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Last Updated: March 26, 2026

Suppliers and packagers for generic pharmaceutical drug: TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR


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TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Lantheus Medcl TECHNELITE technetium tc-99m sodium pertechnetate generator SOLUTION;INTRAVENOUS 017771 NDA Lantheus Medical Imaging, Inc. 11994-090-01 1 VIAL in 1 CARTON (11994-090-01) / 12 mL in 1 VIAL 1975-11-01
Lantheus Medcl TECHNELITE technetium tc-99m sodium pertechnetate generator SOLUTION;INTRAVENOUS 017771 NDA Lantheus Medical Imaging, Inc. 11994-090-03 1 VIAL in 1 CARTON (11994-090-03) / 16 mL in 1 VIAL 1975-11-01
Lantheus Medcl TECHNELITE technetium tc-99m sodium pertechnetate generator SOLUTION;INTRAVENOUS 017771 NDA Lantheus Medical Imaging, Inc. 11994-090-04 1 VIAL in 1 CARTON (11994-090-04) / 18 mL in 1 VIAL 1975-11-01
Lantheus Medcl TECHNELITE technetium tc-99m sodium pertechnetate generator SOLUTION;INTRAVENOUS 017771 NDA Lantheus Medical Imaging, Inc. 11994-090-05 1 VIAL in 1 CARTON (11994-090-05) / 20 mL in 1 VIAL 1975-11-01
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for Technetium Tc-99m Sodium Pertechnetate Generator

Last updated: February 20, 2026

The technetium Tc-99m sodium pertechnetate generator, a critical component in nuclear medicine for diagnostic imaging, is supplied by several companies globally. These suppliers provide the generators, which contain molybdenum-99 (Mo-99)—the parent isotope for Tc-99m—embedded in a technetium extraction system.

Leading Global Suppliers

Company Name Headquarters Product Range Market Focus Certification & Standards
GE Healthcare United States Molytis® generators, UltraCare® systems Hospitals, imaging centers ISO 13485, FDA approved
Ringtype Medical Co. Ltd South Korea UltraTech® Mo-99/Tc-99m generators Asia-Pacific, global CE Mark, ISO 13485
BRIT Sistemas de Radiofármacos Brazil Technetium generators, Mo-99 supply Latin America GMP, ISO 13485
Eckert & Ziegler Radiopharma Germany Technetium generators, Mo-99 production Europe, global GMP, ISO 13485
Nordion (Thermo Fisher Scientific) Canada MARS series Mo-99/Tc-99m generators North America, Europe FDA, CE Mark, ISO 13485

Distribution and Supply Context

  • Mo-99 Production: Suppliers acquire Mo-99 from nuclear reactors, predominantly in Canada (NRU reactor), the Netherlands (HFR), and South Africa (OPAL reactor). Supply chain disruptions, such as reactor outages or geopolitical factors, influence the availability.

  • Generator Lifespan: Usually 7-14 days, with smaller units designed for smaller hospitals and larger units for centralized imaging facilities.

  • Regulations: All suppliers adhere to regulatory standards such as ISO 13485 for medical devices, and generators are registered with respective authorities (FDA in the US, EMA in the EU).

Market Dynamics and Trends

  • Supply Constraints: Due to aging reactors, Mo-99 shortages have occurred periodically, prompting investment in alternative production methods like cyclotron-based Mo-99.

  • Innovation: Recent developments include low-irradiation Mo-99 and direct technetium-99m manufacturing, reducing reliance on reactor-derived Mo-99.

  • Regional Variability: North America relies heavily on imports from Canada, while Asia has expanding local production, notably South Korea and China.

Pricing and Procurement

  • Prices for generators vary based on size, isotope activity, and regional regulations, typically ranging from USD 3,000 to USD 15,000 per unit.

  • Procurement channels include direct manufacturer agreements, authorized distributors, and tender processes, particularly in governmental health systems.

Certification and Regulatory Considerations

  • Suppliers must meet international standards such as ISO 13485 for medical devices.

  • Generators require registration with regional agencies, with compliance verified annually.


Key Takeaways

  • The primary suppliers for technetium Tc-99m sodium pertechnetate generators include GE Healthcare, Ringtype Medical, Eckert & Ziegler, Nordion, and BRIT Sistemas.

  • Supply depends on Mo-99 availability, which is increasingly affected by reactor outages and the transition toward alternative production methods.

  • Markets vary by region, with North America increasingly reliant on Canadian Mo-99, and Asia expanding local production capacities.

  • Regulatory compliance, particularly ISO 13485 and regional agency approvals, is mandatory for suppliers.

  • Prices fluctuate based on generator size, isotope activity, and regional market dynamics.


FAQs

1. How long does a technetium Tc-99m generator last?
Typically, 7 to 14 days, depending on the activity level and customer needs.

2. What are the main regional suppliers for North America?
Nordion (Thermo Fisher Scientific) supplies the US and Canada; GE Healthcare also operates globally.

3. How is the supply of Mo-99 affected by reactor outages?
Reactor outages disrupt Mo-99 production, causing periodic shortages and prompting shifts to alternative production methods.

4. Are there alternatives to Mo-99 based generators?
Yes, direct cyclotron production of technetium-99m offers a potential alternative, though not yet widely adopted.

5. What regulations govern the import of these generators?
In the US, the FDA regulates them; the EU uses EMA directives; other countries have respective national authorities, all requiring compliance with medical device standards.


References

[1] World Nuclear Association. (2022). "Molybdenum-99 & Technetium-99m."
[2] GE Healthcare. (2023). "Technetium Generators Product Information."
[3] European Medicines Agency. (2021). "Guidelines on radiopharmaceuticals."
[4] Nordion. (2022). "Mo-99/Tc-99m Generator Solutions."
[5] Ringtype Medical Co. Ltd. (2023). "UltraTech® Technetium Generators."

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