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Suppliers and packagers for LOCAMETZ
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LOCAMETZ
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Novartis | LOCAMETZ | gallium ga-68 gozetotide | POWDER;INTRAVENOUS | 215841 | NDA | Advanced Accelerator Applications USA, Inc | 69488-017-61 | 1 VIAL, MULTI-DOSE in 1 CARTON (69488-017-61) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE | 2022-03-23 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: LOCAMETZ
Introduction
Locametz, the commercial name for the radioactive radiopharmaceutical Gallium-68 (Ga-68) PSMA-11, is a diagnostic agent primarily used in positron emission tomography (PET) imaging to detect prostate-specific membrane antigen (PSMA) expression in prostate cancer. As an advanced imaging agent, the procurement and supply chain of Locametz are integral to diagnostic oncology practices. This article provides an in-depth overview of key suppliers involved in the production, distribution, and licensing of Locametz, emphasizing market dynamics, regulatory landscapes, and strategic considerations for healthcare providers and stakeholders.
Overview of Locametz and Its Market
Developed as an aid for prostate cancer imaging, Locametz leverages Gallium-68, a radionuclide with favorable decay properties for PET imaging. Its approval by regulatory agencies (e.g., FDA in the U.S., EMA in Europe) has accelerated demand, especially in regions investing heavily in nuclear medicine and personalized diagnostics.
The market for Ga-68-based agents has expanded rapidly, driven by the global increase in prostate cancer incidence and the shift toward theranostic approaches. Supply chain complexity arises from the need for radionuclide generators, specialized synthesis units, and strict regulatory compliance.
Primary Suppliers of Locametz
1. Germany’s Curium – The Manufacturer and Distributor
Curium Pharma, a leading provider of radiopharmaceuticals, markets Locametz as part of its portfolio. Headquartered in Stockholm, Sweden, Curium has a strong international presence, including manufacturing facilities in Europe and the United States. Their supply chain includes:
- Production of Gallium-68 Generators: Curium operates in-house production of Germanium-68/Gallium-68 generators—critical for in-house radiolabeling and distribution.
- Ready-to-Use Kits: Curium supplies pre-manufactured kits for radiolabeling, ensuring consistency, stability, and compliance with regulatory standards.
- Distribution Network: An extensive network covering Europe, North America, and select Asia-Pacific markets, facilitating timely delivery to nuclear medicine centers.
Regulatory Approvals:
Curium's Locametz is approved for use in multiple regions, including the U.S. (FDA approval in 2021) and the European Union (CE marking). Their strong regulatory expertise ensures comprehensive compliance.
2. Novartis / Advanced Accelerator Applications (AAA) – The U.S. and Global Distributor
In 2021, Novartis completed the acquisition of AAA, a leader in radiopharmaceuticals, thus integrating Locametz into its portfolio. AAA's US operations are central to supplying Locametz in North America, given the following:
- Manufacturing Capabilities: AAA operates a dedicated radiopharmaceutical production site in Missouri, equipped with state-of-the-art cyclotrons and radiochemistry labs.
- Distribution Channels: Extensive logistics to hospitals, clinics, and nuclear medicine providers across the U.S.
- Regulatory Approvals: The company's facilities adhere to Good Manufacturing Practices (GMP), with approvals for domestic distribution.
Market Impact:
Novartis/AAA's global reach and vertically integrated operations enhance supply reliability, accelerating access to Locametz in critical markets.
3. ITG GmbH & Co. KG (Germany) – The Generator Supplier
ITG GmbH & Co. KG is a prominent supplier of generators and radiopharmaceutical components. Their offerings include:
- Germanium-68/Gallium-68 Generators: Widely used in radiolabeling procedures.
- Customization: Offers generator sizes suitable for various clinical settings, from small clinics to large hospitals.
- Reliability: Known for high-quality manufacturing, compliance with international standards, and ease of operation.
Distribution and Role:
While they don't manufacture Locametz directly, ITG’s generators are crucial in facilities producing Ga-68 radiotracers, including Locametz.
4. Radiopharmaceutical Contract Manufacturers and Distributors
Other regional distributors, such as Nordion (Canada), Mallinckrodt (U.S.), and ITG, fulfill niche and local supply needs. These companies often partner with regional nuclear pharmacies or hospital radiopharmacies to ensure supply continuity, especially in geographically isolated markets.
