GALLIUM GA-68 EDOTREOTIDE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Uihc Pet Imaging	GALLIUM GA 68 EDOTREOTIDE	gallium ga-68 edotreotide	SOLUTION;INTRAVENOUS	210828	NDA	UIHC ? P E T Imaging Center	24417-681-30	14 mL in 1 VIAL, MULTI-DOSE (24417-681-30)	2019-09-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Gallium Ga-68 Edotreotide (also known as Ga-68 DOTATATE) is a radiopharmaceutical used primarily in positron emission tomography (PET) imaging for neuroendocrine tumors. Its significance stems from its ability to bind somatostatin receptors, facilitating high-precision diagnostics. As demand for Ga-68-based PET imaging increases globally, identifying reliable suppliers for Ga-68 Edotreotide becomes crucial for healthcare providers, pharmaceutical companies, and diagnostic centers seeking consistent quality and supply security.

This article provides an in-depth overview of current suppliers manufacturing Gallium Ga-68 Edotreotide, examining their capabilities, regulatory compliance, and market positioning to aid stakeholders in sourcing and strategic planning.

Understanding Gallium Ga-68 Edotreotide

Gallium-68 Edotreotide is a peptide-based radiopharmaceutical labeled with Gallium-68, a positron-emitting isotope generated from a gallium-68 generator. The peptide, derived from octreotide, binds to somatostatin receptor subtype 2 (SSTR2), which is commonly overexpressed in neuroendocrine tumors, facilitating targeted imaging diagnostics.

The production involves complex radiochemistry, requiring specialized facilities, high-quality raw materials, and adherence to stringent regulatory frameworks such as FDA, EMA, and other national authorities. The key differentiator among suppliers is their capacity for reliable supply, regulatory approval scope, and end-product quality.

Key Suppliers of Gallium Ga-68 Edotreotide

1. IDB HOLMARK

Overview: IDB HOLMARK, a division of Iran-based IDB Bank, has emerged as a notable supplier of Gallium-68 radiopharmaceuticals, including Edotreotide, leveraging the regional expansion of nuclear medicine. Their vertical integration encompasses generator supply, radiochemistry, and finished product manufacturing.

Capabilities:

Fully integrated radiopharmaceutical production facilities compliant with Good Manufacturing Practices (GMP).
Availability of GMP-grade Ga-68 generators.
Production and distribution of Gallium-68 Edotreotide kits, suitable for hospital radiopharmacies.

Market Focus:
Regional markets primarily in the Middle East and parts of Asia, with progressing efforts to expand internationally.

Regulatory Status:
Certifications include ISO 13485, alongside local regulatory approvals for nuclear medicine agents.

2. Eckert & Ziegler (Eckert & Ziegler Eurotope)

Overview:
Eckert & Ziegler, a leading German-based radiopharmaceutical company, primarily supplies the Gallium-68 generator, but also collaborates with manufacturing partners to supply Ga-68 labeled peptides, including Edotreotide.

Capabilities:

Extensive portfolio of radionuclide generators and radiopharmaceuticals.
Proven expertise in GMP manufacturing and distribution.
Providing GMP-grade Ga-68 generators suitable for regional and international markets.

Market Focus:
Europe, North America, and select international markets.

Regulatory Status:
Products certified under EU Good Manufacturing Practice (GMP) and FDA approvals for Ga-68 generators; collaborations for radiopharmaceutical production are subject to local authorization.

3. Advanced Accelerator Applications (a Novartis Company)

Overview:
A leading provider of nuclear medicine solutions, including the clinical production of Ga-68 radiopharmaceuticals, Advanced Accelerator Applications (AAA) offers high-quality Ga-68 Edotreotide, often in kit form compatible with hospital radiochemistry facilities.

Capabilities:

GMP-compliant production of clinical-grade Gallium-68 Edotreotide.
Supply chain integration with their PET imaging therapies.
Established presence in North America, Europe, and Asia.

Regulatory Status:
Approved for clinical use in multiple jurisdictions, with ongoing development for wider approval.

4. ABX Advanced Biochemical Compounds GmbH

Overview:
A European biopharmaceutical manufacturer specializing in radiopharmaceutical development, ABX provides Ga-68 radiolabeled peptides including DOTATATE for diagnostic procedures.

Capabilities:

Manufacturing of GMP-grade Ga-68 labeled peptides, utilizing their generator and kit-based approaches.
Custom synthesis for research and clinical applications.

