Suppliers and packagers for generic pharmaceutical drug: FLUCICLOVINE F-18

FLUCICLOVINE F-18

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054	NDA	Blue Earth Diagnostics	69932-001-30	30 mL in 1 VIAL, MULTI-DOSE (69932-001-30)	2016-05-27
Blue Earth	AXUMIN	fluciclovine f-18	SOLUTION;INTRAVENOUS	208054	NDA	Blue Earth Diagnostics	69932-001-50	50 mL in 1 VIAL, MULTI-DOSE (69932-001-50)	2016-05-27

Fluciclovine F-18 Suppliers: What Companies Provide Production, Raw Materials, and Imaging Service Delivery

Last updated: May 26, 2026

Fluciclovine F-18 (18F fluciclovine) is supplied through a tight ecosystem centered on (1) US FDA-authorized radiopharm manufacturers producing the isotope-labeled drug substance and (2) distributor/medical imaging channel partners that supply site-ready doses to nuclear medicine practices. The supplier base is constrained by radiochemistry capability, GMP release, and radionuclide logistics.

Because “suppliers” can mean different links in the value chain (drug product manufacturer, radiopharmacy contractor, logistic distributor, or starting material provider), the highest-confidence supplier set is the manufacturers that produce or distribute FDA-released Fluciclovine F-18 doses in the US market through the authorized radiopharmacy network.

Who supplies Fluciclovine F-18 doses in the US market?

Primary supply chain structure

1. 18F cyclotron production and isotope supply: produced at facilities with fluorine-18 capabilities and licensed radiochemistry operations.
2. 18F fluciclovine production (GMP drug substance/drug product): executed by radiopharmaceutical manufacturers under FDA oversight.
3. Distribution to radiopharm sites: shipped as cold-chain, short half-life products to nuclear medicine and PET centers with validated handling.
4. Administration services: provided by imaging centers; they may not be product “suppliers” but are the end-customer receiving doses.

US product market anchor (brand)

• Fluciclovine F 18 is marketed as Axumin.

What is the FDA-approved manufacturer/supplier profile for Axumin (fluciclovine F-18)?

FDA labeling-driven supplier mapping For radiopharmaceuticals, the most reliable “supplier” identification is the company listed on the FDA-approved product labeling and FDA registration/distribution listing, which tie manufacturing and distribution to a specific authorized entity.

Axumin is sourced from the FDA-listed radiopharmaceutical manufacturing/distribution operation(s) and then fulfilled through radiopharmacy logistics for delivery to clinical sites.

Which companies are typically in the Fluciclovine F-18 supply chain

The practical supplier categories you should expect for fluciclovine F-18 include:

• Radiopharmaceutical manufacturers with fluorine-18 capability and FDA GMP release.
• Authorized radiopharmacy distributors / logistic providers operating within short half-life radiopharma cold-chain requirements.
• Hospital and imaging-network radiopharm providers that receive, dispense, and administer site doses.

In most US radiopharma markets, the “supplier” list you see in contracting and purchasing is a combination of:

• the FDA-registered radiopharmaceutical manufacturer of Axumin, and
• regional distribution/fulfillment partners that cover geographies based on cyclotron and shipping lanes.

What raw materials suppliers are needed to make fluciclovine F-18?

Key inputs in fluorine-18 labeled radiopharmaceutical production

Fluciclovine F-18 production depends on:

• Fluorine-18 produced radionuclide (18F-F source produced from cyclotron irradiation of an appropriate target).
• Non-radioactive precursor chemistry to generate fluciclovine under radiochemical synthesis conditions.
• GMP-grade reagents, solvents, and sterile formulation components, including:
  • sterile diluents and buffers,
  • filtration and aseptic processing consumables,
  • quality control reagents for identity, purity, and radionuclidic checks.

Are starting material suppliers contract-disclosed?

For radiopharmaceuticals, upstream chemical supplier contracts are often not fully enumerated publicly in consumer-facing supplier lists; the publicly visible “supplier” most buyers can contract with is the finished-dose manufacturer/distributor rather than the upstream reagent supplier.

What distributors or radiopharmacy networks supply Fluciclovine F-18 to nuclear medicine centers?

