: FLUORODOPA F18 is commonly delivered either:
- Directly to licensed nuclear medicine sites under radiopharmaceutical distribution agreements, or
- Through contract radiopharmacies that then supply final administration doses to patient sites.
The correct model is country-specific and depends on who holds the local distribution and receiving authorizations.
What are the biggest constraints for sourcing FLUORODOPA F18?
Answer: The constraints are operational, regulatory, and logistics-driven:
- Half-life and same-day production requirement (operational scheduling)
- GMP radiochemistry capacity and batch scheduling
- Radiation-shipping and receiving constraints at the hospital/radiopharmacy
- Radiopharmacy licensing and QA release requirements
- Precursor procurement and validated synthesis conditions
- Peak-demand periods (availability variability)
How does supplier availability vary by country and PET center network size?
Answer: Supply density is higher in regions with:
- Multiple cyclotron or centralized GMP radiochemistry sites
- Dense PET center networks with frequent demand
- Established procurement agreements that support consistent weekly ordering
In lower-density regions, radiopharmaceutical supply often relies on longer logistics windows, fewer authorized distributors, and tighter batch planning.
What documentation do radiopharmacies require from FLUORODOPA F18 suppliers?
Answer: Receiving sites typically need:
- Certificate of Analysis or equivalent release documentation
- Batch record summaries relevant to QC tests
- Activity concentration, volume, and radionuclidic purity statements
- Shelf-life and time-based usability window
- Transport conditions and chain-of-custody records
Can a PET center source FLUORODOPA F18 in-house instead of buying from a supplier?
Answer: In-house production is possible where the PET center has:
- A validated cyclotron and radiochemistry capability for 18F-fluorodopa synthesis
- GMP-like manufacturing and QA release procedures aligned to local regulations
- Qualified staff, equipment, and controlled quality system
This is usually cost-effective only for high-volume centers or systems with integrated radiochemistry infrastructure.
How do procurement lead times and shipping windows affect FLUORODOPA F18 ordering?
Answer: Ordering is typically constrained to:
- Same-day or near-term production slots
- Time-critical dispatch windows due to F-18 decay
- Receiving appointment timing for dose preparation and patient scheduling
What generic or alternative products compete with FLUORODOPA F18 and change supplier choices?
Answer: Competitive substitutes are generally not “generic” in the conventional small-molecule sense because radiopharmaceuticals are produced under time-bound, process-validated conditions. Practical competition often comes from:
- Alternative PET tracers with different indications or protocols
- Different supply routes (manufacturer vs contract radiopharmacy)
- Alternative dosing strategies within the approved prescribing framework
Key Takeaways
- FLUORODOPA F18 sourcing depends on regional regulatory authorization and radiopharmacy licensing, not only on F-18 isotope access.
- Supplier availability varies by country due to GMP production capacity, distribution authorizations, and same-day logistics constraints.
- A precise supplier list requires geography-specific, regulator-backed product availability and distributor authorization data; the prompt does not include those inputs.
FAQs
- What is the typical shelf-life window for FLUORODOPA F18 on receipt by a PET center?
- Does FLUORODOPA F18 require cold-chain storage beyond radiation-shipping constraints?
- Can hospitals qualify an external contract radiopharmacy to supply FLUORODOPA F18 doses?
- How do radiopharmacies handle batch failure or delayed release for FLUORODOPA F18?
- What precursor supply issues most often affect FLUORODOPA F18 production availability?
References
- No sources were provided in the prompt.
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