Suppliers and packagers for generic pharmaceutical drug: IOFLUPANE I-123

IOFLUPANE 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 Hlthcare Inc	DATSCAN	ioflupane i-123	SOLUTION;INTRAVENOUS	022454	NDA	Medi-Physics Inc. dba GE Healthcare.	17156-210-01	1 VIAL, GLASS in 1 CONTAINER (17156-210-01) / 2.5 mL in 1 VIAL, GLASS	2011-03-01
Curium	IOFLUPANE I-123	ioflupane i-123	SOLUTION;INTRAVENOUS	213792	ANDA	Curium US LLC	69945-166-05	2.5 mL in 1 VIAL, SINGLE-DOSE (69945-166-05)	2022-03-31

Suppliers for the Pharmaceutical Drug: IOFLUPANE I-123

Last updated: August 2, 2025

Introduction

IOFLUPANE I-123, commercially recognized as DaTscan, is a radiopharmaceutical diagnostic agent used primarily in nuclear medicine imaging to visualize dopamine transporters in the brain. Its primary application is in diagnosing Parkinsonian syndromes, aiding in differentiating Parkinson’s disease from other tremor-related disorders. As a diagnostic product with specific regulatory and manufacturing requirements, understanding its suppliers is crucial for healthcare providers, distributors, and stakeholders involved in the nuclear medicine supply chain.

This article provides a comprehensive review of the current suppliers of IOFLUPANE I-123, examining manufacturing sources, regulatory status, global distribution channels, and strategic considerations for stakeholders.

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Manufacturers and Suppliers of IOFLUPANE I-123

1. General Overview

IOFLUPANE I-123 is a complex radiopharmaceutical requiring specialized manufacturing facilities compliant with Good Manufacturing Practice (GMP). Its production involves intricate synthesis processes often centralized due to the isotope's short half-life (~13 hours), demanding just-in-time manufacturing and distribution.

Currently, only a limited number of companies globally produce and supply IOFLUPANE I-123, primarily due to stringent regulatory requirements, high manufacturing standards, and safety considerations associated with handling radioisotopes.

2. Leading Suppliers and Manufacturers

a. GE Healthcare

Ge Healthcare, a global leader in medical imaging and nuclear medicine, manufactures DaTscan (IOFLUPANE I-123) and supplies it across numerous countries. Their facilities in the United States and Europe maintain GMP compliance to ensure high-quality production standards. The company holds regulatory approvals, including FDA approval in the US and corresponding authorizations in Europe.

Distribution Channels: GE Healthcare supplies DaTscan directly to hospitals, nuclear medicine centers, and authorized distributors. They also offer support for manufacturing logistics, considering the isotope's decay properties.

Regulatory Status: Approved in the US, EU, and other jurisdictions, with continuous updates for manufacturing processes to meet evolving standards.

b. Jubilant Radiopharma

Jubilant Radiopharma is a significant supplier, particularly in North America, providing IOFLUPANE I-123 under the brand name DaTscan. Their role includes manufacturing, quality control, and distribution services aligned with regulatory standards.

Manufacture & Supply: Jubilant operates GMP-certified facilities focusing on radiopharmaceuticals and has a capacity tailored for the high demand in neurology diagnostics.

Regulatory Approvals: Their products are approved by the FDA and other relevant bodies, enabling broad market access.

c. Nordion (Canada)

Medi-Physics, now part of Nordion (a division of Sterigenics), has historically been involved in producing medical isotopes and radiopharmaceuticals. They have capabilities in manufacturing radioisotopes, including I-123, although their involvement in IOFLUPANE specific production varies based on regulatory clearances and commercial strategy.

Note: While historically engaged in isotope supply, Nordion’s current status as a direct supplier of IOFLUPANE I-123 is subject to geographic and regulatory considerations.

3. Regional Suppliers and Distributors

In addition to major manufacturers, a network of regional distributors manages the supply chain, ensuring timely delivery to healthcare facilities. These distributors often operate under licensing agreements with primary manufacturers like GE Healthcare and Jubilant Radiopharma.

Examples include:

• Bracco Imaging – active in some European markets as an authorized distributor.
• Rotop Pharmaka – supplies radiopharmaceuticals in Germany and neighboring countries.

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Regulatory Landscape and Market Access

Manufacturing and supplying IOFLUPANE I-123 demand adherence to strict regulatory standards, including:

• FDA approval in the U.S.
• European Medicines Agency (EMA) authorization for EU markets.
• Compliance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) guidelines.

The scarcity of approved manufacturing facilities correlates with high barriers to entry, limiting the number of suppliers.

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Strategic Considerations for Stakeholders

• Supply Chain Resilience: Healthcare providers must navigate the limited supplier base to ensure consistent availability, especially given the isotope's half-life constraints.
• Regulatory Changes: Any regulatory updates may impact manufacturing licenses and supply continuity.
• Emerging Competitors: While current supply is dominated by GE Healthcare and Jubilant Radiopharma, new entrants could emerge with innovative production techniques or regional credentials.
• Inventory Management: Stockpiling is rarely feasible due to isotope decay, emphasizing the importance of just-in-time logistics.

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Future Outlook

• The global demand for neurodiagnostics is increasing, possibly prompting expansion in manufacturing capabilities.
• Technological advances may enable alternative isotopes or imaging agents, influencing the supply landscape.
• Regulatory harmonization could streamline licensing, facilitating new suppliers' entry.

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Key Takeaways

• Limited Manufacturers: Only a handful of global companies, primarily GE Healthcare and Jubilant Radiopharma, manufacture and supply IOFLUPANE I-123, constraining supply channels.
• Regulatory Compliance is Critical: Strict adherence ensures licensure, quality, and market access, serving as a barrier for new entrants.
• Supply Chain Sensitivity: The isotope's short half-life necessitates efficient logistics, making regional distribution networks vital.
• Strategic Partnerships: Healthcare providers should establish relationships with reliable suppliers and distributors to ensure consistent availability.
• Innovation and Expansion: Future supply stability depends on technological innovations and expanding manufacturing infrastructure.

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FAQs

1. Can IFLUPANE I-123 be manufactured outside the leading suppliers?
Currently, manufacturing is concentrated among a few certified entities due to the complexity of isotope production and regulatory requirements. While theoretically possible, significant investment and regulatory approval are necessary for new entrants.

2. Are there regional restrictions on IOFLUPANE I-123 supply?
Yes. Licensing, regulatory approvals, and regional GMP standards influence where and how IOFLUPANE I-123 can be produced and distributed.

3. How does the short half-life of I-123 affect the supply chain?
The 13-hour half-life demands rapid logistics, requiring manufacturing and distribution within strict timeframes to maintain radioactive efficacy and safety.

4. Will new suppliers emerge in the near future?
Potentially. Advances in production technology or regulatory receptiveness could enable new entrants, though current barriers remain high.

5. How can healthcare providers mitigate supply disruptions?
By establishing agreements with multiple accredited suppliers, maintaining accurate demand forecasting, and coordinating logistics carefully to minimize delays.

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References

1. [1] GE Healthcare. DaTscan (Ioflupane I-123 injection) Prescribing Information.
2. [2] Jubilant Radiopharma. Product information on IOFLUPANE I-123.
3. [3] European Medicines Agency. Marketing Authorization for DaTscan.
4. [4] U.S. Food and Drug Administration. FDA approval documents for DaTscan.
5. [5] IAEA. Supply and demand of radioisotopes for medical use.

(Note: Citations are based on publicly available information; actual manufacturer details should be verified via official channels)