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

GALLIUM GA-68 GOZETOTIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Telix Innovations	GOZELLIX	gallium ga-68 gozetotide	POWDER;INTRAVENOUS	219592	NDA	Telix Innovations SA	84552-500-25	1 KIT in 1 CARTON (84552-500-25) * 2.5 mL in 1 VIAL, MULTI-DOSE (84552-502-25) * 6.4 mL in 1 VIAL, MULTI-DOSE (84552-503-64) * 2 mL in 1 AMPULE (84552-504-25) * 1 POWDER, FOR SOLUTION in 1 VIAL, MULTI-DOSE (84552-501-25)	2025-03-20
Telix Innovations	GOZELLIX	gallium ga-68 gozetotide	POWDER;INTRAVENOUS	219592	NDA	Telix Innovations SA	84552-500-64	1 KIT in 1 CARTON (84552-500-64) * 2.5 mL in 1 VIAL, MULTI-DOSE (84552-502-25) * 6.4 mL in 1 VIAL, MULTI-DOSE (84552-503-64) * 2 mL in 1 AMPULE (84552-504-25) * 1 POWDER, FOR SOLUTION in 1 VIAL, MULTI-DOSE (84552-501-25)	2025-03-20
Telix	ILLUCCIX	gallium ga-68 gozetotide	POWDER;INTRAVENOUS	214032	NDA	Telix Pharmaceuticals (US) Inc.	74725-100-25	1 KIT in 1 CARTON (74725-100-25) * 2.5 mL in 1 VIAL, MULTI-DOSE (74725-102-25) * 6.4 mL in 1 VIAL, MULTI-DOSE (74725-103-64) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE (74725-101-25)	2021-12-17
Telix	ILLUCCIX	gallium ga-68 gozetotide	POWDER;INTRAVENOUS	214032	NDA	Telix Pharmaceuticals (US) Inc.	74725-100-64	1 KIT in 1 CARTON (74725-100-64) * 2.5 mL in 1 VIAL, MULTI-DOSE (74725-102-25) * 6.4 mL in 1 VIAL, MULTI-DOSE (74725-103-64) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE (74725-101-25)	2021-12-17

Gallium Ga-68 Gozetotide Suppliers

Last updated: February 19, 2026

This report identifies current and potential suppliers of Gallium Ga-68 Gozetotide, a radiopharmaceutical used in positron emission tomography (PET) imaging for prostate cancer detection. The analysis focuses on entities with established manufacturing capabilities, regulatory approvals, and the capacity for radiopharmaceutical production and distribution.

Who are the key manufacturers and suppliers of Gallium Ga-68 Gozetotide?

The supply chain for Gallium Ga-68 Gozetotide is complex, involving producers of the precursor molecule, radioisotope suppliers, and radiopharmacies that synthesize the final PET imaging agent.

Precursor Molecule Manufacturers

The precursor molecule for Gallium Ga-68 Gozetotide is NOTA-VMT, which is conjugated with DOTA-TATE. Companies specializing in peptide synthesis and radiopharmaceutical precursors are crucial in this stage.

• ABX GmbH: Located in Radeberg, Germany, ABX GmbH is a significant producer of radiopharmaceutical precursors and active pharmaceutical ingredients (APIs). They are known to supply NOTA- and DOTA-conjugated peptides used in Ga-68 radiopharmaceuticals.
• Peptide Sciences: This company, part of Thermo Fisher Scientific, offers custom peptide synthesis services and may produce relevant intermediates for Ga-68 labeling. Their capabilities include GMP-compliant synthesis for pharmaceutical applications.
• Other Custom Peptide Synthesis Companies: Numerous contract manufacturing organizations (CMOs) globally possess the expertise to synthesize complex peptides like NOTA-VMT. Companies such as Bachem and Intavis AG are examples of firms with peptide synthesis capabilities that could be leveraged.

Gallium-68 Radioisotope Suppliers

Gallium-68 (Ga-68) is a key radioisotope for this application. It is typically eluted from a Germanium-68/Gallium-68 (Ge-68/Ga-68) generator.

• Curium: Curium is a leading global supplier of radioisotopes for medical, industrial, and research applications. They produce Ge-68, the parent isotope for Ga-68 generators.
• ITM (Isotope Technologies Munich): ITM is a prominent supplier of medical radioisotopes, including Ge-68. They are a key provider of Ge-68/Ga-68 generators to the radiopharmaceutical market.
• Eckert & Ziegler: This company is involved in the supply of various isotopes and related products. They offer Ge-68/Ga-68 generators, essential for on-demand production of Ga-68 radiotracers.
• Nordion: As a global supplier of isotopes for medical imaging and therapy, Nordion is also a potential source for Ge-68/Ga-68 generators.

