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Last Updated: December 12, 2025

Suppliers and packagers for generic pharmaceutical drug: XENON XE-129 HYPERPOLARIZED


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XENON XE-129 HYPERPOLARIZED

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Polarean XENOVIEW xenon xe-129 hyperpolarized GAS;INHALATION 214375 NDA Polarean, Inc. 80534-0300-1 50 BAG in 1 CARTON (80534-0300-1) / 300 mL in 1 BAG 2022-12-23
Polarean XENOVIEW xenon xe-129 hyperpolarized GAS;INHALATION 214375 NDA Polarean, Inc. 80534-0500-1 50 BAG in 1 CARTON (80534-0500-1) / 500 mL in 1 BAG 2022-12-23
Polarean XENOVIEW xenon xe-129 hyperpolarized GAS;INHALATION 214375 NDA Polarean, Inc. 80534-0750-1 50 BAG in 1 CARTON (80534-0750-1) / 750 mL in 1 BAG 2022-12-23
Polarean XENOVIEW xenon xe-129 hyperpolarized GAS;INHALATION 214375 NDA Polarean, Inc. 80534-1000-1 50 BAG in 1 CARTON (80534-1000-1) / 1 L in 1 BAG 2022-12-23
Polarean XENOVIEW xenon xe-129 hyperpolarized GAS;INHALATION 214375 NDA Polarean, Inc. 80534-1000-2 50 BAG in 1 CARTON (80534-1000-2) / 1 L in 1 BAG 2022-12-23
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for the Pharmaceutical Drug: XENON XE-129 HYPERPOLARIZED

Last updated: July 29, 2025

Introduction

Xenon Xe-129 hyperpolarized is an advanced form of xenon used predominantly in medical imaging, molecular diagnosis, and research. Its unique hyperpolarized state significantly enhances magnetic resonance imaging (MRI) signals, enabling detailed visualization of biological processes and structures that conventional imaging techniques cannot elucidate effectively. As the demand for hyperpolarized xenon escalates within clinical and research settings, identifying key suppliers becomes crucial for pharmaceutical companies, research institutions, and healthcare providers seeking reliable, high-quality sources.

Overview of Hyperpolarized Xenon Xe-129

Xenon-129 (Xe-129) is a stable, non-radioactive isotope of xenon, prized in MRI applications due to its nuclear spin properties. Hyperpolarization refers to aligning the nuclear spins at a much higher degree than thermal equilibrium, resulting in a signal amplification typically exceeding 10,000-fold. The hyperpolarization process involves sophisticated techniques, such as spin-exchange optical pumping (SEOP), which require specialized infrastructure and expertise.

The primary purpose of hyperpolarized Xe-129 in pharmaceuticals and diagnostics lies in pulmonary imaging, brain studies, and functional assessments of various tissues. With the increasing adoption of these applications, suppliers offering high-purity, reliably hyperpolarized Xe-129 are becoming vital components of the supply chain.

Major Suppliers of Hyperpolarized Xe-129

1. Oxford Instruments (Polarization Division)

  • Overview: Oxford Instruments offers state-of-the-art systems for producing hyperpolarized Xe-129 using SEOP technology. Their Xe-129 Hyperpolarization System (e.g., the HyperSense™ polarizer) is among the most recognized globally.
  • Product offerings: Fully integrated hyperpolarization equipment, gas handling systems, and consumables.
  • Specialties: Custom solutions for research institutions and clinical facilities, providing scalable workflows.
  • Implication: Oxford’s longstanding expertise and extensive R&D have established it as a reliable supplier for high-purity hyperpolarized Xe-129.

2. XeSource (Part of Guerbet Group)

  • Overview: Guerbet, a global leader in contrast agents and imaging solutions, owns XeSource—dedicated to the production and supply of hyperpolarized Xe-129.
  • Product offerings: Ready-to-use hyperpolarized Xe-129 gas, designed for immediate clinical applications, especially in pulmonary MRI.
  • Advantages: Focused on scalable, clinical-grade supply, adhering to Good Manufacturing Practice (GMP) standards.
  • Implication: The entity bridges the gap between research and clinical deployment, emphasizing quality and regulatory compliance.

3. HyperSphere (SpinCore Technologies)

  • Overview: SpinCore Technologies markets hardware and services related to the hyperpolarization of gases, including Xe-129.
  • Product offerings: Spin-exchange optical pumping (SEOP) systems and hyperpolarized gas producing modules.
  • Specialties: Customizable hardware suited for research with potential for scaling into clinical environments.
  • Implication: Direct engagement with research labs and early-stage clinical initiatives.

