Share This Page
Suppliers and packagers for axumin
✉ Email this page to a colleague
axumin
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for axumin
AXUMIN (fluciclovine F 18) suppliers: who manufactures, supplies, and where bulk/import flows sit in the supply chain
Executive summary: AXUMIN is a positron emission tomography (PET) radiopharmaceutical supplied in the US by Blue Earth Diagnostics, a Cardinal Health affiliate, via a centralized US radiopharmacy/production network. The active ingredient is fluciclovine F 18, produced through radiochemical synthesis of the corresponding precursor(s), then formulated for injection and distributed under strict radiation and time-temperature controls. In practice, customers access AXUMIN through authorized nuclear medicine distributors and radiopharmacies that dispense it to imaging sites.
Note: A complete, supplier-by-supplier map (manufacturing site, NDA sponsor role, authorized distributor list, and specific contract partners) requires confirmable public listings for AXUMIN’s current US distribution model, including FDA label “How Supplied” language and current US package insert details. With the information provided, a fully accurate supplier ledger cannot be produced.
Who supplies AXUMIN in the US (Blue Earth Diagnostics vs distributors)?
Answer (what is reliably used operationally): AXUMIN’s US supply is tied to the NDA holder’s radiopharmacy distribution model. In the US market, deliveries to imaging providers are typically executed through authorized nuclear medicine supply chains rather than generic commercial wholesalers.
Key supply-chain roles
- NDA/sponsor entity: Responsible for labeling, quality system oversight, and controlled manufacturing/release.
- Radiopharmacy network/distribution points: Dispense AXUMIN to end-user imaging sites under radiation logistics constraints.
- Authorized distributors / logistics partners: Handle time-critical transport and compliance with radiation safety requirements.
What to look for in public product labeling (to confirm the exact parties)
- “How Supplied” section listing package configurations and distribution channel language
- Sponsor/manufacturer address
- Labeling statement naming the company responsible for supply/distribution
Which companies manufacture fluciclovine F 18 for AXUMIN?
Answer: AXUMIN is manufactured as a radiopharmaceutical using a fluciclovine F 18 synthesis route. The manufacturing entity is the NDA holder or its contracted radiochemical manufacturing partners under GMP and radiation compliance.
Manufacturing model in practice
- Central production of fluciclovine F 18 (time-critical radio synthesis)
- Formulation for injection
- Batch release testing and chain-of-custody logistics
- Distribution to qualified dispensing sites
Why a supplier list is sensitive
- Radiopharmaceutical suppliers often change based on site qualifications and validated process transfers.
- “Manufacturer” on FDA labeling can differ from “distributor” on procurement systems.
What is the FDA label-specified manufacturer and distributor for AXUMIN?
Answer: The FDA label identifies the company responsible for distribution and supplies the packaged radiopharmaceutical for injection. For AXUMIN, the manufacturer/distributor information is typically embedded in the package insert “How Supplied” and label sections.
Operational impact
- Hospitals and imaging centers procure based on the label distribution model.
- Procurement compliance depends on correct labeling for the supplier and contact points.
How does AXUMIN get distributed to PET imaging sites (radiopharmacy vs wholesaler)?
Answer: AXUMIN is distributed through nuclear medicine channels designed for short-lived PET isotopes, usually via radiopharmacies and authorized nuclear medicine distributors, not via standard retail pharma wholesaling.
Distribution constraints
- Short half-life logistics (F-18)
- Radiation safety requirements
- Temperature and handling constraints
- Same-day delivery and validated receiving procedures
Does AXUMIN use centralized manufacturing or site-level radiopharmacies?
Answer: The typical PET radiopharmaceutical operating model is centralized synthesis with subsequent dispensing by authorized radiopharmacies. End-user imaging sites often do not perform radiochemistry synthesis themselves.
What determines the exact model
- NDA manufacturing section and distribution description
- Authorized dispensing arrangements
- Qualified facility licensing for radiopharmaceutical handling
What are the key sourcing risks for AXUMIN (capacity, isotope supply, logistics)?
Answer: The largest practical supply risks for AXUMIN are:
- Production capacity constraints at the centralized radiochemistry sites
- Time-critical logistics affecting delivery windows
- Isotope availability and upstream supply for F-18 production
- Regulatory/quality deviations that halt batch release
Who are the downstream suppliers for hospitals: acquisition and contracting patterns
Answer: Hospitals acquire AXUMIN through authorized contracting channels, typically:
- Contracted nuclear medicine supply distributors
- Local/region radiopharmacies authorized to dispense the product
- Integrated health-system pharmacy procurement units that manage radiopharmaceutical receiving
Procurement artifacts that identify the supplier
- Contracting dashboards (GPO/VMS)
- Radiology service procurement agreements
- Purchase orders referencing the labeled distributor/manufacturer
How many AXUMIN suppliers exist and do they differ by region?
Answer: In PET radiopharmaceutical markets, supplier counts often reflect:
- One labeled distribution/sponsor entity
- Multiple authorized dispensing points by geography
What changes regionally
- Which radiopharmacies receive and dispense it locally
- Transit time windows by site and receiving hours
How does AXUMIN supplier coverage compare with other F-18 PET agents (e.g., fludeoxyglucose F 18)?
Answer: Like FDG and other F-18 PET tracers, AXUMIN typically uses time-critical radiopharmaceutical distribution networks. Comparison points that matter operationally:
- Central synthesis vs local compounding
- Dispensing radiopharmacies authorized by the NDA holder’s distribution model
- Delivery windows aligned to PET scheduling needs
Key Takeaways
- AXUMIN is supplied via a controlled PET radiopharmaceutical distribution network under the NDA holder’s manufacturing and release model.
- End-user dispensing is performed through authorized radiopharmacies/distribution channels rather than standard pharma wholesale routes.
- A precise supplier-by-supplier list (names of specific distributors/radiopharmacies/manufacturing sites) cannot be stated accurately without AXUMIN label “How Supplied” and current FDA labeling/manufacturer sections.
FAQs
- Who is the NDA holder responsible for AXUMIN supply in the US?
- Do hospitals dispense AXUMIN themselves, or does a radiopharmacy supplier dispense it?
- What logistics constraints drive AXUMIN delivery and supplier performance?
- How can imaging centers verify the correct AXUMIN manufacturer/distributor on receiving documentation?
- What upstream factors can disrupt AXUMIN availability for PET sites?
References (APA)
- FDA. (n.d.). AXUMIN prescribing information/labeling (Drug approval package resources). U.S. Food and Drug Administration.
More… ↓
