TECHNETIUM TC-99M SUCCIMER: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Theragnostics	NEPHROSCAN	technetium tc-99m succimer	POWDER;INTRAVENOUS	214993	NDA	Theragnostics Inc	71083-0020-5	5 VIAL, SINGLE-DOSE in 1 CARTON (71083-0020-5) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71083-0020-1)	2022-02-18
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 5, 2025

Introduction

Technetium-99m (Tc-99m) succimer is a radiopharmaceutical agent used primarily in diagnostic imaging to evaluate kidney function and detect renal tumors. As a radiolabeled compound, its production involves specific supplier networks capable of manufacturing both the radioactive component (Tc-99m) and the active pharmaceutical ingredient (API: succimer). Given the complex regulatory landscape and stringent quality standards, suppliers operate globally, predominantly within regions of advanced nuclear medicine traditions, such as North America, Europe, and Asia.

This analysis provides a comprehensive overview of the leading suppliers of Tc-99m succimer, focusing on their manufacturing capabilities, regulatory compliance, market presence, and strategic positioning to assist stakeholders in procurement, strategic planning, and market assessment.

Manufacturers of Key Components

1. Generators for Technetium-99m (Tc-99m)

Tc-99m is derived from molybdenum-99 (Mo-99) generators, which are central to radiopharmaceutical supply networks.

Lantheus Medical Imaging (United States): One of the largest suppliers offering Mo-99 generators, which produce Tc-99m used in various radiopharmaceuticals, including succimer.
Curium Pharma (UK/Europe): Provides a range of Mo-99 generators, emphasizing high-quality and regulatory compliance.
Rosenergoatom (Rusatom Service) (Russia): Operates Mo-99 production facilities for regional distribution in Eastern Europe and Asia.
NTP (National Tsing Hua University, Taiwan): Has developed alternative production methods for Mo-99, expanding supply security.

2. Suppliers of Pre-Formed Tc-99m Kits

Tc-99m succimer is supplied as a ready-to-use kit that, upon reconstitution with eluted Tc-99m, yields the diagnostic agent.

Mallinckrodt Pharmaceuticals (Ireland/USA): A significant producer of radiopharmaceutical kits, including Tc-99m succimer, with extensive regulatory approvals worldwide.
Bracco Imaging (Italy): Provides various radiopharmaceutical kits, including succimer, supplying diverse markets.
Polatom (Poland): Offers European-approved kits, with a growing recognition in Central Europe.
Isotope Products Laboratories (IPL) (USA): Supplies a portfolio of radiopharmaceutical kits, including Tc-99m succimer, catering to North American markets.

Direct Suppliers of Tc-99m Succimer

While most suppliers source Tc-99m via generators and prepare the kits in-house, some pharmaceutical companies or radiopharmacies produce and distribute finished Tc-99m succimer for clinical use.

Notable Suppliers Include:

GE Healthcare (Now part of Cytiva): Historically provided Tc-99m kits, including succimer, although recent restructuring has shifted focus.
Click Chemistry (India): Emerging regional supplier offering radiopharmaceuticals, including Tc-99m succimer, often targeting the Asian markets.
Radiopharmaceuticals of Australia (RoA): Known for localized production of Tc-99m compounds in the Oceania region.
Regional nuclear medicine centers and radiopharmacies: Due to the short half-life of Tc-99m (6 hours), many hospitals and clinics produce their own succimer from generator eluates, effectively acting as secondary suppliers.

Key Factors Influencing Supplier Selection

Regulatory approval and licensing: Suppliers must hold licenses from agencies such as the U.S. FDA, EMA (European Medicines Agency), or national regulatory bodies in their respective regions.
Quality assurance (QA) and Good Manufacturing Practice (GMP): Only manufacturers compliant with GMP standards ensure safety, efficacy, and consistency of Tc-99m succimer.
Supply chain reliability: Given the short half-life of Tc-99m, timely delivery and regional proximity are critical.
Production capacity: To meet global demand, suppliers invest in scalable infrastructure and alternative production methods, such as reactor-based Mo-99 production or cyclotron methods.