4. Xemed LLC

  • Overview: Xemed specializes in providing hyperpolarized noble gases, with a focus on Xe-129 and helium-3.
  • Product offerings: Hyperpolarized Xe-129 gases produced via robust polarization systems, with supply tailored for MRI applications.
  • Strengths: Reliable high-volume production, support, and GMP-compliant processes.
  • Implication: A preferred supplier for clinical research and imaging centers seeking consistent, high-quality hyperpolarized gases.

5. Academic and Commercial Collaborators

Additional sources include research laboratories and niche manufacturers engaged in the hyperpolarized Xe-129 production, such as universities with dedicated hyperpolarization facilities or emerging biotech firms developing proprietary polarization techniques.

Market Dynamics and Supply Considerations

Hyperpolarized Xe-129 supply is inherently complex, involving advanced infrastructure, skilled personnel, and strict regulatory standards. The scarcity of large-scale commercial production facilities relative to demand means suppliers often provide customized or limited-quantity products.

The supply chain also faces challenges such as isotope availability, production costs, and maintenance of hyperpolarization during transportation. Suppliers that can reliably produce and deliver high-purity, hyperpolarized Xe-129 in a timely manner are positioned as strategic partners in the medical imaging sector.

Regulatory and Quality Standards

Suppliers compliant with FDA, EMA, and other regulatory authorities’ Good Manufacturing Practice (GMP) standards are preferred for clinical applications. Certifications and documented traceability of the hyperpolarized Xe-129 ensure safety, efficacy, and reproducibility, critical for pharmaceutical deployment.

Emerging Trends and Future Outlook

Innovations in polarization technology, miniaturization of hyperpolarization systems, and increased investment in nuclear magnetic resonance (NMR) research are expected to drive supply diversification. Several biotech startups are developing portable hyperpolarization units, which may lower barriers to widespread clinical adoption.

Furthermore, collaborations between technology providers and pharmaceutical manufacturers are focusing on integrating hyperpolarized Xe-129 into theranostic applications, expanding the market beyond imaging into targeted drug delivery and molecular diagnostics.


Key Takeaways

  • Global suppliers such as Oxford Instruments and Guerbet’s XeSource lead the market in hyperpolarized Xe-129 supply, offering high-purity gases and polarization systems.
  • The supply chain demands high technical expertise, GMP compliance, and robust infrastructure due to the complexity of hyperpolarization processes.
  • Clinical and research demand is fueling innovations, including portable systems and improved polarization techniques.
  • Regulatory standards, supply scalability, and cost considerations remain central to market dynamics.
  • Strategic partnerships with reliable suppliers are essential for pharmaceutical companies looking to incorporate hyperpolarized Xe-129 into their diagnostic arsenal.

Frequently Asked Questions

1. What applications necessitate the use of hyperpolarized Xe-129 in pharmaceuticals?
Hyperpolarized Xe-129 enhances MRI imaging resolution, enabling detailed visualization of pulmonary function, brain activity, and vascular structures for diagnostic and research purposes.

2. How do suppliers ensure the stability and quality of hyperpolarized Xe-129 during transportation?
Most suppliers utilize specialized transport containers, such as sealed, cryogenically cooled vessels, and coordinate with rapid delivery schedules to minimize polarization decay, ensuring product integrity.

3. Are there regulatory hurdles for pharmaceutical integration of hyperpolarized Xe-129?
Yes. Hyperpolarized Xe-129 intended for clinical use must meet rigorous FDA or EMA standards, including GMP certification, thorough validation, and safety assessments.

4. What are the cost implications of sourcing hyperpolarized Xe-129?
Costs vary based on product purity, volume, and polarization method, often ranging from thousands to tens of thousands of dollars per quantity, emphasizing the importance of reliable suppliers.

5. What innovations are expected to transform the supply landscape of hyperpolarized Xe-129?
Emerging portable polarization devices, automated production units, and improved stabilization techniques will enhance accessibility, reduce costs, and expand use cases.


References

[1] Oxford Instruments. Hyperpolarization Systems for Noble Gases. Oxford Instruments. Retrieved 2023.
[2] Guerbet Group. XeSource Clinical Hyperpolarized Xenon. Guerbet official resources.
[3] SpinCore Technologies. Hyperpolarized Gas Production Hardware. SpinCore product catalog.
[4] Xemed LLC. High-Quality Hyperpolarized Noble Gases. Xemed official documentation.
[5] Market Reports & Industry Analyses. Various industry publications on hyperpolarized gas supply and MRI applications.


This comprehensive overview equips pharmaceutical and research professionals with insights into leading suppliers of hyperpolarized Xe-129, supporting informed decision-making in procurement and development strategies.

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