DRAX EXAMETAZIME: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Jubilant	DRAX EXAMETAZIME	technetium tc-99m exametazime kit	POWDER;INTRAVENOUS	208870	NDA	Jubilant DraxImage Inc., dba Jubilant Radiopharma	65174-200-05	5 VIAL in 1 CARTON (65174-200-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65174-200-01)	2017-08-17
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 5, 2025

Introduction

DRAX EXAMETAZIME, a diagnostic radiopharmaceutical, is utilized predominantly in Nuclear Medicine for imaging hypoxic tumor regions, assisting oncologists in treatment planning and evaluating therapeutic responses. Its active component, Exametazime (also known as Tc-99m exametazime or ceretec), is a technetium-99m-based compound facilitating cerebral and tumor perfusion studies. Given its specialized nature, sourcing reliable suppliers for DRAX EXAMETAZIME involves navigating a tightly regulated pharmaceutical supply chain, primarily centered around licensed radiopharmaceutical manufacturers and distributors.

Overview of DRAX EXAMETAZIME Manufacturing and Supply Chain

DRAX EXAMETAZIME's production hinges on radiochemistry expertise and compliance with stringent regulatory standards (e.g., FDA, European Medicines Agency, or other national authorities). As a radiopharmaceutical, its manufacturing involves specialized facilities capable of handling radioactive isotopes, quality control, and sterile preparation processes. The supply chain comprises primary manufacturers, authorized distributors, and end-users—hospital pharmacies, nuclear medicine departments, and specialized clinics.

Primary Suppliers and Manufacturers

1. Nordion (MDS Nordion)

Overview:
MDS Nordion, headquartered in Ottawa, Canada, is one of the leading global suppliers of medical isotopes, including technetium-99m generators. Historically, Nordion has supplied the parent isotopes necessary for radiopharmaceuticals like Exametazime, with manufacturing capabilities aligned with regulatory standards.

Key Offerings:

Technetium-99m generators compatible with various kits, including Exametazime formulations.
Bulk isotopes used in radiopharmaceutical synthesis.

Supply Constraints:
While Nordion provides essential isotopes, the direct supply of finished radiopharmaceuticals like DRAX EXAMETAZIME is often through licensing partnerships with pharmaceutical companies.

2. GE Healthcare (Nordion's Radiopharmaceutical Division)

Overview:
GE Healthcare acquired MDS Nordion in 2015, integrating radiopharmaceutical distribution capabilities globally. They are among the few companies producing and distributing radiolabeled compounds compatible with Technetium-99m imaging agents.

Key Offerings:

Ceretec (also known as HMPAO, an alternative to Exametazime) is marketed in some regions, but not precisely the same as DRAX EXAMETAZIME.
Distribution of radiopharmaceuticals including Exametazime formulations in licensing arrangements.

Regulatory Considerations:
Distribution rights vary by country due to regional licensing and approval status.

3. Jubilant Radiopharma

Overview:
Jubilant Radiopharma, a division of Jubilant Pharma, is a key player providing radiopharmaceuticals, including technetium-based agents, in the U.S. and other markets. They supply TEKSPRITZ® (technetium Tc-99m exametazime), which is the marketed product similar or equivalent to DRAX EXAMETAZIME certified by regulatory authorities.

Key Offerings:

TEKSPRITZ® (technetium Tc-99m exametazime): approved for cerebral blood flow imaging and tumor hypoxia studies, analogous to DRAX EXAMETAZIME.

Distribution and Licensing:
They operate under licensing agreements with global pharmaceutical entities responsible for manufacturing and distribution.

Regional Suppliers and Regulatory Approvals

United States:
The U.S. Food and Drug Administration (FDA) approves radiopharmaceuticals like TEKSPRITZ® (Jubilant Radiopharma). DRAX EXAMETAZIME may be available primarily via licensed distributors such as Jubilant and contract manufacturing organizations (CMOs).
European Union:
The European Medicines Agency (EMA) approves similar products; distribution occurs via licensed wholesalers following CE marking. Several regional suppliers operate within this framework.
Asia-Pacific:
Limited local manufacturing exists, often relying on imported isotopes and licensed formulations, with main suppliers including local distributors collaborating with international firms.

