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Suppliers and packagers for generic pharmaceutical drug: LUTETIUM LU 177 DOTATATE
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LUTETIUM LU 177 DOTATATE
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 | LUTATHERA | lutetium lu 177 dotatate | SOLUTION;INTRAVENOUS | 208700 | NDA | Advanced Accelerator Applications USA, Inc | 69488-003-01 | 1 VIAL in 1 PACKAGE (69488-003-01) / 20.5 mL in 1 VIAL | 2018-01-26 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Lutetium Lu 177 Dotatate
Introduction
Lutetium Lu 177 Dotatate (commonly known by its generic name, Lutetium-177 DOTATATE or Lutetium-177 DOTA-TATE) has revolutionized the treatment of neuroendocrine tumors (NETs). As a targeted radiopharmaceutical, it offers significant therapeutic advantages for patients with somatostatin receptor-positive tumors. Given its critical role in precision oncology, securing reliable and high-quality supply chains is vital for healthcare providers, pharmaceutical companies, and research institutions. This analysis explores key suppliers for Lutetium Lu 177 Dotatate, highlighting their capabilities, geographic presence, and regulatory standing.
Overview of Lutetium Lu 177 Dotatate
Lutetium Lu 177 Dotatate is a radiolabeled peptide that combines a somatostatin analog with radioactive lutetium-177. It binds to somatostatin receptor subtype 2 (SSTR2), prevalent on neuroendocrine tumor cells, delivering targeted radiotherapy. The drug is approved by agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), with its proprietary formulation often supplied as a ready-to-use injectable.
The production of Lutetium Lu 177 Dotatate involves complex radiochemical synthesis, requiring access to high-purity lutetium-177, peptide conjugation, and stringent radiopharmaceutical manufacturing facilities compliant with Good Manufacturing Practice (GMP). The supply chain must also ensure safe handling, transportation, and storage given its radioactive nature.
Key Suppliers and Manufacturers
1. Advanced Accelerator Applications (AAA) / Novartis
Overview:
Advanced Accelerator Applications, acquired by Novartis in 2018, is the primary manufacturer and commercial supplier of Lutetium Lu 177 Dotatate globally. AAA pioneered the development of Lutetium-177-based radiopharmaceuticals and holds pivotal manufacturing licenses.
Capabilities:
- Manufacturing Facility: Located in Millipore, France, equipped with state-of-the-art cyclotron and radiopharmaceutical synthesis units.
- Supply Chain: AAA maintains a robust, global distribution network, ensuring supply in North America, Europe, and select Asian markets.
- Regulatory Approvals: Approved by FDA (2020) under the brandname Lutathera, and by EMA for the European Union market, solidifying its dominant market position.
Supply Constraints:
- Limited production capacity due to complex manufacturing processes.
- Supply depends on availability of high-purity lutetium-177, often sourced from dedicated cyclotrons or nuclear reactors.
2. IRE Elit (Poland)
Overview:
IRE Elit operates as a major European supplier of radiopharmaceuticals, including lutetium-177. They manufacture both therapeutic and diagnostic radionuclides, serving hospitals and radiopharmacies across Europe.
Capabilities:
- Product Portfolio: Supplies lutetium-177 chloride, used in various radiopharmaceuticals, including externally compounded formulations for Lutetium Lu 177 Dotatate synthesis.
- Regulatory Status: CE-marked products compliant with European standards, with capacity to meet regional demand.
Limitations:
- Primarily supplies raw radioisotopes rather than finished pharmaceutical products, requiring downstream manufacturers to complete formulation and quality assurance.
3. Nordion / Canada’s Nordion (Aurora, Ontario)
Overview:
Historically a major supplier of medical radioisotopes, Nordion produces lutetium-177 via reactor method or accelerator routes.
Capabilities:
- Production Methods: Reactor-based neutron irradiation of ytterbium-176 to generate lutetium-177.
- Application: Provides raw lutetium-177, used by pharmaceutical manufacturers to produce different radiolabeled compounds.
Market Position:
- While Nordion doesn't supply Lutetium Lu 177 Dotatate directly, its isotopes are integral to the supply chain, particularly in North America.
4. IsoTPE GmbH
Overview:
German-based IsoTPE specializes in the synthesis of radiolabeled peptides and supports the availability of lutetium-177 for research and clinical use.
