Suppliers and packagers for generic pharmaceutical drug: rubidium chloride rb-82

rubidium chloride rb-82

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bracco	CARDIOGEN-82	rubidium chloride rb-82	INJECTABLE;INJECTION	019414	NDA	Bracco Diagnostics Inc	0270-0091-01	1 INJECTION, SOLUTION in 1 PACKAGE (0270-0091-01)	1989-12-30
Jubilant	RUBY-FILL	rubidium chloride rb-82	SOLUTION;INTRAVENOUS	202153	NDA	Jubilant DraxImage Inc., dba Jubilant Radiopharma	65174-021-10	1 INJECTION, SOLUTION in 1 CONTAINER (65174-021-10)	2016-09-30

Suppliers for the Pharmaceutical Drug: Rubidium Chloride (Rb-82)

Last updated: August 1, 2025

Introduction

Rubidium chloride (Rb-82), a radiopharmaceutical isotope, is primarily utilized in nuclear medicine for myocardial perfusion imaging. Its application in positron emission tomography (PET) scans enables detailed visualization of blood flow in cardiac tissues. Due to its short half-life (~1.3 minutes) and high demand for on-site production, sourcing Rb-82 involves specialized suppliers, primarily based in regions with established radiopharmaceutical manufacturing infrastructure. This article delineates the landscape of suppliers providing rubidium chloride (Rb-82), highlighting key players, sourcing channels, regulatory considerations, and market dynamics.

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Overview of Rb-82 as a Pharmaceutical Agent

Rubidium-82 is generated via a strontium-82/rubidium-82 generator system, which enables clinical use in hospitals and imaging centers. The generator typically contains strontium-82, which decays to produce Rb-82. This setup allows for on-demand radiotracer production without requiring a cyclotron on site. The high efficacy and rapid imaging protocols of Rb-82 PET make it indispensable in cardiology, elevating the importance of reliable supplier networks.

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Primary Suppliers of Rb-82

1. Bracco Imaging S.p.A.

• Overview: An established leader in radiopharmaceuticals, Bracco offers the Cardiogen-82 brand, a generator system providing Rb-82 for clinical use.
• Products: CardioGen-82 Generator.
• Market Presence: Globally distributed, with extensive regulatory approvals.
• Key Features: Optimized for clinical workflow efficiency, with a focus on quality assurance and regulatory compliance.

2. GE Healthcare

• Overview: Currently, GE Healthcare ceased manufacturing the Rb-82 generator in some regions; however, it historically supplied radiopharmaceutical generators, including Rb-82 solutions through licensing agreements.
• Market Status: Buyers often rely on secondhand or existing stock, emphasizing the importance of alternative suppliers.
• Notes: Due to market exits, GE’s role is now more limited, prompting clinicians to seek other sources.

3. Jubilant Radiopharma

• Overview: A rising player in radiopharmaceuticals, Jubilant Radiopharma offers various PET tracers and generator systems.
• Products: Provides Rb-82 generators designed with regulatory standards for North American markets.
• Market Niche: Focuses on Novartis partnerships for strontium/rubidium generators.

4. IsoRay Medical

• Overview: Specializes in radiopharmaceuticals and implements generator systems for Rb-82.
• Highlights: Focuses on regulatory compliance and supply reliability within North America.

5. Other Notable Regional Suppliers

• In Europe and Asia, regional firms may supply Rb-82 generators or pre-processed solutions, often under licensing agreements from major global producers. Some notable names include Eczacibasi Monrol (Turkey) and NTP Radioisotopes (South Africa).

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Sourcing Channels and Considerations

Generator-Based Supply Model:

Since Rb-82 has a 1.3-minute half-life, direct transportation over long distances is unfeasible. Thus, hospitals and imaging centers typically procure strontium-82/rubidium-82 generators for on-site use. The static inventory within these generators requires regular replacement, usually every 4–6 weeks, depending on usage rates.

