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 for the Pharmaceutical Drug: XOFIGO

Last updated: August 5, 2025

Introduction

XOFIGO (known generically as radium Ra 223 dichloride) is a targeted alpha therapy used primarily in the treatment of prostate cancer with bone metastases. Developed by Bayer Pharmaceuticals, XOFIGO has established itself as a significant treatment option in the oncology landscape. As with many innovative biologics and radiopharmaceuticals, the supply chain for XOFIGO comprises specialized suppliers that encompass raw material providers, manufacturing entities, fill-finish contractors, and distribution networks. For healthcare providers, pharmacies, and stakeholders, understanding the supplier ecosystem of XOFIGO is crucial for ensuring drug availability, managing procurement strategies, and maintaining regulatory compliance.

This article explores the key suppliers involved across the XOFIGO supply chain, highlighting their roles, market positioning, and relevance within the pharmaceutical ecosystem.

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Manufacturers of Active Pharmaceutical Ingredients (API)

The foundation of XOFIGO's supply chain hinges on the procurement of radium Ra 223 dichloride, a radioactive isotope that delivers targeted alpha radiation to bone metastases. Radium-223 dichloride is a complex radiopharmaceutical produced through specialized nuclear chemistry processes, usually within licensed radiopharmaceutical manufacturing facilities.

Currently, Bayer is the sole provider of commercial-grade radium Ra 223 dichloride used in XOFIGO formulations. The company's integrated manufacturing facilities in a controlled environment produce the API, ensuring radiochemical purity, safety, and regulatory compliance. Bayer's control over the API production process makes it the primary supplier for XOFIGO, granting the company exclusive rights due to the high technical complexity and regulatory barriers associated with radiopharmaceuticals.

Key Supplier:

• Bayer Pharmaceuticals: As the sole manufacturer and supplier of radium Ra 223 dichloride for XOFIGO, Bayer holds a dominant position in the API supply chain. The company manufactures the radiopharmaceutical under strict Good Manufacturing Practice (GMP) standards, correlating to its role as the sole radiological API supplier globally.

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Manufacturing and Fill-Finish Partners

Once the active pharmaceutical ingredient is produced, it undergoes further processing, including formulation, filling, labeling, and packaging, to produce the final XOFIGO drug product.

Bayer contracts specialized contract manufacturing organizations (CMOs) for the fill-finish process. These CMOs are responsible for aseptically filling the radiopharmaceutical into pre-sterilized vials, sealing, quality control, and preparing the drug for distribution. The high-level of radiation safety and compliance requirements restrict the number of capable manufacturing sites.

Although specific associate CMOs are often undisclosed due to confidentiality, known reputable companies in radiopharmaceutical fill-finish services include:

• STEREOTAXIS (Germantown, Maryland): Known for handling sensitive radiopharmaceuticals, including targeted alpha therapies.
• Eczacıbaşı Sterilization & Packaging: An international contractor specializing in sterile filling and packaging of complex biologics and radiopharmaceuticals.
• Recipharm: A global contract manufacturer with expertise in sterile injectables, potentially involved in radiopharmaceutical production.

Bayer maintains strict oversight and quality control standards to ensure consistency and regulatory compliance of the final product.

Distribution and Logistics

Radiopharmaceuticals like XOFIGO demand sophisticated logistics due to their short half-life (about 11.4 days) and radioactive nature. This necessitates a reliable network of specialized distribution partners with expertise in handling radioactive materials, ensuring secure, timely delivery to hospitals and clinics.

Bayer coordinates a global logistics network, often collaborating with specialized courier companies such as:

• DHL Global Forwarding: With experience in medical and radioactive shipments.
• FedEx Medical Express: Providing temperature-controlled, secure shipments for radiopharmaceuticals.
• Local nuclear pharmacies and regional distribution centers: Ensuring rapid transit to end-users.