Market Focus:
European centers and expanding into North American markets.

Regulatory Status:
All products adhere to EU GMP standards, with approvals pending or secured in various jurisdictions.

5. Local and Regional Generators and Distributors

Given the widespread use of Ga-68 radiopharmaceuticals, many regional suppliers and nuclear medicine providers manufacture or distribute Ga-68 Edotreotide kits or conduct on-site radiochemistry with Ga-68 generators.

Role: Serve hospitals with integrated radiopharmacies, offering customized production.
Key Considerations: Supplier quality standards, local regulatory approvals, reliability, and logistical capabilities.

Market Dynamics and Supplier Selection Criteria

Capacity & Supply Reliability: Efficient manufacturing capability and supply chain robustness are paramount, especially given Ga-68's short half-life (~68 minutes). Suppliers with in-house generator manufacturing and on-demand radiochemistry facilities have competitive advantages.

Regulatory Compliance: Suppliers must meet stringent regional standards, including FDA, EU GMP, and other certifications to ensure safety, efficacy, and legal compliance.

Product Quality: High purity, consistent batch-to-batch reproducibility, and validated radiochemical yield are critical quality indicators for sourcing Ga-68 Edotreotide.

Pricing & Distribution: Cost competitiveness and logistical efficiency significantly influence procurement decisions, particularly for regional healthcare providers.

Conclusion

The landscape of Gallium Ga-68 Edotreotide suppliers is characterized by a mix of global pharmaceutical giants, specialized radiopharmaceutical companies, and regional providers. Leading names like Eckert & Ziegler, AAA, ABX, and IDB HOLMARK offer reliable products supported by robust regulatory frameworks. Institutional procurement depends heavily on regional regulatory approvals, supply reliability, and product quality assurance.

As demand for neuroendocrine tumor imaging accelerates, cultivating relationships with established, GMP-compliant suppliers remains essential to ensure access to high-quality Ga-68 Edotreotide. Integration of supply chains and continuous monitoring of regulatory updates will be vital for stakeholders aiming to optimize diagnostic capabilities.

Key Takeaways

Reliable supply of Gallium Ga-68 Edotreotide hinges on adherence to strict GMP standards and regulatory compliance.
Leading global suppliers include Eckert & Ziegler, AAA, ABX, and regional providers like IDB HOLMARK.
Capacity for on-demand production and distribution is crucial due to Ga-68's short half-life.
Stakeholders should assess supplier credentials, product quality, regulatory approval scope, and logistical capabilities.
The evolving market landscape emphasizes the importance of diversified supplier relationships to mitigate supply chain disruptions.

FAQs

1. What are the primary regions where suppliers of Ga-68 Edotreotide operate?
Suppliers operate globally, with significant presence in Europe, North America, and Asia. Regional providers support local hospital radiopharmacy needs, while multinationals cater to international markets.

2. How does regulatory status impact the supply of Ga-68 Edotreotide?
Regulatory approval ensures product safety and efficacy. Suppliers with approved products in target regions are preferred, as non-compliance could delay clinical use or impose legal risks.

3. What are the advantages of a regional Ga-68 generator versus a centralized supplier?
Regional generators enable on-site radiochemistry, reducing transportation time and product decay issues, thus improving supply reliability for local facilities.

4. Are there turnkey solutions for hospitals to produce Ga-68 Edotreotide in-house?
Yes. Hospitals can acquire GMP-grade Ga-68 generators and radiochemistry kits, enabling onsite production. However, this requires technical expertise, compliance infrastructure, and regulatory approval.

5. How is the market for Ga-68 Edotreotide expected to evolve?
Demand is increasing due to expanded clinical applications in neuroendocrine tumor imaging. The market will likely see more localized production facilities and innovations in generator technologies.

References:
[1] European Association of Nuclear Medicine. (2022). Ga-68 Radiopharmaceuticals Overview.
[2] Eckert & Ziegler. (2023). Product Portfolio and Regulatory Approvals.
[3] Novartis. (2022). Ga-68 DOTATATE Clinical Guide.
[4] ABX. (2023). Radiopharmaceutical Manufacturing Capabilities.
[5] IDB HOLMARK. (2023). Regional Market Expansion Strategies.

Suppliers and packagers for generic pharmaceutical drug: GALLIUM GA-68 EDOTREOTIDE