Regulatory Compliance:

Suppliers must adhere to strict Good Manufacturing Practices (GMP) and obtain necessary approvals (e.g., FDA, EMA, PMDA, TGA). Certification ensures safety, efficacy, and traceability, critical for clinical acceptance.

Global Supply Constraints and Market Dynamics:

The market has experienced fluctuations due to regulatory hurdles, manufacturing capacity constraints, and geopolitical factors. For instance, the discontinuation of certain generators by major providers has impacted supply consistency, prompting hospitals to establish strategic partnerships or stockpile generators.

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Regulatory and Market Challenges

• Short Shelf Life: The rapid decay of Rb-82 necessitates frequent generator replacement and high local production capacity.
• Limited Number of Suppliers: Few manufacturers globally possess the proprietary technology and regulatory clearances to produce Rb-82 generators.
• Regulatory Hurdles: Approval processes vary by country, complicating international procurement.

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Emerging Trends and Future Outlook

• Development of Alternative Radiotracers: Advances in PET imaging may diversify or supplement Rb-82’s role in cardiac diagnostics.
• Innovations in Generator Technology: Newer generator designs aim to improve shelf life and output efficiency.
• Regional Manufacturing Expansion: Countries are investing in domestic isotope production, reducing dependence on imports and buffer shortages.

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Key Takeaways

• The primary suppliers of Rb-82 peptides are Bracco Imaging and Jubilant Radiopharma, with regional manufacturers supplementing supply.
• The unique half-life of Rb-82 necessitates localized generator-based supply, constraining global distribution.
• Regulatory compliance, generator reliability, and production capacity are critical considerations for procurement decisions.
• The market faces ongoing challenges due to limited suppliers and logistical complexities, prompting innovation and regional manufacturing initiatives.
• Strategic planning, including inventory management and supplier diversification, is vital for healthcare providers relying on Rb-82 for cardiac PET imaging.

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FAQs

1. Who are the main global suppliers of Rb-82 generators?
Bracco Imaging and Jubilant Radiopharma are the primary global suppliers, offering commercially available generators approved for clinical use in multiple countries.

2. Can Rb-82 be shipped over long distances like other pharmaceuticals?
No. Due to its short half-life (~1.3 minutes), Rb-82 cannot be shipped over long distances. Generators must be located within proximity to clinical facilities for effective use.

3. What regulatory approvals are necessary for Rb-82 generators?
Manufacturers and suppliers must secure approvals such as FDA clearance (U.S.), EMA certification (Europe), or equivalent licenses in their respective jurisdictions, ensuring safety and efficacy.

4. Are there regional differences in Rb-82 supply?
Yes. Regional manufacturers cater to local markets, and availability depends on regional regulatory status and infrastructure capacity. For example, in Europe, Eczacibasi Monrol supplies generators, while North America relies mainly on Jubilant Radiopharma.

5. What factors influence the choice of Rb-82 supplier for a healthcare facility?
Factors include regulatory approval status, generator reliability, supply consistency, cost, regional availability, and after-sales support.

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References

1. [1] Bracco Imaging. CardioGen-82 Generator. Available at: [BraccoOfficial Website].
2. [2] Jubilant Radiopharma. Rubidium-82 Generators. Available at: [JubilantRadiopharmasite].
3. [3] European Medicines Agency. Regulatory Guidelines on Radiopharmaceuticals.
4. [4] U.S. Food and Drug Administration. FDA Approval Status of Rb-82 Generators.
5. [5] Market Research Reports on Radiopharmaceuticals Supply Chain.

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Conclusion

The supply chain for rubidium chloride (Rb-82) hinges on specialized generator technology, with a limited but strategically significant roster of global providers. As the demand for high-quality cardiac imaging grows, so too does the importance of sourcing reliable, compliant, and efficient Rb-82 generators. Healthcare providers should prioritize supplier reliability, regulatory compliance, and logistical planning to ensure uninterrupted access to this vital radiopharmaceutical.