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Suppliers and packagers for generic pharmaceutical drug: RADIUM RA-223 DICHLORIDE
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RADIUM RA-223 DICHLORIDE
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: RADIUM RA-223 DICHLORIDE
Introduction
Radium-223 dichloride (Xofigo, marketed by Bayer) is a targeted alpha therapy primarily used for metastatic castration-resistant prostate cancer (mCRPC) with bone metastases. Its unique mechanism involves delivering alpha radiation directly to bone metastases, leading to cytotoxic effects while minimizing systemic toxicity. Given its specialized medical application, the supply chain involves a select group of manufacturers and distributors, with production heavily regulated due to the radioactive nature of the compound.
Manufacturers and Licensing of Radium-223 Dichloride
Currently, Bayer AG holds the exclusive rights to produce and distribute Radium-223 dichloride (Xofigo) globally. The drug was developed after significant research and clinical validation, with Bayer acquiring rights through licensing agreements and investments in manufacturing facilities compliant with stringent regulatory standards.
Key facts:
- Origin: Bayer's global manufacturing facilities are certified by authorities such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other regulatory bodies.
- Production Capacity: Bayer has established specialized facilities capable of producing radioactive isotopes, including Radium-223 dichloride, adhering to Good Manufacturing Practices (GMP).
Since the original patent and exclusivity rights predominantly belong to Bayer, third-party manufacturing options are limited. However, alternative sources for raw materials, especially radium isotopes, exist globally.
Sources for Raw Material Radium Isotopes
Radium-223 is produced via nuclear reactors or particle accelerators. Its supply chain centers on the procurement of radium-226 or radium-223 isotopes, which are then processed into the pharmaceutical form.
Major suppliers of radium isotopes include:
- SAF Ra-226 – South African facilities producing radium-226 as a byproduct of uranium mining operations. These suppliers provide high-purity radium compounds used in research and limited medical applications.
- Anton Paar GmbH – Offers radionuclide standards, including radium isotopes, which could be utilized in manufacturing or research settings.
- Nuclear research reactors – Such as the BR2 reactor in Belgium or the OSIRIS reactor in France, which produce radium isotopes through neutron irradiation, supplying medical and research institutions worldwide.
Note: The production of Radium-223 for pharmaceutical applications is tightly controlled and not typically available for third-party licensing in unregulated settings. Instead, Radium-223 dichloride is supplied directly under strict licenses to authorized healthcare providers.
Distributors and Chain of Supply
Post-manufacture, distribution channels involve:
- Authorized Distributors: Bayer supplies Xofigo through a global network of authorized pharmaceutical distributors and specialty pharmacies.
- Regional Distributors: In the U.S., companies such as Alliance Healthcare, McKesson, and Cardinal Health distribute Xofigo to medical facilities under strict regulatory oversight.
Regulatory oversight requires that all distribution adheres to radiation safety standards, with secure packaging, proper storage, and handling protocols, especially given the radioactive characteristics.
Emerging Suppliers and Market Dynamics
Given the limited competition and Bayer’s patent exclusivity (which expires in certain jurisdictions, e.g., the U.S. in 2027), opportunities for new suppliers are constrained. However, future market entries hinge on:
- Development of biosimilar or alternative alpha-emitting radiopharmaceuticals.
- Expansion of raw material production—especially if new production technologies for radium isotopes emerge.
- Regulatory approvals for generic products or alternative manufacturing pathways.
It is important to monitor industry developments, particularly advancements in targeted alpha therapies, which might introduce substitutes or complementary products in the same therapeutic niche.
Regulatory and Safety Considerations
The procurement, manufacturing, and distribution of Radium-223 dichloride involve compliance with numerous regulatory frameworks:
- U.S. FDA: Requires licenses under the Nuclear Regulatory Commission (NRC).
- European Medicines Agency (EMA): Ensures GMP compliance.
- International Atomic Energy Agency (IAEA) Guidances: For radioactive material handling.
This regulatory environment limits the number of qualified suppliers and necessitates stringent quality assurance practices across the supply chain.
Key Takeaways
- Bayer AG maintains exclusive rights to produce and distribute Radium-223 dichloride globally.
- Raw materials, primarily radium isotopes, are supplied by specialized nuclear facilities, with production tightly controlled due to their radioactive nature.
- Distribution is handled through authorized channels, with stringent adherence to safety and regulatory standards.
- Future supply expansion depends on technological advancements, regulatory changes, and market demand for alternative targeted alpha therapies.
- The regulatory environment constrains the emergence of new suppliers in the short term; market entry is predominantly via licensing agreements or biosimilar development post patent expiry.
FAQs
Q1. Are there any generic or alternative suppliers for Radium-223 dichloride?
Currently, no generics are approved or marketed for Radium-223 dichloride, given patent exclusivity and regulatory restrictions. Any future generics depend on patent expiry and regulatory approval pathways.
Q2. How is Radium-223 produced for pharmaceutical use?
Radium-223 is produced by irradiating radium-226 in nuclear reactors, refining the isotope, and then formulating it into a pharmaceutical product under strict GMP conditions.
Q3. What are the primary risks associated with sourcing Radium-223?
Risks include regulatory hurdles, limited number of qualified producers, safety concerns related to handling radioactive materials, and geopolitical factors affecting nuclear material supply chains.
Q4. Can third-party companies supply Radium-223 for research purposes?
Yes, but only under licenses from nuclear regulatory authorities, with usage limited to research or clinical trial applications rather than commercial therapeutic distribution.
Q5. What are the future prospects for supply and competition in Radium-223 markets?
The market is primarily controlled by Bayer. Future competition may arise from biosimilar development once patents expire, or from novel alpha-emitting radiopharmaceuticals if they receive regulatory approval.
Sources
- Bayer AG official product documentation: Xofigo (Radium-223 dichloride).
- U.S. Food and Drug Administration (FDA). Drug Approvals and Regulatory Information.
- International Atomic Energy Agency (IAEA). Guidelines on handling radioactive pharmaceuticals.
- Nuclear Regulatory Commission (NRC). Licensing requirements for radioactive material production and distribution.
- Industry reports on radiopharmaceuticals and nuclear isotope supply chain analysis.
This comprehensive overview offers business professionals critical insights into the supply landscape of Radium-223 dichloride, emphasizing regulatory nuances, supplier dynamics, and market future considerations.
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