Suppliers and packagers for XOFIGO

XOFIGO

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

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

Suppliers and packagers for XOFIGO

Last updated: June 1, 2026

XOFIGO (radium Ra 223 dichloride) suppliers: who manufactures and supplies the drug substance and finished product?

Executive summary: XOFIGO is supplied to the market as radium Ra 223 dichloride injection. Bayer holds the commercial role in most markets and supplies XOFIGO via its distribution network. GMP manufacture of the radioactive active substance and finished dosage form is typically performed through specialized nuclear medicine supply chains that manage radionuclide procurement, radiochemical processing, quality control, and sterile fill-finish. Publicly verifiable supplier-level granularity for the drug substance is limited due to radionuclide sourcing and confidentiality around radiochemical manufacturing.

Who are the manufacturers and suppliers of XOFIGO (radium Ra 223 dichloride) in the US and EU?

Short answer (commercial supply): Bayer is the known marketing authorization holder and distributor for XOFIGO in major jurisdictions, including the US and EU (per regulatory labeling and product websites).

US supply: what entity supplies XOFIGO to FDA-regulated channels?

XOFIGO is marketed in the US under NDA/BLA oversight by the marketing authorization holder listed in the FDA label. The product is obtained through Bayer’s distribution network into oncology and hospital pharmacy channels that handle radiopharmaceutical dispensing under applicable radiation safety rules.

EU supply: who supplies XOFIGO to hospitals under the EMA marketing authorization?

In the EU, XOFIGO is supplied through the marketing authorization holder and hospital distribution channels aligned to EMA labeling and national radiopharmacy regulations.

What companies supply radium for XOFIGO’s radioactive drug substance chain?

Short answer: XOFIGO depends on radionuclide supply for Ra-223 production, which is typically sourced from radionuclide production systems operated by specialized nuclear material producers and processed through radiochemical facilities.

What does the XOFIGO radionuclide supply chain include?

1. Radionuclide procurement for Ra-223 production or supply of Ra-223-containing material.
2. Radiochemical processing to convert to radium Ra 223 dichloride drug substance specifications.
3. GMP release testing for identity, purity, radiochemical purity, specific activity, and radionuclidic purity.
4. Sterile formulation and vial filling under radiopharmaceutical manufacturing controls.
5. Cold-chain and radiation-handling logistics for distribution to licensed radiopharmacies and administering sites.

Which CDMO/contract manufacturers make XOFIGO drug product (formulation, sterile fill-finish) for Bayer?

Short answer: XOFIGO’s finished dose is a sterile injection produced under radiopharmaceutical GMP. The identity of the exact contract manufacturing site(s) at a CDMO granularity is not consistently disclosed in a supplier-list format in public sources. Public label documents identify the MAH and manufacturing sites but do not always name non-Bayer contract partners in a way that maps cleanly to “supplier” categories.

How to interpret “supplier” for XOFIGO

• Marketing authorization holder/distributor: who sells and distributes XOFIGO.
• Manufacturer of drug product: who performs sterile manufacturing and fill-finish.
• Manufacturer of drug substance: who performs radiochemical conversion to the active pharmaceutical ingredient.
• Radionuclide producer: who supplies the radionuclide feedstock or Ra-223 derived material.

What are the Orange Book listings or FDA manufacturing listings that identify XOFIGO manufacturing and release sites?

Short answer: XOFIGO is not a typical oral generic-style product with Orange Book patent listings used for generic substitution analysis. For supplier identification, the relevant public artifacts are FDA labeling (Highlights/Section 16) and NDC-associated labeling/manufacturing information that can list manufacturing and/or packager sites.

What label sections usually include manufacturing site data

• “Manufactured for” or “Distributed by”
• “Manufactured by” / “Packaged by”
• Site addresses tied to GMP release

How are XOFIGO suppliers constrained by radioactive materials handling and GMP?

Short answer: XOFIGO supply is constrained more by radionuclide availability and radiopharmaceutical GMP capacity than by routine sterile manufacturing scale.

Key bottlenecks that affect supplier capacity

• Limited ability to source or generate Ra-223 feedstock at scale
• Radiochemical processing capacity with validated GMP controls
• Radiation safety licensing and transport constraints
• Release testing throughput for radiochemical assays
• Regional radiopharmacy receiving and dispensing capability

What generic or biosimilar-style “supplier” models exist for XOFIGO, and do they change supplier concentration?

Short answer: XOFIGO is a radiopharmaceutical with a complex radionuclide supply chain. Even if competing products or follow-on radiopharmaceuticals emerge, they still require radionuclide access and radiochemical/sterile GMP manufacturing.

Why standard generics do not map cleanly to XOFIGO

• Radionuclide sourcing and radiochemical purity specs drive supply capability.
• Approval paths for radiopharmaceuticals typically require rigorous characterization of identity, purity, specific activity, and performance.

How many supplier tiers exist for XOFIGO and who owns each tier?

Short answer: XOFIGO supply typically spans multiple tiers:

• Tier 1: Bayer as MAH/distributor (commercial supply and distribution)
• Tier 2: Radiopharmaceutical manufacturer (sterile injectable drug product manufacture)
• Tier 3: Radiochemical/drug substance manufacturer (Ra-223 dichloride specification attainment)
• Tier 4: Radionuclide producer/handler (Ra-223 feedstock supply)

What supply risks exist for XOFIGO based on supplier concentration and radionuclide availability?

Short answer: Supply risk is driven by scarcity and production cycles of Ra-223 and by limited radiochemical GMP manufacturing capacity.

Risk categories that affect hospital sourcing

• Manufacturing downtime at a radiopharmaceutical site
• Delays in radionuclide procurement or processing campaigns
• Transport restrictions for radioactive materials
• Quality hold/release delays for radiochemical specs

Key Takeaways

• XOFIGO is supplied commercially through Bayer as the market-facing entity in major jurisdictions.
• The radioactive nature of Ra-223 means supplier concentration is shaped by radionuclide availability and radiochemical GMP capacity, not standard contract sterile manufacturing alone.
• Publicly verifiable “supplier” detail at the radiochemical drug-substance and radionuclide producer level is often not fully enumerated in a simple list, but the supply chain tiers are consistent: MAH/distributor, drug product manufacturer, drug substance manufacturer, and radionuclide supplier.

FAQs

1. Who distributes XOFIGO to hospitals and oncology clinics in the US?
2. Do XOFIGO manufacturing sites change by NDC or lot, and where is this shown on labeling?
3. What does the Ra-223 radionuclide supply chain require beyond sterile manufacturing?
4. Can suppliers of radiopharmaceuticals substitute for drug substance suppliers for XOFIGO?
5. What operational constraints most affect XOFIGO availability during periods of demand spikes?

References

1. Bayer. XOFIGO (radium Ra 223 dichloride) Prescribing Information and/or US FDA label.
2. FDA. XOFIGO label and product information (NDA label/manufacturing and distribution sections).
3. EMA. XOFIGO product information and EU marketing authorization documentation.