Distribution is typically via radiopharmacy networks Because fluciclovine F-18 has a short physical half-life, distribution is usually optimized through:

• regional radiopharmacy depots,
• same-day or next-day shipping,
• validated cold-chain handling and dose tracking.

Supplier-facing reality for procurement Clinical procurement for Fluciclovine F-18 commonly routes through:

• the radiopharmaceutical distributor named in ordering systems and contracts, and
• the radiopharmacy fulfillment entity that coordinates lot release, QC release documentation, and delivery timing.

How do suppliers for fluciclovine F-18 compare with suppliers for other PET tracers?

Fluciclovine F-18 sits in the same operational category as other fluorine-18 PET tracers (F-18 FDG class) in terms of:

• requirement for fluorine-18 isotope supply,
• GMP radiochemistry constraints,
• short half-life logistics,
• limited vendor pool.

Competitive differences

• Tracers that are produced in higher volumes with more standardized chemistry often have wider supplier participation.
• Axumin-type supply chains usually show fewer public-facing alternatives due to specialized synthesis steps and regulatory manufacturing scope.

What supplier risk issues matter for Fluciclovine F-18 availability?

Supply continuity variables

For buyers, supplier risk is driven by:

• cyclotron outages at isotope production sites,
• radiochemistry batch failures,
• sterility/sterile filtration process deviations,
• QC release delays,
• cold-chain disruptions,
• limited capacity relative to demand surges.

Procurement and allocation

Where supply is constrained, vendors and distributor networks allocate based on:

• validated site handling capability,
• ordering history,
• geography and shipping windows,
• allocation rules tied to distribution performance.

What are the key supplier procurement pathways for healthcare systems?

Common pathways

1. Direct purchase from an Axumin distributor/fulfillment partner with radiopharmacy dispensing at the receiving site.
2. Purchasing through a GPO/contracting framework where radiopharma items are pre-negotiated by network.
3. Radiology-imaging network procurement where a centralized radiopharmacy purchases and distributes to affiliated clinics.

Which suppliers matter most for licensing, reimbursement, and contracting?

For contracting

The supplier that matters most is the entity that:

• holds responsibility for GMP release of FDA-labeled Axumin,
• can provide COAs, lot release documentation, and timely distribution.

For reimbursement and substitution

Reimbursement and interchangeability are tied to product identity and NDC/labeling, not upstream raw material vendors. Substitution decisions usually track to FDA-approved product and supply continuity.

Key takeaways

• “Suppliers” for fluciclovine F-18 in practice resolve to the FDA-approved Axumin manufacturing/distribution entities and the authorized distributor/radiopharmacy network that delivers short half-life doses to nuclear medicine sites.
• Procurement is constrained by fluorine-18 isotope availability, GMP radiochemistry capacity, QC release timelines, and logistics.
• For high-stakes decisions (allocation planning, continuity, contracting), the decision-grade supplier is the finished-dose manufacturer/distributor listed on FDA labeling and ordering systems used by clinical sites.

FAQs

1) Who can healthcare systems purchase Axumin (fluciclovine F-18) from?
Axumin is purchased via authorized distributor and radiopharmacy fulfillment channels that deliver FDA-labeled doses to clinical sites.

2) Are there multiple manufacturers for fluciclovine F-18 in the US?
Fluciclovine F-18 supply is limited to qualified radiopharmaceutical manufacturers with FDA-authorized manufacturing and distribution capability; the effective supplier count is typically narrow versus high-volume PET tracers.

3) What happens to fluciclovine F-18 supply during cyclotron downtime?
Demand shifts to the next available production and distribution routes, often producing allocation at site level based on shipping windows and QC release timing.

4) Can radiopharmacies source fluciclovine F-18 from starting material chemical suppliers?
Commercial dispensing for clinical dosing is typically sourced as a finished, FDA-labeled product through authorized channels; upstream chemical sourcing is not the common procurement model for clinics.

5) What is the biggest operational constraint for fluciclovine F-18 suppliers?
The short half-life drives shipping schedules, lot release timing, and regional distribution coverage, making capacity and logistics the dominant constraints.

References

1. U.S. Food and Drug Administration. Axumin (fluciclovine F 18) prescribing information and product labeling. FDA label database.
2. U.S. Food and Drug Administration. Drug Shortages database (for radiopharmaceutical availability and disruption signals, if applicable).