The geographic distribution network is strategically optimized to deliver XOFIGO within its effective shelf life, often within hours of manufacture, emphasizing the importance of tight integration within the supply chain.

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Regulatory and Compliance Suppliers

Ensuring the safety and efficacy of XOFIGO hinges on compliance with regulatory authorities, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global agencies. These regulatory bodies provide stringent standards that suppliers must adhere to concerning quality control, radiation safety, storage, and transportation.

Suppliers involved in all stages must maintain GMP certification, and radioactive materials are subject to licensing and oversight by nuclear regulatory authorities such as the Nuclear Regulatory Commission (NRC) in the U.S. or the respective agencies in Europe and other regions.

Bayer’s internal regulatory department, along with third-party auditors and certifiers, ensure ongoing compliance and oversee supplier qualification.

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Future Supply Chain Considerations

The unique nature of radiopharmaceuticals limits the number of capable suppliers, concentrating supply risk among a small set of manufacturers and logistics providers. These constraints underscore the importance of alternative sourcing strategies, including:

• Expanding production capacity for radium Ra 223 dichloride.
• Developing alternative suppliers with established regulatory approval.
• Innovating in radiopharmaceutical technology to diversify supply sources.

In addition, increasing demand for targeted alpha therapies may incentivize other players to enter the supply chain, potentially reducing reliance on Bayer.

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Key Takeaways

• Bayer dominates the API supply for XOFIGO, holding exclusive rights as the sole commercial producer of radium Ra 223 dichloride.
• Specialized contract manufacturers handle fill-finish, packing, and labeling, operating under strict GMP and radiation safety standards.
• Logistics networks for XOFIGO require high-level expertise due to its radioactive nature and short half-life, with global courier services playing pivotal roles.
• Regulatory oversight is integral at every stage, with compliance ensuring safety and efficacy.
• Supply chain resilience depends on capacity expansion, alternative sourcing, and innovation within radiopharmaceutical manufacturing.

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Conclusion

The supply chain for XOFIGO exemplifies the complex, highly specialized landscape of radiopharmaceutical manufacturing and distribution. Bayer's exclusive control over radium Ra 223 dichloride underscores the importance of strategic partnerships, regulatory compliance, and logistical sophistication. As demand for targeted alpha therapies grows, diversification of supply sources and technological advancements will be crucial to ensuring consistent access to this critical prostate cancer therapy.

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FAQs

1. Who is the primary supplier of radium Ra 223 dichloride for XOFIGO?
   Bayer Pharmaceuticals is the sole producer of radium Ra 223 dichloride used in XOFIGO, thanks to their proprietary manufacturing process and regulatory approval.

2. Are there any alternative suppliers for XOFIGO's active ingredient?
   Currently, no alternative suppliers exist commercially, given the technical complexities and regulatory barriers. Bayer maintains exclusivity in producing radium Ra 223 dichloride.

3. What are the challenges in supplying XOFIGO globally?
   Short half-life, radiation safety concerns, and stringent regulatory requirements limit scalability and create logistical challenges, necessitating specialized distribution networks.

4. How does regulatory oversight impact XOFIGO’s supply chain?
   It enforces strict manufacturing standards, licensing, and quality controls, restricting production capacity and supplier eligibility to those with appropriate approvals.

5. Are there prospects for new suppliers entering the radiopharmaceutical space?
   Yes, rising demand and technological advances may incentivize new entrants, although their entry involves overcoming significant scientific, regulatory, and safety hurdles.

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References

[1] Bayer. "Xofigo (Radium Ra 223 Dichloride) Prescribing Information." 2022.
[2] European Medicines Agency. "Xofigo: product information." 2022.
[3] World Nuclear Association. "Radiopharmaceuticals and Nuclear Medicine." 2022.
[4] U.S. Food and Drug Administration. "Radiation Safety and Medical Use." 2022.
[5] Market research reports on radiopharmaceutical manufacturing and supply chain logistics, 2022.