Suppliers and packagers for netspot

netspot

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

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

Suppliers for the Pharmaceutical Drug: Netspot

Last updated: July 30, 2025

Introduction

Netspot is a radiotracer used in positron emission tomography (PET) imaging to detect neuroendocrine tumors. Its active ingredient, Gallium-68 (Ga-68) labeled DOTATATE, is a critical diagnostic tool in nuclear medicine, enabling precise visualization of somatostatin receptor-positive tumors. The global supply chain for Netspot hinges on a complex network of suppliers providing raw materials, radiopharmaceutical components, and manufacturing services. This article examines the primary suppliers involved in the production and distribution of Netspot, analyzing their roles, regulatory considerations, and market significance.

Manufacturers of Ga-68 Generators

At the core of Netspot production are the Ga-68 generators, which supply the radioactive isotope necessary for labeling DOTATATE. These generators are crucial, as they determine the availability and scalability of Netspot worldwide.

1. Eichrom Industries (PerkinElmer) Eichrom Industries, acquired by PerkinElmer, is a leading supplier of Ga-68 generators. Their GalliAd™ and GalliPharm™ generators are widely used in clinical settings for producing high-purity Ga-68 radioisotope. These generators utilize Germanium-68/Gallium-68 decay pairs, providing reliable and consistent isotope supply. They cater to hospitals and radiopharmacies globally, ensuring on-demand production of Netspot.

2. IDB Technologies IDB Technologies offers GalliaPharm™ generators, emphasizing compact design, ease of operation, and high elution yields. These generators are prominent in European markets, supported by their compliance with European pharmacopoeia standards. Their supply chain is pivotal for regional Netspot manufacturing.

3. Eckert & Ziegler (EZAG) EZAG provides the Gallquick™ generators, which are valued for their automation capabilities and high radioisotope purity. EZAG's global distribution network enhances the reach of Ga-68 radionuclide supply, indirectly supporting Netspot production.

Manufacturers of Radiopharmaceutical Components

The synthesis of Netspot involves critical components beyond the Ga-68 generator, mainly the DOTATATE peptide and necessary excipients.

1. Advanced Accelerator Applications (AAA) / Novartis AAA, now a Novartis subsidiary, produces high-quality DOTATATE peptides used in Netspot formulation. Their manufacturing facilities ensure batch-to-batch consistency, GMP compliance, and regulatory adherence across international markets.

**2. ABX Advanced Biomedical ABX supplies reagents and kits that facilitate the conjugation of Ga-68 to DOTATATE. Their products are integral in radiopharmacy labs and support flexible, in-house Netspot synthesis, especially in regions lacking centralized production facilities.

Manufacturers of Raw Materials and Nuclear Facility Components

Due to strict regulatory standards, raw materials and components used in rental, disposal, or manufacturing of Ga-68 generators and radiolabeling kits are supplied by specialized firms.

1. IoD (Institute of Nuclear and Radiological Sciences, Greece) IoD provides essential raw materials like germanium-68 for initial seed production and other radiochemical reagents.

2. Nuclear Reactor Suppliers Since Ga-68 is produced via generator systems rather than direct nuclear reactors, suppliers of medical-grade Ge-68 from medical isotope production facilities play a vital role. These supply agreements are often long-term and critically regulated.

Distribution and Logistics Suppliers

Efficient distribution networks for radiopharmaceuticals like Netspot are vital due to the isotope's short half-life (~68 minutes for Ga-68). Leading logistics providers include:

• Curatum — Specializes in cold chain logistics for radiopharmaceuticals.
• Global Radiopharmacies — Operate regional centers ensuring timely delivery to hospitals.
• Carrier and courier companies with specialized permits for radioactive materials, such as FedEx Custom Critical, DHL Medical Express, and UPS Healthcare.

