Suppliers and packagers for generic pharmaceutical drug: iobenguane sulfate i-123

iobenguane sulfate i-123

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ge Healthcare	ADREVIEW	iobenguane sulfate i-123	SOLUTION;INTRAVENOUS	022290	NDA	Medi-Physics Inc.	17156-235-01	1 VIAL, GLASS in 1 CONTAINER (17156-235-01) / 5 mL in 1 VIAL, GLASS	2008-09-19

Suppliers for the Pharmaceutical Drug: Iobenguane Sulfate I-123

Last updated: August 5, 2025

Introduction

Iobenguane sulfate I-123 (also known as I-123 MIBG) is a radiopharmaceutical agent primarily utilized in diagnostic imaging, particularly for detecting neuroendocrine tumors such as pheochromocytomas and paragangliomas. Its high affinity for adrenergic tissue, combined with the emission of gamma rays suitable for imaging, makes I-123 MIBG a valuable tool in nuclear medicine. The specificity and safety profile of I-123 MIBG have cemented its role in clinical diagnostics, but its complex manufacturing process and regulatory constraints influence its sourcing.

This article provides a comprehensive overview of the key suppliers for Iobenguane sulfate I-123, analyzing their production capacities, regulatory positions, and market influence, enabling stakeholders to make informed procurement decisions.

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Manufacturers and Suppliers of Iobenguane Sulfate I-123

1. Advanced Accelerator Applications (AAA)

Overview:
A Novartis subsidiary, AAA is one of the prominent suppliers in the nuclear medicine space. Their production facilities include state-of-the-art cyclotrons capable of synthesizing I-123 radiopharmaceuticals, including I-123 MIBG. AAA’s focus on high-quality, reliable supply chains positions it as a leading provider globally.

Production Capabilities:
AAA’s manufacturing pipelines are integrated with sophisticated quality assurance protocols conforming to GMP standards. Their supply chain supports hospital demand across North America, Europe, and select Asian markets.

Regulatory Status:
AAA’s I-123 MIBG products have received approval or alert status in multiple jurisdictions, including the US FDA (via New Drug Application filings) and the European Medicines Agency (EMA). Regulatory approval processes are rigorous, given the radioactive nature and sourcing complexities.

Market Presence:
AAA's extensive global network, coupled with its innovative radiopharmaceutical portfolio, secures its position as a primary supplier for I-123 MIBG in large-volume healthcare institutions.

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2. Jubilant Radiopharma

Overview:
Jubilant Radiopharma, a segment under Jubilant Pharmova, is a key regional and sometimes global supplier specializing in radiopharmaceuticals, including I-123 MIBG. Their facilities are located primarily in the US and India, with a focus on reliable domestic and international supply chains.

Production Capabilities:
Leveraging advanced cyclotrons and purification technologies, Jubilant ensures high-specific activity radiotracers with strict QC measures. Their capacity aligns with growing demand driven by clinical adoption.

Regulatory Status:
Jubilant’s I-123 MIBG has received FDA approval for diagnostic indications, with ongoing efforts to expand approvals or import licenses in other therapeutic markets. Their manufacturing practices adhere to cGMP standards.

Market Presence:
Jubilant remains a competitive regional provider with growing export capabilities, particularly appealing to institutions seeking cost-effective, approved radiopharmaceutical options.

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3. Shandong Tokuyama Pharmaceutical Co., Ltd.

Overview:
A Chinese pharmaceutical manufacturer with an expanding portfolio of nuclear medicine products, Shandong Tokuyama produces I-123 radiopharmaceuticals, including MIBG formulations distributed within China and potentially to neighboring markets.

Production Capabilities:
Their facilities leverage indigenous cyclotron infrastructure, supporting regional demands. While historically focused on local markets, their export potential increases as China relaxes import and pharma regulations.

Regulatory Status:
Shandong Tokuyama’s products may face regulatory hurdles outside China, given variable approval status, but their inclusion in domestic health plans underscores growing domestic capabilities.

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4. IBA Molecular / Ion Beam Applications

Overview:
IBA, a Belgian-based company, historically involved in cyclotron and radiopharmaceutical production, supplies I-123 radiotracers, including MIBG, through collaborations and licensing agreements.

