Suppliers and packagers for LYMPHOSEEK KIT

LYMPHOSEEK 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
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

Suppliers for the Pharmaceutical Drug: LYMPHOSEEK KIT

Last updated: August 1, 2025

Introduction

The LYMPHOSEEK KIT, also known by its generic name, technetium Tc-99m tilmanocept, is a diagnostic radiopharmaceutical used primarily in the localization of lymph nodes for in vivo imaging, especially in breast cancer and melanoma. As a key tool in nuclear medicine, its availability hinges on a complex supply chain involving active pharmaceutical ingredients (API), radiolabeling materials, advanced manufacturing facilities, and distributors. Ensuring an understanding of current suppliers is crucial for healthcare professionals, hospital procurement teams, and pharmaceutical companies aiming to maintain consistent access to this vital diagnostic agent.

Manufacturers and Primary Suppliers

1. Navidea Biopharmaceuticals, Inc.

Navidea Biopharmaceuticals is the original developer of the LYMPHOSEEK KIT, with extensive involvement in its R&D, manufacturing, and commercialization. The company holds the patent rights for tilmanocept-based radiopharmaceuticals and manufactures the kit under its proprietary protocols. Their facilities across the U.S. meet stringent cGMP standards, and the company coordinates closely with national regulatory agencies to ensure compliance and supply continuity.

Key Points:

• Manufacturing Location: United States, primarily at Navidea's FDA-approved facilities.
• Supply Capacity: Limited but focused on meeting regional and international demand, with ongoing expansions to increase global distribution.

2. Radiopharmaceutical Contract Manufacturers

While Navidea directly supplies the LYMPHOSEEK KIT in the majority of cases, third-party contract manufacturing organizations (CMOs) play an auxiliary role in scaling production and ensuring supply resilience. These CMOs specialize in radiopharmaceutical manufacturing, leveraging expertise in handling radionuclides like Tc-99m, which has a short half-life (~6 hours).

Examples Include:

• Eckert & Ziegler: A prominent radiopharmaceutical producer with capability to scale up production of Tc-99m labeled agents under contract manufacturing agreements.
• JSC "DALKAR" (Russia): A notable producer of technetium generators, crucial for the radiolabeling process.

3. Radiochemistry Suppliers and Radiolabeling Material Providers

The kit relies on high-purity isotopes of technetium-99m sourced from molybdenum-99 generators supplied by dedicated isotope producers. Suppliers involved include:

• NorthStar Medical Radioisotopes: Supplies Mo-99/Tc-99m generators to radiopharmacies.
• NTP Radioisotopes (South Africa): Major global supplier of Mo-99.
• PerkinElmer: Provides radiochemistry reagents and kits for radiolabeling processes.

These suppliers are crucial collaborators, ensuring the raw materials for the kit are available with consistent quality.

Distribution and Logistics

Given the perishable nature of Tc-99m, logistics providers specializing in cold chain and radiopharmaceutical transport are integral to the supply network. Major logistics vendors include:

• Schering Plough (now part of Merck): Has historically played a role in distribution within North America.
• Lantheus Medical Imaging: Distributes diagnostical radiopharmaceuticals, including related agents.
• Local radiopharmacies and nuclear medicine departments: Often source the LYMPHOSEEK KIT via regional distributors or directly from Navidea or licensed centralized radiopharmacies.

Regulatory and Market Dynamics

FDA approval (U.S.) and CE marking (Europe) influence supplier operations. Navidea's license maintains its sole production rights in many markets, but international licensing and distribution agreements may involve third-party suppliers or regional manufacturers under strict compliance standards.

Global demand for the LYMPHOSEEK KIT influences the number and capacity of suppliers. The radionuclide's supply chain depends on nuclear reactors producing molybdenum-99, which shapes the stability and availability of the entire product.

Emerging Suppliers and Future Outlook

The supply chain for radiopharmaceuticals faces ongoing challenges, including reactor shutdowns, supply disruptions, and geopolitical tensions. In response, efforts are underway to develop alternative production methods for Tc-99m (e.g., cyclotron-based production) and to diversify the supplier base.

Innovations include:

• High-yield cyclotron production of Tc-99m, reducing reliance on aging reactors.
• Partnerships with emerging radiopharmaceutical manufacturers in Asia and Europe.
• Regulatory pathways for generic or biosimilar versions to increase market competition and supply resilience.

Conclusion

The supply of LYMPHOSEEK KIT is primarily controlled by Navidea Biopharmaceuticals, supported by a network of radiochemistry suppliers, contract manufacturers, and logistics providers. Ensuring robust supply channels remains essential given the critical role of this agent in cancer staging and surgical planning. As the global nuclear medicine landscape evolves, diversification of suppliers and novel production methods are likely to enhance supply security and affordability.

---

Key Takeaways

• Navidea Biopharmaceuticals is the primary global supplier of LYMPHOSEEK KIT, with manufacturing facilities in the U.S.
• Supplier network encompasses radiochemistry providers, Mo-99 isotope producers, and logistics firms, integral to a safe and reliable supply chain.
• Global nuclear reactor capacity and geopolitical factors directly impact Tc-99m availability, influencing the supply of the kit.
• Emerging production methods like cyclotron-based Tc-99m aim to reduce dependency on traditional reactor-produced isotopes, promising future supply stability.
• Regulatory approvals and licensing agreements significantly influence the geographic reach and operational capacity of suppliers.

---

FAQs

Q1. Who are the main suppliers manufacturing LYMPHOSEEK KIT?
Primarily, Navidea Biopharmaceuticals manufactures and supplies the LYMPHOSEEK KIT. They are supported by radiopharmacy network partners, radiochemistry providers, and Mo-99 isotope suppliers globally.

Q2. How does the supply chain of Tc-99m influence the availability of LYMPHOSEEK KIT?
Tc-99m's short half-life necessitates reliable, immediate supply from Mo-99 generators. Disruptions in reactor operations or transporter issues can cause shortages, directly affecting LYMPHOSEEK KIT availability.

Q3. Are there regional variations in suppliers for the LYMPHOSEEK KIT?
Yes. While Navidea distributes mainly in North America, Europe, and selected international markets under licensing agreements, other regions may rely on local radiopharmacies or regional manufacturers with licensed or generic alternatives.

Q4. Are there plans to develop non-reactor-based sources of Tc-99m to support LYMPHOSEEK KIT?
Yes. Research centers and industry stakeholders are investing in cyclotron-based production methods, which could eventually supplement or replace reactor-based Mo-99, enhancing supply security.

Q5. How do regulatory approvals affect the supply of LYMPHOSEEK KIT?
Regulatory approvals, such as FDA clearance and CE marking, are prerequisites for commercialization. They influence manufacturing obligations, licensing, and distribution rights, thereby impacting availability in various markets.

---

Sources

[1] Navidea Biopharmaceuticals Official Website. "Lymphoseek: Product Information."
[2] World Nuclear Association. "The Supply Chain of Medical Isotopes."
[3] U.S. Food and Drug Administration. "Lymphoseek (technetium Tc-99m tilmanocept) Injection, for intravenous use."
[4] OECD-NEA. "Medical Isotope Supply Chain and Future Perspectives."
[5] PerkinElmer. "Radiochemistry Reagents and Kits."