Regulatory and Quality Assurance Suppliers

Suppliers providing sterilization, GMP validation, and quality control reagents are integral for the production of compliant Netspot batches:

• Cliniqa (part of Cardinal Health) — Supplies sterile filtration and sterilization products.
• Miltenyi Biotec — Provides cell separation and purification reagents for quality control processes.

Market Dynamics and Geographical Considerations

The distribution of suppliers often correlates with regional regulatory frameworks and market demand. The United States, Europe, and Asia dominate Netspot utilization, with supply chains evolving to meet increasing clinical adoption.

U.S. Market In the U.S., Novartis directly controls many aspects of Netspot’s supply chain, including licensing and sourcing components through collaborations with suppliers like Eichrom. The FDA’s regulatory oversight ensures strict supplier qualification.

European Market European manufacturers rely heavily on regional generators like IDB and Eckert & Ziegler, with suppliers adhering to the European Pharmacopoeia standards. Local regulatory agencies facilitate rapid market access, which influences supplier partnerships.

Asian Market Growing demand, especially in Japan and China, prompts regional suppliers to develop localized production facilities. Collaborations with local nuclear medicine networks are increasingly common, affecting global supplier dynamics.

Regulatory Challenges and Future Trends

Global supply chains for Netspot face challenges including regulatory compliance, logistical complexities, and geopolitical factors. Recent trends point toward:

• In-house Generator Production: Hospitals investing in in-house Ga-68 generator systems to ensure supply security.
• European & US Manufacturing Boosts: Expanding manufacturing capacities by major suppliers to meet increasing demand.
• Alternative Isotope Development: Investments in alternative radiotracers and later-generation generators that might supplement or replace Ga-68-based diagnostics.

Key Takeaways

• The primary suppliers of Ga-68 generators—such as Eichrom Industries, IDB Technologies, and Eckert & Ziegler—are central to Netspot’s supply chain.
• High-quality peptides from Novartis/AAA are crucial for the final radiopharmaceutical product.
• Logistics providers specializing in radiopharmaceutical transportation ensure timely distribution, crucial due to the short half-life of Ga-68.
• Regulatory standards significantly influence supplier operations, especially across different regional markets.
• The industry trends toward localized production and alternative isotope development could reshape the supply landscape in coming years.

FAQs

1. Who are the leading suppliers of Ga-68 generators used in Netspot production?
Eichrom Industries (PerkinElmer), IDB Technologies, and Eckert & Ziegler are the dominant global suppliers of Ga-68 generators, each providing reliable, high-quality isotopes for radiopharmaceutical manufacturing.

2. How does regional regulation impact Netspot supplier choices?
Regulatory requirements such as GMP compliance, pharmacopoeia standards, and licensing vary across regions, influencing procurement decisions and supplier partnerships for hospitals and radiopharmacies.

3. Are there alternative sources for Ga-68 besides generators?
Currently, Ga-68 is produced primarily via germanium-68/gallium-68 generators. Research into cyclotron-produced Ga-68 and alternative isotopes is underway but not yet widely commercialized.

4. What role do logistics providers play in the Netspot supply chain?
Logistics companies specializing in cold chain management and radioactive materials—like FedEx Custom Critical—ensure the timely, safe delivery of short-lived radiopharmaceuticals from production sites to clinical centers.

5. Will the supply chain for Netspot evolve in the near future?
Yes. Trends include increased in-house generator use, expansion of manufacturing capacities, regional production, and exploration of alternative isotopes, all aiming to bolster supply resilience amid rising demand.

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References
[1] PerkinElmer. “GalliAd and GalliPharm Ga-68 Generators,” 2022.
[2] Eckert & Ziegler. “Gallquick™ Ga-68 Generators,” 2022.
[3] Novartis. “_ADVANCED Radiopharmaceuticals for Neuroendocrine Tumor Imaging,” 2022.
[4] European Pharmacopoeia. “Ga-68 Generators and Radiopharmaceutical Standards,” 2022.
[5] U.S. Food and Drug Administration. “Regulatory Framework for Radiopharmaceuticals,” 2022.