technetium tc-99m tilmanocept: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cardinal Health 414	LYMPHOSEEK KIT	technetium tc-99m tilmanocept	INJECTABLE;INJECTION	202207	NDA	Cardinal Health 414, LLC	65857-425-05	1 KIT in 1 CARTON (65857-425-05) / 1 KIT in 1 KIT * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65857-400-01)	2017-09-20
Cardinal Health 414	LYMPHOSEEK KIT	technetium tc-99m tilmanocept	INJECTABLE;INJECTION	202207	NDA	Cardinal Health 414, LLC	65857-450-05	1 KIT in 1 CARTON (65857-450-05) / 1 KIT in 1 KIT * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65857-400-01) * 1 INJECTION, SOLUTION in 1 VIAL (65857-401-45)	2017-09-20
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Introduction

Technetium-99m (Tc-99m) Tilmanocept is a radiopharmaceutical agent widely used in diagnostic imaging, especially for sentinel lymph node biopsy procedures across oncology and infectious disease management. Its unique receptor-targeting properties allow precise localization of lymph nodes, making it invaluable in cancer staging. Given the critical role of suppliers in ensuring reliable access to this medical agent, identifying leading sources and understanding their market dynamics is vital for healthcare providers, distributors, and regulatory bodies aiming to secure supply security and optimize procurement strategies.

Overview of Technetium-99m Tilmanocept

Temporarily classified as a CD206 receptor ligand, Tc-99m Tilmanocept comprises a mannose-based backbone labeled with technetium-99m. Its rapid clearance from non-target tissues and high affinity for macrophages in lymphatic tissue confer high contrast for imaging. The drug's patent exclusivity and manufacturing complexity influence the supply chain, which is dominated by specialized radiopharmaceutical companies with expertise in lyophilized kits and radiolabeling processes [1].

Key Suppliers in the Market

1. Lantheus Medical Imaging

Role & Capabilities:
Lantheus is a leading producer and distributor of radiopharmaceuticals in the U.S. and globally. The company markets Lymphoseek (Tilmanocept), which essentially is Tc-99m Tilmanocept, under its proprietary brand. Lantheus has full manufacturing rights, including the lyophilized kit necessary for radiolabeling with Tc-99m. Their integrated supply chain ensures a consistent and high-quality product for imaging facilities.

Market Position & Distribution:
Lantheus's extensive network ensures access across North America, Europe, and parts of Asia. Its established partnerships with nuclear medicine centers and hospitals make it a dominant supplier for Tc-99m Tilmanocept. The firm's emphasis on scalable manufacturing and quality assurance aligns with regulatory standards, notably FDA approval in the U.S. [2].

2. GE Healthcare / Jubilant Radiopharma

Partnerships & Production:
While GE Healthcare pioneered many radiopharmaceutical imaging agents, its direct involvement with Tc-99m Tilmanocept revolves around licensing agreements and strategic partnerships. Jubilant Radiopharma, a prominent radiopharmaceutical manufacturer in India and expanding globally, has secured licensing rights for Tilmanocept manufacturing and distribution in certain markets, leveraging GE’s platforms in radiopharmaceutical production.

Supply Chain & Capabilities:
Jubilant develops and supplies radiolabeled kits tailored for local and international markets, ensuring timely delivery of Tc-99m Tilmanocept kits, especially in South Asia and Europe. They focus on localizing production to bypass import restrictions related to radionuclides and complex logistics involving Tc-99m generators [3].

3. Specialized Radiopharmaceutical Manufacturing Entities

Emerging & Niche Suppliers:
Beyond the dominant producers, several smaller companies and contract manufacturing organizations (CMOs) focus on custom radiolabeling services for medical imaging agents. These entities, often operating under regulatory licenses in Europe, North America, and Asia, serve as backup suppliers, particularly during shortages or increased demand.

Examples Include:

Curium Pharma (now part of IBA Group) has manufacturing capabilities for a range of radiopharmaceuticals, including Tc-99m products, and can potentially produce Tilmanocept under contractual agreements.
NDC (National Diagnostics Corporation), which supplies radiopharmaceutical kits, may undertake fill-finish services for Tilmanocept formulations, under licensing agreements with patent holders.

