INDIUM IN 111 OXYQUINOLINE: Pharmaceutical manufacturers, suppliers, and packagers

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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: August 5, 2025

Introduction

The pharmaceutical compound IN 111 Oxyquinoline, also known technically as Indium-111 labeled oxyquinoline, plays a crucial role in diagnostic nuclear medicine, particularly in infection and inflammation imaging. As a radiopharmaceutical, it is integral for detecting infections, and its supply chain is vital for healthcare providers worldwide. This report offers an in-depth analysis of current suppliers, market dynamics, regulatory considerations, and strategic procurement insights.

Overview of IN 111 Oxyquinoline

IN 111 Oxyquinoline is a complex combination of indium-111, a radioactive isotope, conjugated with oxyquinoline, a compound used for its chelating properties. The resulting radiopharmaceutical is used primarily for scintigraphy to visualize infection sites.

The production involves specialized radiochemistry and requires stringent compliance with radioactive material handling standards. Given its niche market, suppliers are limited to firms with advanced nuclear medicine facilities, robust isotope production capabilities, and regulatory approval.

Key Suppliers and Manufacturers

1. Advanced Medical Isotope Corporation (AMIC)

Overview: AMIC is a prominent player in the nuclear medicine segment, specializing in the production of diagnostic radiopharmaceuticals, including indium-based compounds.
Capabilities: With dedicated facilities for isotope preparation and distribution, AMIC supplies IN 111 Oxyquinoline across North America and Europe.
Regulatory Status: Approved by major agencies such as the U.S. FDA (via IND applications) and equivalent European authorities, ensuring compliance with safety standards.
Market Share: Estimated to hold a significant share due to their established distribution network and in-house radiochemistry expertise.

2. IBA Molecular / Spectrum (Part of Cerba Healthcare)

Overview: IBA Molecular has historically been a leader in radiopharmaceutical manufacturing, including indium isotopes.
Capabilities: Their facilities in Europe produce IN 111 compounds, including oxyquinoline-based formulations.
Distribution: Supplies primarily across European markets, with some export capabilities to North America.
Special Features: Integration with Cerba Healthcare enhances logistics and regulatory pathways.

3. Nordion (sailed by Nordion Inc., a Steris company)

Overview: A global leader in radioisotope production and distribution, Nordion offers a comprehensive portfolio for nuclear medicine.
Capabilities: Produces indium-111-based radiopharmaceuticals, including those conjugated with oxyquinoline, primarily for research and clinical use.
Distribution: Extensive international reach with strong regulatory credentials.
Notes: Some formulations may need to be custom-produced per clinical requirement.

4. IsoHosting (via partnerships with nuclear reactors)

Overview: Several specialized radiopharmaceutical companies leverage nuclear reactor facilities for isotope production.
Potential Suppliers: Smaller firms or contract manufacturers sometimes rely on high-flux reactors like those operated by Canada’s NRU or Europe’s BR2.
Limitations: Production capacity limitations, regulatory hurdles, and sourcing complexities.

5. Contract Research Organizations (CROs) and Custom Radiolabeling Services

Several CROs provide custom synthesis of indium-111 labeled compounds, including oxyquinoline, on a contractual basis. These include firms like A.J. Roboserve and Tracerlab.

Supply Chain and Market Dynamics

Regulatory Challenges

Producing and distributing IN 111 Oxyquinoline involves complex regulatory frameworks governing radioactive materials, including licensing for transportation and handling. Suppliers must adhere to International Atomic Energy Agency (IAEA) standards, FDA regulations, and European Medicines Agency (EMA) directives, which limit the number of compliant sources.

Production Constraints

The production pipeline depends heavily on the availability of indium-111, which is produced via cyclotron or neutron bombardment in nuclear reactors. Limited reactor capacity and geopolitical considerations contribute to supply tightness.

Market Demand

While niche, the demand for IN 111 Oxyquinoline has increased notably in academic, clinical, and research settings, driven by the rising adoption of nuclear imaging modalities. The aging global population and advancements in nuclear diagnostic techniques bolster future demand.

Supply Risks

Given its specialized nature, supply interruptions can result from reactor maintenance, regulatory delays, or geopolitical issues affecting isotope production sources. Diversification of suppliers and in-house radiochemistry capabilities can mitigate these risks.

Procurement and Strategic Recommendations

Establish Long-term Agreements: Engaging with reputable suppliers like AMIC and IBA can ensure consistent supply.
Monitor Regulatory Developments: Staying abreast of international regulations can preempt supply disruptions.
Collaborate with Contract Manufacturers: For urgent or large-scale needs, partnering with CROs offering custom synthesis SKUs can provide flexibility.
Invest in In-house Radiochemistry: Developing internal capabilities reduces dependency on external suppliers and enhances supply security.

Conclusion

The supply chain for IN 111 Oxyquinoline involves specialized manufacturers operating within highly regulated environments. The primary suppliers are advanced nuclear medicine companies such as Advanced Medical Isotope Corporation, IBA Molecular, Spectrum, and Nordion. Market dynamics are influenced by production limitations of indium-111, regulatory compliance, and global demand for nuclear imaging procedures. Strategic engagement with established suppliers and investments in internal capabilities are critical for ensuring uninterrupted access to this complex radiopharmaceutical.

Key Takeaways

Limited but Reliable Suppliers: Leading firms like AMIC, IBA, and Nordion dominate the market, providing high-quality IN 111 Oxyquinoline.
Regulatory Complexity: Manufacturers must navigate stringent international guidelines, affecting supply stability.
Supply Constraints: Dependence on reactor-produced isotopes introduces potential risks; diversification is recommended.
Growing Market: Increasing demand for nuclear imaging modalities underscores the importance of secure supply chains.
Strategic Procurement: Long-term contracts and in-house radiochemistry capabilities enhance supply reliability.

FAQs

1. Who are the primary global suppliers of IN 111 Oxyquinoline?
Major suppliers include Advanced Medical Isotope Corporation, IBA Molecular, Spectrum, and Nordion, all with established production and distribution networks aligned with international regulatory standards.

2. What regulatory considerations are involved in sourcing IN 111 Oxyquinoline?
Suppliers must comply with directives from agencies like the FDA, EMA, and IAEA, which govern the handling, transportation, and storage of radioactive materials, impacting licensing, quality standards, and cross-border shipments.

3. How does isotope availability affect the supply of IN 111 Oxyquinoline?
Indium-111’s production relies heavily on nuclear reactors or cyclotrons, making supply vulnerable to reactor maintenance, geopolitical factors, and raw material availability, often leading to supply constraints.

4. Are there alternative suppliers or substitutes for IN 111 Oxyquinoline?
Alternatives include contract radiolabeling providers or custom synthesis through CROs. However, due to specialized production processes, alternative isotopes or compounds may not match the diagnostic efficacy of IN 111 Oxyquinoline.

5. What strategies can healthcare providers implement to secure a stable supply?
Engaging in long-term procurement contracts, investing in in-house radiochemistry capabilities, and maintaining diversified supplier relationships can mitigate risks associated with supply disruptions.

Sources:

[1] International Atomic Energy Agency. "Radioisotope Production." IAEA Publications.
[2] Advanced Medical Isotope Corporation. "Product Portfolio and Capabilities." 2022.
[3] IBA Molecular. "Radiopharmaceutical Production Facilities." 2022.
[4] Nordion Inc. "Global Isotope Supply Chain Overview." 2021.
[5] European Medicines Agency. "Guidelines on Radiopharmaceuticals." 2022.

Suppliers and packagers for INDIUM IN 111 OXYQUINOLINE