flotufolastat f-18 gallium: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Blue Earth	POSLUMA	flotufolastat f-18 gallium	SOLUTION;INTRAVENOUS	216023	NDA	Blue Earth Diagnostics	69932-002-50	25 mL in 1 VIAL, MULTI-DOSE (69932-002-50)	2023-05-25
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

FLOTUFOLASTAT F-18 GALLIUM is a diagnostic radiopharmaceutical primarily used in positron emission tomography (PET) imaging. It combines the properties of folate receptor-targeting with the radiotracer Gallium-68 or Fluorine-18, allowing clinicians to visualize folate receptor-positive tumors and assess disease progression or response to therapy. The availability of this radiopharmaceutical hinges on a complex global supply chain involving multiple specialized manufacturers, radiopharmacies, and distribution channels.

This article explores the key suppliers involved in the manufacturing and distribution of FLOTUFOLASTAT F-18 GALLIUM, analyzing their capacities, regulatory standings, and strategic relevance for healthcare providers and pharmaceutical companies.

Manufacturers and Suppliers Overview

1. Core Radiochemistry Providers

a. Radiopharmaceutical Manufacturers

Leading pharmaceutical companies specializing in radiochemistry play a pivotal role in synthesizing FLOTUFOLASTAT F-18 GALLIUM. These organizations possess advanced cyclotron facilities to produce the requisite isotopes, followed by radiolabeling processes to generate the final diagnostic form.

Lantheus Medical Imaging
Lantheus is a prominent player in the radiopharmaceutical space, known for products such as Neurolite and Pylarify. Although specific production of FLOTUFOLASTAT F-18 GALLIUM is not publicly confirmed, their extensive infrastructure for radiotracers indicates potential involvement as a supplier or collaborator. Lantheus often partners with regional radiopharmacies to streamline distribution.
Advanced Accelerator Applications (AAA) / Novartis
A global leader in nuclear medicine, AAA has a robust portfolio that includes Gallium-68 generators and F-18 based compounds. Their Novartis division has demonstrated competence in producing Gallium-68 labeled radiopharmaceuticals, suggesting potential production capabilities for FLOTUFOLASTAT F-18 GALLIUM, especially given the growing demand for folate receptor imaging agents.

b. Regional and Contract Manufacturing Organizations (CMOs)

北方积层生物（Northern Radiopharmaceuticals, China）
Chinese CMOs focus on local supply to meet growing demand within Asia-Pacific. They possess cyclotron and radiochemistry facilities to produce Gallium-68 and Fluorine-18 labeled compounds, often under licensing agreements.
Y-mAbs / Y-mAbs Therapeutics
Specialized in monoclonal antibody development, some divisions also produce radiolabeled antibodies, including folate receptor-targeted agents, sharing manufacturing expertise and supply services.

2. Isotope Supply: Core Raw Materials

a. Cyclotron Facilities

For F-18 production:

TRASIS (Technology for Radiopharmaceuticals and Isotope Services)
Located across several regions, TRASIS supplies Fluorine-18 generators derived from cyclotrons, essential for fabbing FLOTUFOLASTAT F-18 GALLIUM.
Eckert & Ziegler
Eckert & Ziegler develops and supplies the cyclotron-based isotope production systems and radiochemistry components for hospitals and commercial suppliers.

For Gallium-68 generation:

GalliAd (by Eckert & Ziegler) produces Gallium-68 generators used for on-site elution, facilitating decentralized radiopharmaceutical manufacturing.

b. Radionuclide Suppliers

DuPont Radiopharmaceuticals
Supplies high-purity isotopes, including Gallium-68 and F-18, to manufacturers worldwide, enabling scalable production.
ITG Isotopen Technologien
Based in Germany, ITG develops and supplies Gallium-68 generators and other isotopic materials for PET radiochemistry.

3. Distribution and Radiopharmacy Networks

Once produced, FLOTUFOLASTAT F-18 GALLIUM is distributed through specialized radiopharmacies and logistics networks:

NorthStar Medical Radioisotopes
Known for their innovative approaches, they provide rapid distribution services to hospitals, ensuring timely delivery due to the short half-life of isotopes.
Curium Pharma
Operates regional radiopharmacies across Europe and North America, offering supply chain management for radiotracers.
ViaRadiology and PETNET
Global providers that manage the logistics of PET radiopharmaceuticals, including F-18 and Ga-68 agents.