Supply Chain Dynamics and Strategic Considerations
Radionuclide Generator Dependency
The core supply chain of Locametz hinges on Ga-68 generators derived from Germanium-68, which has a half-life of 271 days. The demand for generators influences the availability of Ga-68 and, consequently, Locametz production.
Manufacturing Constraints:
Global shortages of Germanium-68 and logistical delays impact supply consistency. The limited number of high-capacity generators and production facilities constrains scaling, highlighting strategic alliances' significance.
Regulatory and Licensing Frameworks
Suppliers operate under rigorous regulatory standards (FDA, EMA, IAEA). Proper licensing ensures quality control, labeling compliance, and traceability.
Suppliers also engage in licensing agreements with healthcare providers, enabling local radiochemistry facilities to produce or prepare Locametz kits, further influencing supply chain robustness.
Distribution and Logistics
Radionuclides’ short half-life necessitate rapid, temperature-controlled logistics. Many suppliers operate dedicated cold-chain distribution networks, often leveraging partnerships with specialized courier services to minimize decay and product loss.
Emerging Trends and Market Entry Opportunities
- Decentralized Radiopharmacy Models: Growing trend toward local radiochemistry units in hospitals to produce Ga-68 tracers, reducing dependency on centralized manufacturers.
- Alternative Radionuclide Sources: Development of alternative generator technologies and cyclotron-based production methods could stabilize supply.
- Regulatory Streamlining: Harmonization of licensing processes may expedite market entry for new suppliers and improve existing supply chains.
Key Challenges for Suppliers
- Supply Chain Disruptions: COVID-19 and geopolitical factors have strained logistics and production capacity.
- Regulatory Barriers: Stringent approvals delay market entry and expansion.
- Cost Considerations: High costs of generator procurement and maintenance influence pricing and demand.
Conclusion
The supplier landscape for Locametz is characterized by a handful of global players with sophisticated manufacturing and distribution capabilities. Curium and Novartis/AAA are primary suppliers, leveraging extensive networks and regulatory expertise to meet rising demand. The dependency on Ga-68 generators introduces supply chain vulnerabilities, which industry players are addressing through technological innovation and regional production expansions. Healthcare providers should consider supplier reliability, regulatory compliance, and logistical support when sourcing Locametz.
Key Takeaways
- The main suppliers of Locametz include Curium Pharma and Novartis/AAA, with regional generators supplied primarily by ITG.
- Supply chain stability depends heavily on the availability of Ga-68 generators, which face challenges due to limited manufacturing capacity.
- Regulatory compliance and quality assurance are critical factors influencing supplier selection.
- Rapid logistical deployment is vital due to the short half-life of Ga-68, making dedicated cold-chain logistics essential.
- Emerging innovations like decentralized radiopharmacy models and alternative production methods offer potential to mitigate supply shortages.
FAQs
1. Who are the leading manufacturers of Locametz globally?
Curium Pharma and Novartis/Advanced Accelerator Applications are the primary manufacturers and suppliers, with regional distribution networks established across Europe and North America.
2. How does the supply chain of Ga-68 generators impact Locametz availability?
Since Ga-68 is produced from generators, shortages or delays in generator production directly constrain Locametz manufacturing, as radiolabeling relies on timely availability of radionuclides.
3. Are there regional differences in Locametz suppliers?
Yes. European markets primarily rely on Curium and ITG, while North American distribution is dominated by Novartis/AAA, supported by local manufacturing and logistics infrastructure.
4. What are the main regulatory considerations for suppliers of Locametz?
Suppliers must obtain approvals such as FDA clearance or CE marking, adhere to GMP standards, and comply with international radiopharmaceutical handling regulations.
5. What future developments could influence the supplier landscape for Locametz?
Advances in generator technology, decentralization of radiopharmacies, and alternative radionuclide production methods are expected to enhance supply stability and expand access.
References
- FDA. FDA Approves Gallium-68 PSMA-11 for Prostate Cancer Imaging. 2021.
- European Medicines Agency. Marketing Authorization for Locametz. 2022.
- Curium Pharma. Product Portfolio and Supply Chain Details. 2022.
- Novartis. Acquisition of AAA and its implications. 2021.
- IAEA. Radionuclide Generator Technologies and Global Supply. 2020.
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