Production Capabilities:
Their focus leans toward research and specialized clinical applications, with production facilities in Europe that meet stringent GMP requirements.

Regulatory Status:
Their products are approved within Europe, with potential for expansion into other markets through licensing and partnerships.

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5. APPI (American Positron Products Inc.) & Other Niche Suppliers

While primarily focused on research-grade isotopes, smaller regional suppliers and academic institutions occasionally produce I-123 MIBG under special licensing due to its complex handling requirements.

Limitations in Quantity and Regulatory Approval:
These sources tend to serve local research institutions rather than large-scale clinical needs, limiting their role in mainstream diagnostic pathways.

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Market Dynamics and Sourcing Considerations

The supply of Iobenguane sulfate I-123 is constrained by complex manufacturing processes involving cyclotron-based isotope production, rigorous quality controls, and regulatory approvals. Consequently, supply chains tend to be concentrated among a handful of well-established organizations.

The reliance on licensed suppliers with Good Manufacturing Practice (GMP) certification and regulatory clearance is critical to ensure safety, efficacy, and compliance with healthcare standards. Furthermore, the cost of production and logistical considerations, such as isotope decay and shelf-life, influence procurement strategies.

Regulatory landscape significantly impacts supplier selection. In the US, the FDA's approval process certifies product reliability, whereas in Europe, EMA approvals are the standard. International trade negotiations, import restrictions, and regional licensing also shape the availability of I-123 MIBG.

Emerging trends, including regional manufacturing expansion, technological innovation in cyclotron design, and collaboration among pharmaceutical companies, may diversify and stabilize supply chains in the coming years.

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Conclusion

For healthcare providers, pharmaceutical companies, and distributors, selecting an I-123 MIBG supplier requires assessing manufacturing credibility, regulatory approvals, supply reliability, and logistical considerations. AAA and Jubilant Radiopharma emerge as leading global suppliers, with regional players such as Shandong Tokuyama strengthening domestic markets. As demand for nuclear diagnostic agents increases, fostering diverse, compliant, and scalable supply chains remains pivotal.

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Key Takeaways

• Leading Suppliers: Advanced Accelerator Applications (AAA) and Jubilant Radiopharma dominate the global supply chain for Iobenguane sulfate I-123 due to their certified manufacturing facilities and regulatory approvals.

• Manufacturing Complexity: Limited number of suppliers exists due to the complexity of isotope production, requiring specialized cyclotron infrastructure and stringent quality controls.

• Regulatory Impact: Approval status varies by region but is essential for market access; suppliers with FDA or EMA approval are preferred for clinical reliability.

• Market Trends: Regional manufacturing expansion and technological innovations aim to enhance supply stability and reduce costs, benefiting end-users.

• Supply Chain Strategy: Stakeholders should prioritize suppliers with proven regulatory compliance, reliable delivery, and manufacturing capacity aligned with clinical demand to ensure uninterrupted diagnostic imaging services.

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FAQs

1. What are the main factors to consider when sourcing I-123 MIBG?
Regulatory approval, manufacturing quality, supply reliability, cost, and logistical considerations such as isotope shelf-life.

2. Are there regional differences in I-123 MIBG suppliers?
Yes. AAA and Jubilant are primary global suppliers, while regional providers like Shandong Tokuyama serve local markets, with potential for export as regulatory environments evolve.

3. How does the regulatory approval process impact supply?
Certified approvals ensure product quality, safety, and efficacy, making approved suppliers more reliable. Regulatory hurdles can limit supply options and complicate import processes.

4. Will technological innovations improve I-123 MIBG supply?
Yes. Advances in cyclotron technology, automation, and regional production facilities are expected to enhance supply stability and reduce costs.

5. Can I-123 MIBG be sourced from research institutions or small suppliers?
Typically limited to research purposes; clinical use mandates GMP-certified, approved products due to safety and efficacy standards.

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Sources

[1] Advanced Accelerator Applications. (2022). Company profile and product offerings.
[2] Jubilant Radiopharma. (2023). Product portfolio and regulatory approvals.
[3] European Medicines Agency. (2023). Radiopharmaceutical approvals and guidelines.
[4] U.S. Food and Drug Administration. (2022). Approved radiopharmaceuticals.
[5] Market Analysis Reports. (2023). Global supply chain for nuclear medicine radiotracers.