INDIUM IN-111 OXYQUINOLINE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bwxt Itg	INDIUM IN 111 OXYQUINOLINE	indium in-111 oxyquinoline	INJECTABLE;INJECTION	202586	ANDA	BWXT Medical Ltd.	72536-0920-1	1 mL in 1 VIAL, SINGLE-DOSE (72536-0920-1)	2019-09-27
Ge Healthcare	INDIUM IN 111 OXYQUINOLINE	indium in-111 oxyquinoline	INJECTABLE;INJECTION	019044	NDA	Medi-Physics Inc. dba GE Healthcare.	17156-021-01	1 VIAL in 1 BOX (17156-021-01) / 1 mL in 1 VIAL	1985-12-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Indium-111 Oxine (In-111 Oxine) is a specialized radiopharmaceutical widely utilized in nuclear medicine, primarily for cell labeling and imaging applications. It enables the visualization of physiological processes through scintigraphy, including infection localization, tumor tracking, and hematopoietic cell migration. The complex chemistry of Indium-111, combined with the lipophilic oxine (8-hydroxyquinoline) carrier, allows the labeling of leukocytes and other cells with high stability and specificity.

Securing reliable suppliers for In-111 Oxine is critical for pharmaceutical companies, nuclear medicine laboratories, and research institutions engaged in diagnostic imaging. Given the intricacies of production, licensing, and handling radioactive materials, understanding supplier landscape, quality standards, and regulatory compliance is vital for operational success.

Manufacturers and Suppliers of Indium-111 Oxine

Due to the radioactive nature of In-111, its procurement involves strict regulatory controls, licensing, and adherence to safety protocols. Consequently, the market for In-111 Oxine is relatively concentrated, with few manufacturers globally capable of producing pharmaceutical-grade radiopharmaceuticals.

1. Covidien (Part of Medtronic)

Historically, Covidien supplied radiopharmaceuticals, including Indium-111 compounds, to global markets. However, their focus shifted after acquisition by Medtronic, leading to the sale of some radiopharmaceutical assets. Their involvement in In-111 Oxine production has diminished; nonetheless, their legacy products are still referenced in certain regions.

2. GE Healthcare

GE Healthcare is a prominent player in nuclear medicine, providing a series of radiopharmaceuticals, including In-111-based tracers. Although GE does not typically produce In-111 Oxine directly, they facilitate access through partnerships and licensed distribution channels, especially in regions where they operate radiochemistry manufacturing facilities. Their global distribution network ensures reliable supply chains.

3. Lantheus Medical Imaging

Lantheus is a leading manufacturer of radiopharmaceuticals including Indium-111-labeled compounds like Indium In-111 Pentetate (e.g., DTPA). While they mainly focus on diagnostic tracers, they do not directly manufacture In-111 Oxine but act as distributors or sublicensees for the raw In-111 isotopes, which are essential for compounding and formulating In-111 Oxine locally.

4. IAEA (International Atomic Energy Agency)

While not a commercial supplier, IAEA provides guidelines, quality standards, and sometimes facilitates the procurement of radioisotopes for research institutions. They do not produce or supply In-111 Oxine directly but are instrumental in establishing nuclear medicine radiation safety and standards, impacting procurement decisions globally.

5. Radiofarm-Industries or Custom Compounders

Several specialized radiopharmacies and contract manufacturers, particularly in Europe and North America, import raw In-111 isotopes from established nuclear reactors (e.g., Canberra, CNEA, or IRE facilities) and formulate In-111 Oxine under Good Manufacturing Practice (GMP) conditions. Notable entities include:

In-111 Radioisotope Providers: Companies such as MDS Nordion (now part of Nordion, a Sotera Health company), supply high-purity In-111 isotopes, which are then shipped to compounding facilities.
Contract Radiopharmacies: They synthesize In-111 Oxine in compliance with regulatory standards, often serving academic or hospital-based imaging centers.

6. Academic and Governmental Institutions

In many instances, In-111 Oxine formulations are produced within university radiochemistry labs or government nuclear medicine centers, especially for research purposes, due to regulatory and safety hurdles in commercial distribution.

Manufacturing and Distribution Challenges

The production of In-111 Oxine involves complex radiochemistry processes:

Isotope Production: In-111 is generated via nuclear reactors, typically through the irradiation of enriched zinc targets, then purified for medical use.
Compound Preparation: The radiolabeling process involves high-purity In-111 chloride reacting with oxine under controlled conditions to form In-111 Oxine, which must be sterile, pyrogen-free, and compliant with pharmacopeial standards.
Regulatory Compliance: Manufacturers must hold appropriate licenses from nuclear safety authorities, such as the U.S. Nuclear Regulatory Commission (NRC) or European Medicines Agency (EMA), due to radioactivity handling.
Shelf Life and Logistics: In-111's half-life (~67 hours) demands rapid distribution channels, often necessitating regional manufacturing units or centralized suppliers with robust logistics.