4. Regional and Local Suppliers

In many regions, local radiopharmacies and nuclear medicine centers assemble radiolabeled agents using certified kits and on-site generators of Tc-99m. These centers may source kit components or pre-manufactured drugs from international suppliers to meet regional demands and regulatory adaptations.

Supply Chain Considerations:
The complexity of Tc-99m's short half-life (6 hours) necessitates on-demand radiolabeling facilities and quick logistics, which influence regional sourcing strategies. Suppliers with local manufacturing capabilities tend to mitigate logistical constraints, especially in remote or resource-constrained settings.

Market Challenges and Supply Continuity

Despite the presence of multiple suppliers, market challenges impact the supply of Tc-99m Tilmanocept:

Radionuclide Supply Constraints: Tc-99m is derived from molybdenum-99 generators, whose global production is concentrated among a limited number of suppliers, such as NorthStar Medical Technologies and Curium. Disruptions in these supplies can cascade into shortages of labeled agents like Tilmanocept [4].
Regulatory and Patent Protections: Patent protections held by Lantheus or licensing agreements with other firms limit the entry of generic or alternative production, constraining market competition.
Manufacturing Complexity: The radiolabeling process, quality standards, and sterile manufacturing environments restrict the number of qualified suppliers capable of producing high-and consistent-quality Tilmanocept.

Future Outlook and Strategic Considerations

To mitigate supply risks, stakeholders are increasingly calling for diversification of the radiopharmaceutical supply chain. Advances in generator technology, alternative production methods for Tc-99m, and development of non-technetium-based receptor-targeting agents could influence the market landscape.

International collaborations aiming to expand manufacturing capacities, especially in emerging markets, will likely enhance supply resilience. Additionally, regulatory pathways enabling broader approval of generic equivalents or biosimilars could foster greater competition and lower prices, benefitting healthcare systems.

Key Takeaways

Lantheus Medical Imaging is the primary supplier of Tc-99m Tilmanocept globally, leveraging its established manufacturing and distribution channels under the brand Lymphoseek.
Jubilant Radiopharma and other regional manufacturers play critical roles in extending supply reach, notably in Asia and Europe.
The supply chain heavily depends on a limited number of molybdenum-99 producers and complex radiolabeling facilities, making it vulnerable to disruptions.
Regulatory exclusivity and patent protections limit market entry, emphasizing the need for strategic sourcing and diversification.
Future market growth hinges on innovations in radionuclide production, alternative supply models, and expanding manufacturing capacity.

FAQs

1. Who are the main global suppliers of Technetium-99m Tilmanocept?
Lantheus Medical Imaging is the primary supplier, offering the marketed product Lymphoseek. Regional manufacturers like Jubilant Radiopharma and other licensed producers supply Tilmanocept kits in various markets.

2. How does the supply chain for Tc-99m Tilmanocept work?
The supply involves molybdenum-99 production, distribution of Tc-99m generators, and radiolabeling kits filled and sterilized in specialized facilities. The final product is then distributed to nuclear medicine centers for on-site radiolabeling and imaging.

3. What are the market barriers affecting the supply of Tc-99m Tilmanocept?
Limited molybdenum-99 production capacity, patent protections limiting generics, manufacturing complexities, and logistic challenges of short-lived radioisotopes pose barriers.

4. Are there any new entrants or alternative suppliers emerging?
While some regional players and CMOs provide backup sources, widespread entry of new suppliers is constrained by regulatory and technical challenges. Advances in generator technology and alternative imaging agents are potential future disruptors.

5. How can healthcare providers ensure a stable supply of Tc-99m Tilmanocept?
By establishing relationships with multiple licensed suppliers, participating in inventory planning that accounts for radionuclide supply cycles, and engaging in strategic procurement initiatives, providers can enhance supply stability.

Sources

[1] Lantheus Medical Imaging. Lymphoseek [Online]. Available: https://www.lantheus.com/products/lymphoseek/
[2] U.S. Food and Drug Administration. FDA approval documents for Lymphoseek.
[3] Jubilant Radiopharma. Company Overview and Market Engagements [Online].
[4] World Nuclear Association. Molybdenum-99 and Technetium-99m Supply Chain.

Suppliers and packagers for generic pharmaceutical drug: technetium tc-99m tilmanocept