GALLIUM DOTATATE GA-68: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aaa Usa Inc	NETSPOT	gallium dotatate ga-68	POWDER;INTRAVENOUS	208547	NDA	Advanced Accelerator Applications USA, Inc	69488-001-40	1 KIT in 1 KIT (69488-001-40) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE	2016-06-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: April 21, 2025

Gallium-68 dotatate (Ga-68 dotatate) is a radiopharmaceutical agent critical for positron emission tomography (PET) imaging of somatostatin receptor-positive neuroendocrine tumors (NETs). Its supply chain involves a complex network of manufacturers, generator suppliers, distributors, and radiopharmacy networks. This report examines the key players, regulatory milestones, clinical adoption, and challenges in the Ga-68 dotatate supply chain, drawing insights from FDA approvals, distributor partnerships, and industry developments.

Manufacturers and Developers of Gallium-68 Dotatate

Advanced Accelerator Applications (AAA) and Novartis

Advanced Accelerator Applications (AAA), a subsidiary of Novartis since 2018, developed NETSPOT™ (gallium Ga-68 dotatate), the first FDA-approved Ga-68 radiopharmaceutical. NETSPOT™ received FDA approval in June 2016 following priority review and orphan drug designation, which facilitated its rapid commercialization[5][10]. The drug’s approval was based on clinical trials demonstrating its superiority in detecting NETs compared to existing imaging agents, with studies published in the Journal of Nuclear Medicine highlighting its diagnostic accuracy[5][10]. AAA’s strategy included partnerships with radiopharmacy networks to ensure nationwide distribution, leveraging Novartis’ global infrastructure post-acquisition[6][12].

Regulatory and Production Framework

The FDA approval mandated the use of specific germanium-68/gallium-68 (⁶⁸Ge/⁶⁸Ga) generators, such as the GalliaPharm® from Eckert & Ziegler, for preparing NETSPOT™ doses[3][10]. AAA’s production process involves a lyophilized kit (dotatate powder and buffer solution) reconstituted with Ga-68 eluted from these generators[2][3]. This approach ensures standardization, though it ties the drug’s availability to generator supply[11][13].

Distribution Networks and Radiopharmacy Partnerships

Cardinal Health’s Role as Primary Distributor

Cardinal Health, the largest radiopharmaceutical distributor in the U.S., serves as the exclusive distributor of the IRE ELiT Galli Eo® generator and several FDA-approved Ga-68 tracers, including NETSPOT™[1]. Its network of 116 nuclear pharmacies enables on-demand production and delivery, supported by integrated technologies like Nuctrac for real-time inventory management[1][7]. In 2016, Cardinal Health partnered with AAA to address initial supply bottlenecks, particularly in regions with high demand for NET imaging[6][12].

Expansion Through Triad Isotopes and NDP

To broaden access, AAA collaborated with Triad Isotopes (now part of Curium) and Nuclear Diagnostic Products (NDP) in 2016. Triad’s extensive radiopharmacy network and expertise in NET diagnostics complemented AAA’s goals, while NDP focused on personalized dose delivery in the Northeast[6]. These partnerships aimed to reduce wait times and ensure dose availability in metropolitan areas, though geographic disparities persisted[6][11].

⁶⁸Ge/⁶⁸Ga Generator Suppliers

Eckert & Ziegler’s GalliaPharm® Generator

The GalliaPharm® generator, approved for use with NETSPOT™, became the cornerstone of Ga-68 dotatate production. Each generator provides ⁶⁸Ga through elution with hydrochloric acid, yielding activities suitable for 200–400 patient doses over a 12-month lifespan[11][13]. However, its limited elution capacity (400 elutions/generator) and Eckert & Ziegler’s production delays led to shortages in 2018, affecting over 70% of U.S. imaging centers[11].

IRE ELiT Galli Eo® Generator

The IRE ELiT Galli Eo® generator, distributed exclusively by Cardinal Health, offers an alternative with comparable ⁶⁸Ga elution efficiency (75–87%) and low germanium breakthrough (<0.001%)[1][8]. Despite its reliability, regulatory hurdles delayed its FDA approval for NETSPOT™ preparation until 2020, exacerbating supply chain fragility during the GalliaPharm® shortage[11][13].

Clinical Adoption and Guidelines

Inclusion in NCCN and SNMMI Recommendations

NETSPOT™’s inclusion in the National Comprehensive Cancer Network (NCCN) guidelines in 2017 solidified its role in NET management. The guidelines endorse Ga-68 dotatate PET/CT for initial staging, recurrence detection, and treatment monitoring[12]. Similarly, the Society of Nuclear Medicine and Molecular Imaging (SNMMI) advocates its use, citing superior sensitivity over traditional indium-111 pentetreotide scans[11][12].

Hospital-Based Production via Automated Synthesis

Over 500 U.S. hospitals employ automated synthesis systems (e.g., Scintomics GRP®) for in-house Ga-68 dotatate preparation. These systems achieve radiochemical purity >98.5%, reduce radiation exposure, and comply with Good Manufacturing Practice (GMP) standards[4][8]. For example, a 2014 study reported an 87.9% synthesis yield using the Eckert & Ziegler generator, enabling reliable daily production[8][13].