Market Dynamics and Procurement Strategies

Given the limited number of dedicated suppliers and the highly regulated nature of radioactive pharmaceuticals, procurement of In-111 Oxine often relies on:

International Atomic Energy Agency (IAEA) compliance: For research and non-clinical applications, IAEA databases assist in sourcing isotopes from licensed producers.
Regional Suppliers: Organizations in North America (Nordion), Europe (Advanced Accelerator Applications, now part of Novartis), and Asia distribute high-grade In-111 isotopes to licensed compounding pharmacies.
In-house Radiochemistry: Hospitals and research centers with appropriate facilities often produce In-111 Oxine on-site through licensed radiochemists, which provides continuity but involves significant regulatory oversight.

Regulatory Considerations

Maintaining compliance is critical when sourcing In-111 Oxine:

Licenses for handling, storage, and transportation of radioactive materials are mandatory.
Establishing Good Manufacturing Practice (GMP) standards ensures product safety and efficacy.
International regulations, such as those from the U.S. FDA or EMA, govern clinical use and manufacturing practices.
Cross-border transportation of radioactive materials necessitates adherence to international safety and customs protocols.

Future Outlook and Emerging Suppliers

The global nuclear medicine market is anticipated to grow due to advances in personalized diagnostics and theranostics. This shift may incentivize new entrants into the supply chain, including:

Novel radiochemistry manufacturers investing in reactor-produced isotopes.
Regional production hubs to improve supply consistency amid the isotope shortfall concerns.
Research collaborations to develop alternative cell-labeling agents with longer shelf life or easier handling.

However, the constraints of isotope supply and regulatory hurdles will likely sustain market dominance by existing specialized suppliers.

Conclusion

Procurement of Indium-111 Oxine hinges on navigating a niche, highly regulated market dominated by few key suppliers. Organizations typically source In-111 isotopes from major nuclear reactor providers, then conduct in-house or contracted formulation under strict safety and quality standards. The evolving landscape suggests potential diversification through emerging regional manufacturers and new radiochemistry technologies, but regulatory compliance remains paramount.

Key Takeaways

The In-111 Oxine market is characterized by limited commercial suppliers, primarily originating from isotope producers and specialized radiopharmacies.
Major suppliers include Nordion (Canada), Advanced Accelerator Applications (France), and regional nuclear medicine facilities capable of in-house formulation.
Regulatory compliance, license acquisition, and logistics are critical components of procurement.
The supply chain's complexity necessitates early planning, especially given In-111's short half-life.
Emerging demands for personalized imaging and theranostics could augment future supplier options but will still face regulatory and logistical barriers.

FAQs

1. Who are the primary global suppliers of Indium-111 isotopes used in In-111 Oxine?
Nordion (Canada), CNEA (Argentina), and Cintichem (USA) are among key producers of high-purity In-111 isotopes. These isotopes are then distributed for various radiopharmaceutical preparations.

2. Can I purchase In-111 Oxine directly from manufacturers?
Direct procurement is generally limited to licensed nuclear medicine facilities or contract radiopharmacy providers. Commercial supply of pre-made In-111 Oxine is rare, with most organizations producing it in-house from high-purity In-111 isotopes.

3. What regulatory considerations exist for sourcing and using In-111 Oxine?
Regulatory bodies such as the FDA (USA), EMA (Europe), and equivalent agencies in other countries require appropriate licensing for handling radioactive materials, GMP compliance, and adherence to transportation safety standards.

4. Are there alternative radiolabeling agents to In-111 Oxine?
Yes, alternatives like Technetium-99m-based agents or other radiolabeled compounds are emerging, but In-111 Oxine remains preferred for specific cell-labeling applications due to its stability and imaging properties.

5. How does isotope supply impact the clinical and research use of In-111 Oxine?
Limited isotope supply can cause delays and increased costs. Ensuring a reliable партнерство agreement with licensed suppliers and establishing in-house production capabilities are key strategies to mitigate supply chain disruptions.

References

[1] International Atomic Energy Agency (IAEA). "Radioisotope Production and Quality Control." IAEA Publications, 2020.
[2] Nordion (Canada). "Indium-111 (In-111) Product Specifications." Nordion, 2022.
[3] European Medicines Agency (EMA). "Guidelines on Good Manufacturing Practice for Radiopharmaceuticals." EMA, 2019.
[4] CNEA, Argentina. "Radioisotope Production Facilities." CNEA Annual Report, 2021.
[5] International Nuclear Safety Standards. IAEA Safety Standards Series, 2018.

Suppliers and packagers for generic pharmaceutical drug: INDIUM IN-111 OXYQUINOLINE