Radiopharmacies and Radiopharmaceutical Manufacturers

These entities are responsible for the final synthesis of Gallium Ga-68 Gozetotide by labeling the NOTA-VMT precursor with Ga-68 eluted from a generator. They operate under strict Good Manufacturing Practice (GMP) regulations.

• Radiopharmacies with GMP Facilities: A network of accredited radiopharmacies worldwide are capable of producing Ga-68 labeled tracers. These include academic medical centers and commercial radiopharmacies. Examples include:
  • Good Samaritan Hospital (Cincinnati, USA): Historically involved in the development and production of PET tracers.
  • University Hospitals (various locations): Many university hospitals with nuclear medicine departments have in-house radiopharmacies that produce custom radiotracers.
  • Commercial Radiopharmacies: Companies like Specialty Radiopharmacies and Cardinal Health operate networks of radiopharmacies that can produce and distribute PET agents, depending on regional licensing and manufacturing capabilities for specific compounds.
• Pharmaceutical Companies with Radiopharmaceutical Divisions: While many Ga-68 tracers are produced by smaller entities or in-house at imaging centers, larger pharmaceutical companies are increasingly entering the radiopharmaceutical space.
  • Advanced Accelerator Applications (AAA), a Novartis Company: AAA is a leading radioligand therapy and precision imaging company. They have a significant presence in the development and commercialization of theranostic agents, including Ga-68 based PET tracers. They are a primary commercial supplier for other Ga-68 tracers like Gallium Ga-68 DOTATATE.
  • Telix Pharmaceuticals: Telix is actively developing and commercializing radiopharmaceuticals for oncology. While their current focus may be on other isotopes or specific targets, their strategic expansion into Ga-68 labeling is a possibility.
  • GE Healthcare: GE Healthcare is a major player in medical imaging and diagnostics, including nuclear medicine. They have been involved in PET tracer development and distribution, and their portfolio includes radiochemicals and generators.

What is the regulatory landscape for Gallium Ga-68 Gozetotide production?

The production and distribution of Gallium Ga-68 Gozetotide are subject to stringent regulatory oversight to ensure safety, efficacy, and quality. Key regulatory bodies and requirements include:

• Food and Drug Administration (FDA) in the United States:

  • Investigational New Drug (IND) Application: For investigational use, an IND is required.
  • New Drug Application (NDA) or Biologics License Application (BLA): For commercial approval, a comprehensive application demonstrating safety and efficacy is necessary.
  • Current Good Manufacturing Practices (cGMP): Manufacturers must adhere to cGMP regulations (21 CFR Parts 210 and 211) for pharmaceutical production. This includes rigorous quality control and assurance.
  • Radiopharmaceutical Regulations: Specific regulations for radioactive drugs, such as 21 CFR Part 300, apply.

• European Medicines Agency (EMA) in Europe:

  • Marketing Authorisation Application (MAA): Equivalent to the NDA in the US, this is required for commercialization.
  • Good Manufacturing Practice (GMP) Compliance: Production facilities must comply with EU GMP guidelines (EudraLex Volume 4).
  • Radiopharmaceutical Specific Guidelines: EMA provides specific guidance for radiopharmaceuticals.

• Other National Regulatory Authorities: Agencies in other countries, such as Health Canada, the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, and Australia's Therapeutic Goods Administration (TGA), have similar requirements for drug approval and manufacturing.

• Radioisotope Generator Regulations: The Ge-68/Ga-68 generators themselves are subject to regulatory approval as medical devices or radiopharmaceutical precursors.

• Radiopharmacy Licensing: Radiopharmacies that synthesize the final product must be licensed by relevant national and state/provincial authorities, demonstrating compliance with radiation safety and drug compounding standards.

Key Regulatory Considerations:

• Quality of Precursors: The purity and quality of the NOTA-VMT precursor are critical for successful labeling and imaging. Suppliers must meet strict specifications.
• Radiochemical Purity: The final Gallium Ga-68 Gozetotide product must have a high radiochemical purity, meaning that the Ga-68 is predominantly bound to the target molecule and not as free Ga-68.
• Sterility and Pyrogenicity: As an injectable product, it must be sterile and free from pyrogens.
• Shelf-Life and Stability: The product's stability and usable shelf-life after synthesis are important logistical considerations. Ga-68 has a relatively short half-life (68 minutes), meaning production must be timely.

What are the challenges and opportunities in the Gallium Ga-68 Gozetotide supply chain?