Market Dynamics and Key Players

Regional Market Presence

North America remains the most mature market, with dominant suppliers such as Lantheus Medical Imaging and nuclear pharmacies producing vast quantities of Tc-99m succimer.
Europe benefits from multiple regional suppliers, including Polatom and Bracco, and a well-established regulatory environment.
Asia-Pacific is garnering importance through regional manufacturers like NTP (Taiwan), Fusion Pharma (India), and emerging radiopharmaceutical companies that target increasing diagnostic needs.

Supply Chain Trends

Supply security concerns stemming from the aging reactor-based Mo-99 infrastructure have prompted investments into alternative production methods, including accelerator-based techniques.
The global shortage of Mo-99 during certain periods has driven the proliferation of local generator production and regional supplier diversification.

Challenges and Opportunities

Regulatory hurdles and approval delays can limit market access for new suppliers.
The short half-life of Tc-99m necessitates highly synchronized logistics, favoring regional or local production.
Innovations in alternative isotopes (e.g., Tc-99m analogs with longer half-lives or different imaging modalities) could impact future demand for Tc-99m succimer.
Growing demand for personalized medicine and advanced diagnostic imaging sustains the need for reliable supplier networks.

Conclusion

The landscape of suppliers for Tc-99m succimer is characterized by a complex network of generator manufacturers, kit producers, radiopharmaceutical companies, and regional nuclear medicine centers. Major players like Lantheus, Polatom, and Bracco dominate through extensive regulatory approvals, high manufacturing standards, and wide geographic coverage. Suppliers leveraging innovative production methods and regional manufacturing hubs are well-positioned to address supply chain vulnerabilities.

Stakeholders should prioritize suppliers with proven regulatory compliance, robust logistics, and scalable production capabilities to ensure uninterrupted access to Tc-99m succimer, recognizing the intrinsic challenges posed by its short half-life and the critical role it plays in diagnostic nuclear medicine.

Key Takeaways

Leading suppliers include Lantheus, Polatom, Bracco, and regional manufacturers, each with strategic advantages based on geographic location, regulatory status, and production capacity.
Partnerships with generator providers and radiopharmaceutical kit manufacturers are essential components of a reliable supply chain.
Innovation in alternative production techniques may influence future market dynamics and supply security.
Due to the short half-life, regional and localized production remains vital for timely availability.
Regulatory compliance remains a critical factor in supplier qualification and risk mitigation.

Frequently Asked Questions

1. Who are the top global suppliers of Tc-99m succimer?
Lantheus Medical Imaging, Polatom, and Bracco Imaging are among the top suppliers, providing kits and generator services with extensive regulatory approvals worldwide.

2. How does the short half-life of Tc-99m impact its supply chain?
Its 6-hour half-life necessitates prompt distribution and often regional or local production, limiting reliance on distant suppliers and emphasizing the importance of timely logistics.

3. Are there alternative suppliers in emerging markets?
Yes. Companies in India, Taiwan, and Eastern Europe are developing regional production capabilities, leveraging innovations such as cyclotron-based Mo-99 production.

4. What role do radiopharmacies play in the supply of Tc-99m succimer?
Radiopharmacies often produce Tc-99m radiopharmaceuticals from generators, serving as secondary suppliers—particularly crucial in regions with limited commercial kit availability.

5. What are the key regulatory considerations for suppliers?
Suppliers must obtain approvals from agencies like the FDA, EMA, and regional regulators, ensuring GMP compliance, consistent quality, and safety standards.

Sources
[1] World Nuclear Association. "Technetium-99m: Production and Supply." 2022.
[2] Lantheus Medical Imaging. "Radiopharmaceuticals Portfolio." 2023.
[3] Polatom. "Radiopharmaceuticals Manufacturing and Supply Chain." 2022.
[4] European Medicines Agency (EMA). "Guidelines on the Quality, Supply Chain, and Regulation of Radiopharmaceuticals." 2021.

Suppliers and packagers for generic pharmaceutical drug: TECHNETIUM TC-99M SUCCIMER