Suppliers and packagers for CHOLINE C-11

CHOLINE C-11

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mcprf	CHOLINE C-11	choline c-11	INJECTABLE;INTRAVENOUS	203155	NDA	Mayo Clinic	52670-556-30	30 mL in 1 VIAL (52670-556-30)	2012-09-12

Suppliers and packagers for CHOLINE C-11

Last updated: June 4, 2026

CHOLINE C-11 Suppliers: What companies sell C-11 choline for PET imaging and who manufactures it

Suppliers for CHOLINE C-11 (a radiopharmaceutical used in PET imaging) are concentrated in a small set of nuclear medicine radiopharmacy networks and radionuclide supply chains that can produce or procure C-11 and perform the final synthesis under local quality systems. Market availability is typically through regional radiopharmacies rather than “traditional” wholesalers, with product supply governed by cyclotron access, short half-life logistics, and regulatory authorization in each country.

Who are the CHOLINE C-11 suppliers and which companies manufacture or distribute it?

CHOLINE C-11 is commonly supplied as an off-the-shelf radiopharmaceutical via:

• Cyclotron-to-radiopharmacy operators that run radiosynthesis locally (company-owned or contracted).
• Radiopharmacy networks that either (a) produce C-11 choline at member sites or (b) receive it from a production site capable of same-day delivery.
• Specialty nuclear medicine distributors that distribute radiopharmaceuticals under chain-of-custody controls and comply with national radiological and pharmaceutical regulations.

Named supplier identification requires country- and NDC/authorization-specific sourcing. Without a specific target jurisdiction (US, EU, UK, etc.) and the exact marketed presentation (kit vs. ready-to-inject solution, batch size, labeling), a complete and accurate supplier list cannot be produced.

H3: Are there “kit” suppliers or only radiopharmacy production?

Most commercial supply of C-11 choline is handled as a prepared radiotracer by an authorized radiopharmacy. Kits are less common than for longer-lived PET agents because C-11 logistics are operationally tied to same-day production.

H3: Which capability determines supplier eligibility?

• C-11 production (cyclotron or reliable procurement of C-11 feedstock)
• Automated radiosynthesis for choline formulation
• Quality release testing for radiochemical purity, sterility, endotoxin (as required), and radionuclidic purity
• Authorized distribution in the destination market

What distributors supply CHOLINE C-11 in the US and what is the typical supply model?

In the US, PET radiotracers with short half-lives are typically supplied by:

• radiopharmacies registered and authorized for compounding/dispensing,
• often tied to hospital imaging centers or contracted nuclear medicine providers,
• with distribution constrained by same-day cold-chain and radiation shipping rules.

A complete supplier list for CHOLINE C-11 depends on whether the product is marketed as a finished radiopharmaceutical versus compounded under an appropriate authorization. Without the jurisdiction-specific FDA/registrant mapping and labeling status, a precise supplier roster cannot be generated.

What European suppliers provide CHOLINE C-11 and how do national authorization rules affect availability?

In the EU and UK, supplier availability is shaped by:

• national authorization for radiopharmaceutical manufacture/dispensing,
• Good Manufacturing Practice (GMP) or relevant local frameworks for radiopharmaceutical preparation,
• radiological transport authorization and same-day distribution realities.

Because supplier rosters are country-specific, accuracy requires mapping to:

• the specific member state of interest,
• the authorized manufacturer/distributor on the product labeling and import authorizations.

How do I identify legitimate CHOLINE C-11 suppliers by regulatory status and documentation?

For procurement and compliance, suppliers should be validated using:

• marketing authorization and labeling in the destination market (as applicable),
• radiopharmacy registration and scope of authorized activities,
• GMP compliance where required for manufacturing,
• certificate of analysis (CoA) process for each batch including radiochemical purity and sterility/relevant release parameters,
• documented chain-of-custody and radiation transport procedures.

Which suppliers can meet C-11 short half-life logistics for CHOLINE C-11?

C-11’s ~20-minute half-life makes feasible supply dependent on:

• proximity to a cyclotron capable of producing C-11
• validated same-day workflow (production release to delivery to imaging site)
• operational capacity for weekend/holiday scheduling where used in routine oncology workflows

A supplier can claim capability only if they provide a documented operational model: production window, typical delivery time, and release testing timeline.

CHOLINE C-11 sourcing vs. competitors: what procurement risks exist if you use the wrong supplier?

Key procurement risks for CHOLINE C-11 include:

• delivery failure due to production delays or cyclotron downtime
• dose variability from late delivery (practical impact on imaging dose calibration)
• quality release constraints if release testing is not aligned with time-to-injection needs
• regulatory mismatch if supplier authorization is not valid for the destination site

These risks are minimized by selecting suppliers with established C-11 PET operations at or near the imaging network.

Key Takeaways

• CHOLINE C-11 supply is dominated by authorized nuclear medicine radiopharmacies and PET radiotracer operators with same-day production or secured production-to-delivery chains.
• Supplier eligibility is driven by cyclotron access, radiosynthesis capability, quality release testing, and same-day logistics.
• A complete, accurate supplier list requires destination-market mapping to authorized manufacturers/distributors and the specific marketed presentation.

FAQs

1. What distance limits matter for CHOLINE C-11 delivery?
   Delivery is typically constrained to same-day, short travel windows consistent with C-11 half-life, with practical limits determined by site-to-cyclotron distance and release-to-dose timing.

2. Can hospital imaging centers produce CHOLINE C-11 themselves?
   Only if they have an appropriate cyclotron capability and authorized radiopharmacy/manufacturing permissions in their jurisdiction and meet release testing requirements.

3. How should buyers evaluate CoA quality for CHOLINE C-11?
   Buyers should require CoA parameters aligned with regulatory expectations for radiochemical purity, radionuclidic identity, sterility, and endotoxin (as applicable) and ensure test timing supports injection.

4. What happens if a CHOLINE C-11 shipment is late?
   Late arrival can force dose reduction, rescheduling, or study cancellation due to C-11 decay and injection timing constraints.

5. Do CHOLINE C-11 suppliers offer dose calibration services?
   Many radiopharmacy suppliers provide standard dose calibration labeling and delivery documentation, but the exact service depends on the contracted workflow.

References

1. (No external sources cited because no jurisdiction- or listing-specific supplier facts were provided in the prompt.)