radium ra-223 dichloride: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bayer Hlthcare	XOFIGO	radium ra-223 dichloride	SOLUTION;INTRAVENOUS	203971	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-208-01	6 mL in 1 VIAL, SINGLE-DOSE (50419-208-01)	2013-05-20
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 26, 2026

Radium Ra 223 dichloride (Xofigo, 223RaCl2) is supplied through a tightly controlled, radioactive-material supply chain. In practice, procurement is dominated by the original product manufacturer and its licensed radiopharmacy distribution partners, with availability dependent on country-specific regulatory authorizations for cyclotronless radiopharmaceutical handling and radioactive transport.

Who supplies radium Ra-223 dichloride (Xofigo) globally?

Primary commercial supplier (originator product):

Bayer supplies Xofigo (radium Ra 223 dichloride) under branded product distribution models via Bayer affiliates and approved distributors.

Where “suppliers” typically show up in procurement:

Licensed radiopharmacy/distributor partners (authorized to handle and distribute alpha-emitting radiopharmaceuticals).
Hospital/contract radiopharmacy sites that prepare/dispense per the local prescribing and administration workflow.
Authorized importers and logistics providers that move alpha emitters under radioactive-material transport rules.

What is the supply chain shape for Ra-223?

Ra-223 is an alpha-emitting radiopharmaceutical, so “supplier” usually means one of the following:

Product marketer / branded pack supplier (originator): Bayer.
Distribution partner: local authorized distributor/importer/radiopharmacy network.
Facility dispensing node: nuclear medicine pharmacy/hospital pharmacy that receives and administers.

What companies are licensed distributors of Xofigo (Ra-223) in the US and EU?

A complete, current “who supplies where” list depends on jurisdiction-specific authorization and can change with local distributor agreements. Under typical market practice, Xofigo supply in mature markets is handled through Bayer’s country affiliates plus appointed distributors and authorized radiopharmacies capable of storage, quality control, and dose preparation for alpha therapies.

United States supply model

Xofigo is marketed and distributed in the US by Bayer.
Dispensing is typically through authorized nuclear medicine and radiopharmacy channels that can receive and manage alpha-emitting radiopharmaceuticals.

European supply model

Xofigo is marketed in Europe by Bayer with country-level distribution through affiliates and approved distributors.
Administration occurs at sites with the licensing to handle Ra-223 and comply with radioactive waste and transport rules.

Do biosimilars or generics supply Ra-223 dichloride, or is it Bayer-only?

For Ra-223 dichloride, commercial supply is tied to the originator product because:

The product is a radiopharmaceutical with manufacturing and activity release tied to controlled radionuclide production and strict regulatory batch release.
Competition is constrained by the difficulty of producing and qualifying Ra-223 dichloride at scale under GMP and radiopharmaceutical distribution requirements.

As a result, generic substitution is not a typical procurement pathway for Ra-223 dichloride in the way it is for conventional small-molecule drugs.

Which contract manufacturing and radionuclide production capabilities matter for Ra-223?

For radiopharmaceuticals, the “supplier” ecosystem is split between:

Radionuclide production (the upstream Ra-223 isotope supply chain).
Drug substance/drug product manufacturing (formulation into 223RaCl2 and GMP batch release).
Radiopharmacy distribution and administration logistics.

In the Ra-223 case, product availability is governed primarily by the originator’s control of radionuclide sourcing, manufacturing, and regulatory release, with downstream distribution executed by licensed partners.

How do hospitals typically procure Ra-223 dichloride supplies?

Procurement flows through:

Direct purchase channels with the originator/distributor approved for that country.
Radiopharmacy receipt and handling under local nuclear medicine and radiation safety licensing.
Dose scheduling because Ra-223 dosing is time-sensitive based on activity and decay management.

Key practical procurement points:

Allocation and scheduling: supply planning is often required to meet administration windows.
Site capability: the receiving facility must be authorized to accept alpha emitters and manage radioactive waste.

What regulatory status affects supplier availability of Ra-223?

Ra-223 dichloride supply depends on:

FDA approval and distribution controls for the approved product in the US.
EMA and national authority authorization in Europe.
Transport and handling licenses for alpha-emitting radiopharmaceuticals.
Nuclear medicine facility permissions for receipt, storage, and administration.

Those controls generally funnel supply through originator-linked channels rather than open market sourcing.

How to evaluate supplier risk for Ra-223 dichloride (allocation, logistics, and continuity)

When qualifying a “supplier” or vendor for radiopharmaceutical availability, buyers typically score on:

Country-specific authorized distributor coverage (ability to legally import and distribute).
Cold chain and radiological logistics capability for alpha emitters.
Batch release and supply lead time (activity-based scheduling).
Service continuity for scheduled oncology treatment timelines.

Key Takeaways

Bayer is the dominant commercial supplier of radium Ra 223 dichloride (Xofigo) through country affiliates and approved distribution partners.
Procurement typically happens through authorized radiopharmacies and licensed distributors, not through open generic substitution.
Supplier choice is constrained by radiopharmaceutical manufacturing control, activity release, and alpha-emitter transport and handling regulations.
For any jurisdiction, the “supplier list” is operationally defined by Bayer’s authorized distribution network and licensed receiving sites.

FAQs

Can hospitals buy radium Ra-223 dichloride from alternative distributors not affiliated with Bayer?
Supply depends on country authorization; in practice, procurement routes are typically through Bayer’s approved distributor/importer network and authorized radiopharmacy nodes.
Is radium Ra-223 dichloride available as a generic or biosimilar product?
Generic substitution is not a typical procurement model for Ra-223; commercial supply is tied to originator control and regulated radiopharmaceutical manufacturing and release.
What qualifications must a pharmacy have to receive Ra-223 dichloride shipments?
The receiving facility must be licensed to handle and store alpha-emitting radiopharmaceuticals, comply with radioactive material transport rules, and perform appropriate quality and dose management workflows.
How does radioactive decay impact Ra-223 supply planning and administration?
Decay drives scheduling and dose timing. Procurement and receiving must align with administration windows to ensure delivered activity is within prespecified limits.
What typically causes delays in Ra-223 availability?
The most common drivers are batch release timing, radionuclide supply constraints upstream, transport and receipt capacity at licensed sites, and allocation planning tied to treatment schedules.

References (APA)

European Medicines Agency. (n.d.). Xofigo (radium Ra 223 dichloride) product information and assessment materials. EMA.
U.S. Food and Drug Administration. (n.d.). Xofigo (radium Ra 223 dichloride) prescribing information and regulatory documents. FDA.
Bayer. (n.d.). Xofigo (radium Ra 223 dichloride) product and distribution information. Bayer.

Suppliers and packagers for generic pharmaceutical drug: radium ra-223 dichloride