Challenges

• Limited Availability of Gallium-68: While Ge-68/Ga-68 generators have improved availability, a significant surge in demand could strain current production capacities for Ge-68. The radioactive decay of Ge-68 limits its long-term storage and requires continuous production.
• Radiopharmacy Network Scalability: The need for on-site or local synthesis of Ga-68 tracers due to the short half-life of Ga-68 means that widespread adoption is dependent on the availability of qualified radiopharmacies with GMP facilities and skilled personnel. Building out this network is resource-intensive.
• Cost of Production: The synthesis of peptide precursors, the cost of Ge-68/Ga-68 generators, and the operational costs of GMP-compliant radiopharmacies contribute to the overall cost of Gallium Ga-68 Gozetotide.
• Cold Kit Manufacturing and Stability: The "cold kit" (the non-radioactive precursor and labeling reagents) must be stable and readily available. Manufacturers face challenges in ensuring long-term stability and consistent quality of these kits.
• Regulatory Hurdles for New Suppliers: Establishing a new manufacturing site or becoming a qualified supplier for a specific component (precursor, generator, or final product) requires significant investment in facilities, quality systems, and regulatory compliance, which can be time-consuming.
• Logistical Complexity: The short half-life of Ga-68 necessitates rapid delivery of the radiotracer from the point of synthesis to the patient. This requires efficient coordination between suppliers, radiopharmacies, and imaging centers.

Opportunities

• Increasing Demand for Prostate Cancer Imaging: The growing incidence of prostate cancer and the increasing use of PSMA-targeted PET imaging, for which Gallium Ga-68 Gozetotide is indicated, drives demand.
• Advancements in Generator Technology: Ongoing improvements in Ge-68/Ga-68 generator technology are enhancing efficiency and yield, potentially increasing the availability of Ga-68.
• Decentralized Production Models: The rise of smaller, more agile radiopharmacies and the development of automated synthesis modules for radiotracers offer opportunities for decentralized and on-demand production, addressing the half-life limitations.
• Theranostics Integration: Gallium Ga-68 Gozetotide is part of a broader trend towards theranostics. As theranostic agents (diagnostic and therapeutic counterparts) are developed, demand for their Ga-68 diagnostic components will likely increase.
• Emergence of New Suppliers: The lucrative nature of the radiopharmaceutical market is attracting new players, potentially increasing competition and driving innovation in supply chain efficiency and cost reduction.
• Technological Innovations in Peptide Synthesis: Advances in peptide synthesis technologies could lead to more efficient and cost-effective production of NOTA-VMT precursors.
• Contract Manufacturing Growth: The demand for specialized manufacturing services creates opportunities for contract manufacturing organizations (CMOs) to produce peptide precursors or components for radiopharmaceutical kits.

Key Takeaways

The supply of Gallium Ga-68 Gozetotide relies on a specialized network of precursor manufacturers, radioisotope providers, and GMP-compliant radiopharmacies. Key suppliers for the precursor molecule include ABX GmbH and custom peptide synthesis firms. Radioisotope supply is dominated by companies like Curium, ITM, and Eckert & Ziegler, who provide Ge-68/Ga-68 generators. Commercial entities such as Advanced Accelerator Applications (a Novartis company) are significant players in the radiopharmaceutical market for Ga-68 tracers. Regulatory compliance with FDA, EMA, and other national authorities is paramount, particularly concerning cGMP manufacturing and radiopharmaceutical handling. Challenges include scaling generator production and radiopharmacy networks, managing production costs, and overcoming logistical complexities due to Ga-68's short half-life. Opportunities lie in the growing demand for prostate cancer imaging, advancements in generator technology, decentralized production, and the expanding field of theranostics.

Frequently Asked Questions

1. What is the typical lead time for ordering Gallium Ga-68 Gozetotide from a radiopharmacy? Lead times are typically very short, often requiring orders to be placed within hours of the desired administration time due to the short half-life of Ga-68. This necessitates close coordination between the imaging center, the radiopharmacy, and the patient's schedule.

2. Can Gallium Ga-68 Gozetotide be stored for extended periods after synthesis? No, Gallium Ga-68 Gozetotide cannot be stored for extended periods. The radioisotope Gallium-68 has a half-life of approximately 68 minutes, meaning its radioactivity significantly diminishes over time. It is synthesized shortly before administration.

3. Are there alternative radioisotopes that can be used with the NOTA-VMT precursor? While Gallium-68 is the standard for this specific application due to its favorable PET characteristics and availability from generators, the NOTA chelator can also be used to label other radioisotopes. However, for the established Gozetotide imaging agent, Ga-68 is specified.

4. What are the primary quality control tests performed on Gallium Ga-68 Gozetotide before administration? Key quality control tests include radiochemical purity (to ensure Ga-68 is bound to the peptide), radionuclidic purity (to confirm the absence of other radioisotopes), pH, sterility, and endotoxin levels.

5. How do pharmaceutical companies secure supply of the NOTA-VMT precursor for their radiopharmaceutical production? Companies typically establish supply agreements with specialized peptide manufacturers that can produce the precursor under GMP conditions. These agreements ensure consistent quality, volume, and timely delivery.