Supply Chain Challenges and Mitigation Strategies

The 2018 Gallium-68 Shortage

In 2018, Eckert & Ziegler’s inability to meet GalliaPharm® demand prompted SNMMI to petition the FDA for interim solutions. Key issues included:

Generator lifespan constraints: The 400-elution limit forced pharmacies to ration doses[11].
Single-supplier dependency: No approved alternatives to GalliaPharm® existed until 2020[11][13].
Geographic disparities: Cities like Los Angeles and Chicago faced 3-week wait times for scans[11].

FDA Interventions and Future Directions

SNMMI proposed:

Temporary elution limit exemptions to extend generator use[11].
Approval of IRE ELiT generators via emergency authorization[11].
Cyclotron-produced Ga-68 chloride to bypass generator reliance[13].
The FDA’s 2020 approval of IRE ELiT generators and ongoing trials with cyclotron-based production (e.g., University of Iowa) aim to diversify supply sources[13][14].

Conclusion

The Ga-68 dotatate supply chain hinges on collaboration between manufacturers, generator suppliers, and radiopharmacies. While AAA/Cardinal Health partnerships and automated synthesis systems have improved access, vulnerabilities persist due to regulatory and production bottlenecks. Future strategies, including cyclotron integration and multi-generator approvals, are critical to meeting growing demand. As NET incidence rises, ensuring reliable Ga-68 dotatate supply will remain pivotal for precision oncology.

Key Takeaways

Primary Suppliers: AAA (Novartis) manufactures NETSPOT™; Cardinal Health and Triad Isotopes distribute it.
Generator Dependency: Eckert & Ziegler and IRE ELiT are key ⁶⁸Ge/⁶⁸Ga generator suppliers.
Supply Challenges: 2018 shortages highlighted risks of single-supplier reliance, prompting FDA interventions.
Clinical Impact: NCCN guidelines endorse Ga-68 dotatate for NET imaging, driving adoption.

FAQs

What is NETSPOT™?
NETSPOT™ is an FDA-approved kit for preparing Ga-68 dotatate, used in PET imaging of neuroendocrine tumors[2][10].
Why did Ga-68 dotatate face shortages in 2018?
Shortages arose from production delays in GalliaPharm® generators and regulatory limits on elutions[11].
How do hospitals produce Ga-68 dotatate?
Automated synthesis systems prepare doses using generators, achieving >98.5% purity[4][8].
What role does Cardinal Health play?
Cardinal Health distributes generators and coordinates dose production across 116 pharmacies[1][7].
Are there alternatives to GalliaPharm® generators?
Yes. The IRE ELiT Galli Eo® generator was approved in 2020, and cyclotron-produced Ga-68 is under study[13][14].

“The FDA approval of NETSPOT™ is a key milestone in improving NET diagnosis, reducing radiation exposure, and enhancing patient comfort.” – Stefano Buono, CEO of Advanced Accelerator Applications[10]

References

https://www.cardinalhealth.com/en/product-solutions/pharmaceutical-products/nuclear-medicine/radiopharmaceuticals/pet/gallium-68.html
http://www.radiopharmaceuticals.info/ga-68-dotatate.html
https://www.novartis.com/us-en/sites/novartis_us/files/netspot.pdf
https://pmc.ncbi.nlm.nih.gov/articles/PMC4937702/
https://appliedradiology.com/articles/fda-approves-first-gallium-68ga-dotatate-radiopharmaceutical-tracer-for-pet-imaging-of-neuroendocrine-tumors
https://www.biospace.com/advanced-accelerator-applications-expands-u-s-netspot-supply-chain-with-two-additional-radiopharmacy-networks
https://www.bidnetdirect.com/not-stated/solicitations/closed-bids/statewide/6525-Radiopharmaceutical-Supplies-NETSPOT-Gallium-68-Dotatate/2320686502
https://pubmed.ncbi.nlm.nih.gov/27408863/
https://go.drugbank.com/drugs/DB13925
https://www.globenewswire.com/news-release/2016/06/02/845561/0/en/Advanced-Accelerator-Applications-Announces-FDA-Approval-of-NETSPOT-Somakit-TATE-a-Kit-for-the-Preparation-of-Gallium-Ga-68-Dotatate-for-Neuroendocrine-Tumor-Detection.html
https://healthimaging.com/topics/healthcare-policy/snmmi-urges-fda-help-reduce-shortage-gallium-68
https://www.globenewswire.com/news-release/2017/03/01/929453/0/en/Advanced-Accelerator-Applications-Announces-Addition-of-NETSPOT-to-National-Comprehensive-Cancer-Network-Guidelines-for-Evaluation-of-NETs.html
https://www.liebertpub.com/doi/10.1089/cbr.2019.3301
https://pmc.ncbi.nlm.nih.gov/articles/PMC7151717/
https://www.drugs.com/ingredient/gallium-ga-68-dotatate.html

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