Suppliers and packagers for TECHNETIUM TC-99M PENTETATE KIT

TECHNETIUM TC-99M PENTETATE KIT

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Curium	TECHNETIUM TC-99M PENTETATE KIT	technetium tc-99m pentetate kit	INJECTABLE;INJECTION	215146	ANDA	Curium US LLC	69945-314-05	5 VIAL in 1 KIT (69945-314-05) / 10 mL in 1 VIAL (69945-314-01)	2025-04-08
Curium	TECHNETIUM TC-99M PENTETATE KIT	technetium tc-99m pentetate kit	INJECTABLE;INJECTION	215146	ANDA	Curium US LLC	69945-314-30	30 VIAL in 1 CARTON (69945-314-30) / 10 mL in 1 VIAL (69945-314-01)	2025-04-08

Suppliers for the Pharmaceutical Drug: TECHNETIUM TC-99M PENTETATE KIT

Last updated: July 28, 2025

Introduction

Technetium Tc-99m Pentetate Kit stands as a cornerstone in nuclear medicine imaging, primarily used for renal and cerebral scintigraphy. Its widespread clinical application hinges on reliable supply chains, strict regulatory compliance, and consistent manufacturing standards. For healthcare providers, radiopharmacies, and pharmaceutical distributors, sourcing authentic, high-quality kits is paramount to ensure patient safety and diagnostic accuracy. This article examines key suppliers globally, the landscape of manufacturing, and the strategic considerations critical for sourcing Technetium Tc-99m Pentetate Kits.

Overview of Technetium Tc-99m Pentetate Kits

Technetium Tc-99m Pentetate Kits facilitate the preparation of radiopharmaceuticals for diagnostic imaging. The kit contains a lyophilized mixture of pentetate (diethylenetriaminepentaacetic acid — DTPA) and other stabilizers, which, when reconstituted with Tc-99m from a generator, emit gamma radiation detectable via gamma cameras. [1] These kits are approved by regulatory agencies such as the FDA, EMA, and other national bodies, emphasizing strict quality control standards.

Major Global Suppliers of Tc-99m Pentetate Kits

1. GE Healthcare

   GE Healthcare is a prominent provider of radiopharmaceuticals, including the Techneplate™ or equivalent kits for Tc-99m DTPA compounds. Their longstanding presence in nuclear medicine, coupled with global distribution networks, assures access to reliable kits. GE's manufacturing standards adhere to Good Manufacturing Practices (GMP), ensuring high purity, sterility, and stability, vital for diagnostic accuracy.

2. Lantheus Medical Imaging

   Lantheus offers a suite of radioisotope and radiopharmaceutical products, with an emphasis on diagnostic imaging agents. They manufacture Tc-99m DTPA kits that are widely used across North America and Europe, with a focus on regulatory compliance and supply chain robustness.

3. Bracco Imaging

   As a leading international provider of diagnostic agents, Bracco supplies Technetium Tc-99m Pentetate Kits across numerous markets. Their collaborative approach with nuclear medicine centers ensures supply continuity and compliance with regional regulatory standards.

4. Rotem Industries

   An Israeli manufacturer, Rotem Industries produces radiopharmaceutical kits, including Tc-99m DTPA. Their offerings are distributed across Europe, Asia, and the Middle East, emphasizing cost-effectiveness and adherence to international quality criteria.

5. Nuclear Associates (Elekta)

   Though more regionally focused, Nuclear Associates supplies kits for Tc-99m labeling, including DTPA formulations suited for specific markets. Their focus on quality and stability supports diagnostic efficacy.

6. Regional and Local Suppliers

   Many countries have local manufacturers compliant with local regulatory bodies (e.g., the Indian Pharmacopoeia or China's National Medical Products Administration). These suppliers provide kits tailored to regional demand, often at competitive prices, though regulatory validation is critical in selecting such sources.

Emerging Trends and New Entrants

As the global supply of Mo-99 (the parent isotope of Tc-99m) faces challenges, suppliers are prioritizing diversification and local production of generators and kits. New entrants in the field often leverage advanced manufacturing technologies, aiming to reduce costs and improve shelf life and ease of use.

Regulatory Considerations

Suppliers must comply with regulatory requirements such as FDA approval, EU Good Manufacturing Practice (GMP), and regional standards. Verification of regulatory approval is essential when evaluating suppliers. Manufacturers also require batch-specific documentation, stability data, and validation reports.

Supply Chain Challenges

The proliferation of supply disruptions, including the 2019 global shortage of Mo-99, underscores the need for diversified sourcing strategies. Radiopharmacies and hospitals often rely on multiple suppliers to mitigate risks. Ultimately, the choice hinges on supplier reliability, product quality, logistical efficiency, and regional availability.

Strategic Considerations for Procurement

• Certification and Compliance: Ensure supplier holds requisite certifications (e.g., FDA, EMA, ISO 9001).

• Quality and Purity: Confirm product specifications align with pharmacopeial standards (USP, European Pharmacopoeia).

• Supply Capacity: Evaluate manufacturing capacity and logistical support.

• Cost Factors: Balance affordability with quality assurance.

• Regulatory Support: Assess the supplier’s ability to provide comprehensive documentation and support for regulatory inspections.

Conclusion

The procurement of Technetium Tc-99m Pentetate Kits requires meticulous evaluation of suppliers with proven manufacturing excellence and regulatory compliance. Leading global players like GE Healthcare, Lantheus, and Bracco provide a reliable foundation for nuclear medicine imaging. Emerging regional manufacturers expand options, especially amid supply chain challenges. Strategic sourcing, grounded in regulatory assurance and logistical reliability, remains central to supporting high-quality diagnostic services.

Key Takeaways

• Leading international suppliers such as GE Healthcare, Lantheus, and Bracco dominate the market for Tc-99m Pentetate Kits, offering proven quality and regulatory compliance.

• Regional manufacturers are increasingly important in diversifying supply and mitigating global shortages, especially in emerging markets.

• Ensuring adherence to GMP and pharmacopeial standards is critical for safe, effective diagnostic imaging agents.

• Supply chain resilience depends on multi-source procurement, regional manufacturing capacity, and detailed regulatory documentation.

• Ongoing monitoring of global isotope supply and technological innovations influence sourcing strategies and availability.

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FAQs

1. Are there regional differences in suppliers of Tc-99m Pentetate Kits?
Yes. While global players like GE Healthcare and Lantheus supply widely, regional manufacturers serve local markets, often offering cost-effective options. Regulatory approvals and regional certifications influence supplier selection.

2. How can healthcare providers ensure the authenticity and quality of Tc-99m Pentetate Kits?
Providers should verify suppliers' certifications (e.g., FDA, EMA, GMP compliance), review batch documentation, and adhere to validated storage and handling protocols to ensure product integrity.

3. What impact does the global Mo-99 shortage have on Tc-99m Pentetate Kit availability?
The shortage of Mo-99 reduces Tc-99m production, affecting all Tc-99m-based kits. Diversification of supply sources, local generator production, and alternative imaging agents are strategies to mitigate this impact.

4. Are there alternative radiopharmaceuticals to Tc-99m Pentetate Kits for renal imaging?
Yes. Alternatives include other Tc-99m labeled compounds, though Tc-99m DTPA remains a standard due to its favorable pharmacokinetics and imaging qualities.

5. What regulatory documents should I request when sourcing Tc-99m Pentetate Kits?
Request Certificates of Analysis (CoA), manufacturing licenses, stability data, GMP certificates, and any regional regulatory approvals to validate product suitability.

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References

[1] European Pharmacopoeia. Techneplate™ Tc-99m DTPA Kit Monograph. 2022.