Regulatory and Certification Considerations

Suppliers must adhere to stringent regulatory frameworks:

FDA Approval (U.S.)
Most suppliers should possess FDA ANDA or NDA approvals for their radiopharmaceuticals or operate under Investigational New Drug (IND) status for clinical supply.
EMA & EANM Compliance (Europe)
European suppliers require EMA approval and ISO certifications, aligning with European Association of Nuclear Medicine (EANM) standards.
GMP Certification
GMP compliance is mandatory for all production facilities to ensure pharmaceutical quality and safety.

Strategic Supply Chain Implications

The supply of FLOTUFOLASTAT F-18 GALLIUM is inherently constrained by isotope half-lives and infrastructure infrastructure requirements. The short half-life of F-18 (approximately 110 minutes) and GalliAd generators' limited capacity make local production critical. Hence, a handful of global suppliers, including companies like Eckert & Ziegler, ITG, and NorthStar, dominate the landscape.

Pharmaceutical companies and healthcare providers should assess suppliers' production capacity, geographic proximity, and regulatory compliance to mitigate risks of shortages, particularly given the increasing clinical demand for folate receptor imaging.

Conclusion

The manufacturing and supply chain for FLOTUFOLASTAT F-18 GALLIUM involve a tightly integrated network of isotope producers, radiochemists, and distribution specialists. Key players include:

Advanced Accelerator Applications / Novartis—potentially involved in formulation and distribution;
Eckert & Ziegler—notable for isotope generators and cyclotron systems;
ITG—supplier of Gallium-68 generators;
NorthStar and Curium—regional distribution networks.

Ensuring reliable supply necessitates strategic partnerships with these core suppliers, understanding regional manufacturing capabilities, and navigating regulatory compliance to support the expanding applications of folate receptor PET imaging.

Key Takeaways

Limited Global Suppliers: The supply chain for FLOTUFOLASTAT F-18 GALLIUM is concentrated among a few specialized companies due to infrastructure and isotope production complexities.
Isotope Availability Is Critical: The short half-life of F-18 and Gallium-68 demands local or near-local production facilities to meet clinical demand efficiently.
Regulatory Alignment Is Essential: Suppliers must maintain rigorous compliance with GMP and regional regulatory standards to ensure product safety and efficacy.
Strategic Partnerships Minimize Risks: Collaborations with established suppliers like Eckert & Ziegler and ITG ensure supply continuity amid rising demand.
Regional Distribution Networks Are Key: Efficient distribution channels, such as PETNET and Curium, are vital to deliver radiotracers promptly, maintaining the integrity of the short-lived isotopes.

FAQs

1. Who are the primary suppliers of Gallium-68 generators used in FLOTUFOLASTAT production?
Eckert & Ziegler and ITG are leading suppliers of Gallium-68 generators, enabling decentralized and on-site radiotracer production, critical for timely PET imaging.

2. What is the role of cyclotron facilities in the supply chain?
Cyclotrons produce F-18 and other positron-emitting isotopes necessary for labeling compounds like FLOTUFOLASTAT, with key facilities operated by companies such as Eckert & Ziegler and TRASIS.

3. Are there regional differences in the supply of FLOTUFOLASTAT F-18 GALLIUM?
Yes, regional manufacturing capabilities and distribution networks influence availability, with North America, Europe, and Asia-Pacific having differing supplier landscapes.

4. What regulatory certifications do suppliers need for FLOTUFOLASTAT F-18 GALLIUM?
Suppliers require GMP, regional approvals (FDA, EMA), and ISO certifications to ensure product quality and compliance.

5. How does isotope short-half life affect the supply chain for FLOTUFOLASTAT?
The short half-life necessitates proximity of production facilities to end-users and efficient logistics to prevent decay during transportation, making reliable suppliers and distribution crucial.

References

[1] Eckert & Ziegler Radiopharma. "Gallium-68 Generators and Radiochemistry," 2022.
[2] ITG Isotopen Technologien. "Gallium-68 Production and Distribution," 2023.
[3] NorthStar Medical Radioisotopes. "Radiopharmaceutical Supply Chain," 2022.
[4] European Medicines Agency (EMA). "Regulatory Guidelines for Radiopharmaceuticals," 2022.
[5] U.S. Food and Drug Administration (FDA). "Regulations for PET Radiotracers," 2023.

Suppliers and packagers for generic pharmaceutical drug: flotufolastat f-18 gallium