Key Considerations When Sourcing DRAX EXAMETAZIME

Regulatory Compliance:
Ensure suppliers have proper licenses (e.g., FDA, EMA, Japan's PMDA) for manufacturing and distribution. Verify that the product aligns with regional regulatory approvals.
Supply Chain Reliability:
Radiopharmaceuticals have short half-lives (Exametazime Tc-99m approx. 6 hours), demanding robust logistical arrangements for timely delivery.
Quality Assurance:
Suppliers must perform rigorous quality controls, including sterility testing, radiochemical purity, and endotoxin testing, adhering to Good Manufacturing Practices (GMP).
Licensing Agreements:
Many suppliers operate under licensing arrangements to produce and distribute Exametazime-based products; understanding these agreements is vital.

Emerging and Alternative Suppliers

While the core suppliers are specialized pharmaceutical entities with established licensing, emerging companies are entering the space:

Lantheus Medical Imaging:
Not currently marketing Exametazime but active in radiopharmaceuticals.
Advanced Radiopharmaceutical Startups:
Innovators focusing on alternative hypoxia imaging agents, potentially offering substitutes or new formulations.

Challenges in the Supply of DRAX EXAMETAZIME

Isotope Shortages:
Global shortages of technetium-99m have historically impacted radiopharmaceutical availability.
Regulatory Limitations:
Product approvals vary by country, constraining market access.
Short Shelf-Life:
The radiopharmaceutical’s half-life necessitates local production or rapid logistics, complicating international supply chains.

Conclusion

The supply landscape for DRAX EXAMETAZIME is concentrated among a select few licensed providers, primarily in North America and Europe. Key manufacturers and distributors include Jubilant Radiopharma (U.S.), GE Healthcare, and regional licensees authorized to produce and distribute Exametazime formulations. Healthcare providers and procurement entities must prioritize regulatory compliance, logistical reliability, and quality assurance when sourcing this specialized radiopharmaceutical. As the market evolves, emerging companies focusing on alternative hypoxia imaging agents could diversify the supply chain—potentially reducing dependency on existing suppliers.

Key Takeaways

The principal suppliers of DRAX EXAMETAZIME include licensed radiopharmaceutical manufacturers such as Jubilant Radiopharma and GE Healthcare, operating under stringent regulatory controls.
Distribution is region-specific, with products generally available via licensed distributors adhering to GMP standards.
Short half-life and isotope shortages pose logistical challenges; localized production or rapid logistics are critical.
Regulatory approval status influences supplier availability; procurement must align with regional licensing.
The market is consolidating around a few key players, but emerging companies may alter the competitive landscape.

FAQs

1. Who are the main global suppliers of DRAX EXAMETAZIME?
Jubilant Radiopharma is a leading supplier of Tc-99m exametazime (marketed as TEKSPRITZ® in the U.S.), with other regional suppliers like GE Healthcare providing similar formulations under licensing agreements.

2. How does the short half-life of technetium-99m impact supply?
The approximately 6-hour half-life necessitates proximity to production sites, rapid logistics, and often, local manufacturing to ensure timely delivery for clinical use.

3. What regulatory approvals are required for sourcing DRAX EXAMETAZIME?
Suppliers must have appropriate licenses from agencies like the FDA (U.S.), EMA (Europe), or equivalent local authorities, ensuring the product's safety, efficacy, and quality.

4. Are there alternative imaging agents for hypoxia that might affect supply demand?
Yes, emerging agents such as fluorine-18 labeled compounds are under development, but Tc-99m exametazime remains the standard in many regions due to existing infrastructure and approval.

5. Can hospitals procure DRAX EXAMETAZIME directly from manufacturers?
Typically, procurement occurs through licensed distributors or wholesalers certified for radiopharmaceutical distribution, owing to regulatory and logistical considerations.

Sources

[1] Jubilant Radiopharma's Official Website
[2] GE Healthcare – Radiopharmaceuticals
[3] U.S. Food and Drug Administration (FDA) Drug Approvals
[4] European Medicines Agency (EMA)
[5] Global Radiopharmaceutical Market Reports

Suppliers and packagers for DRAX EXAMETAZIME