Capabilities:
- Custom synthesis and radiolabeling services for researchers and pharmaceutical companies.
- Supplies high-purity lutetium-177 for R&D and production validation.
Limitations:
- Not a large-scale commercial supplier of finished drugs but vital in early-stage development and proof-of-concept studies.
Emerging and Regional Suppliers
- Eckert & Ziegler (Germany): They offer isotope production services and radiopharmaceutical solutions but currently focus more on diagnostic isotopes.
- ITM Isotopen Technologies (Germany): Developing new sourcing options for therapeutic radionuclides, including lutetium-177, with an emphasis on supply reliability.
- China’s CNNC and China Isotope & Radiation Corporation: Growing regional players producing lutetium-177, although regulatory and quality standards may vary.
Supply Challenges and Quality Standards
The global supply chain for Lutetium Lu 177 Dotatate hinges on the availability of high-purity lutetium-177, a process constrained by reactor capacity, nuclear regulations, and international supply agreements. Ensuring consistent quality—compliance with pharmacopoeias (USP, EP, JP)—and adherence to GMP standards is paramount for suppliers.
Furthermore, the radioactive nature mandates specialized logistics networks, involving licensed carriers and secure transport protocols, which can limit rapid or widespread distribution.
Regulatory and Certification Considerations
Suppliers must possess relevant licenses from nuclear regulatory authorities, such as the U.S. Nuclear Regulatory Commission (NRC), European Atomic Energy Community (Euratom), or equivalent bodies. Certification in Good Manufacturing Practice (GMP) is essential for pharmaceutical-grade rivals aiming for broad commercialization.
Future Outlook and Supply Trends
- Increasing Demand: As neuroendocrine tumor treatment expands and new clinical trials emerge, the demand for Lutetium Lu 177 Dotatate will continue to grow, stressing supply chains.
- Manufacturing Expansion: Novartis and other key players are investing in capacity expansion, including new cyclotron facilities and improved nuclear reactor access, to meet rising needs.
- New Suppliers: Regional isotope production initiatives and emerging companies aim to reduce supply bottlenecks, improve pricing, and diversify sources.
Key Takeaways
- Primary Supplier: Novartis via AAA remains the dominant global supplier of Lutetium Lu 177 Dotatate, with extensive regulatory approvals and distribution infrastructure.
- Raw Material Suppliers: IRE Elit and Nordion are critical providers of lutetium-177 radioisotopes, supporting the manufacturing pipeline worldwide.
- Emerging Players: Regional and research-focused suppliers such as IsoTPE and China-based firms contribute to increasing supply resilience.
- Supply Chain Challenges: Capacity constraints, regulatory hurdles, and logistics complexities necessitate proactive sourcing strategies.
- Market Opportunities: The expanding therapeutic landscape underscores the importance of scalable, diversified supply chains to meet global demands.
FAQs
1. Who are the main global manufacturers of Lutetium Lu 177 Dotatate?
Advanced Accelerator Applications (owned by Novartis) is the primary manufacturer and supplier of the finished Lutetium Lu 177 Dotatate formulation globally, with manufacturing facilities in France.
2. How is lutetium-177 produced for pharmaceutical applications?
Lutetium-177 is typically produced via neutron irradiation of ytterbium-176 in nuclear reactors or through accelerator-based methods, followed by chemical separation to achieve high purity.
3. What regulatory standards must suppliers meet for medical-grade lutetium-177?
Suppliers must comply with GMP standards, possess nuclear regulatory licenses, and ensure proper quality control aligned with pharmacopeial standards (USP, EP, JP).
4. Are regional or local suppliers viable sources for Lutetium Lu 177 Dotatate?
Yes, regional suppliers like IRE Elit and emerging nuclear isotope producers can supply raw lutetium-177 isotopes or preliminary formulations, but completed drugs are primarily supplied by large, regulated manufacturers like Novartis.
5. What are the future trends affecting supply chains for Lutetium Lu 177 Dotatate?
Market growth, capacity expansion, technological advancements in isotope production, and regional manufacturing initiatives will continue to influence supply availability and pricing dynamics.
References
[1] Novartis. (2020). FDA Approval of Lutathera for Neuroendocrine Tumors.
[2] European Medicines Agency. (2021). EMA Marketing Authorization for Lutathera.
[3] IRE Elit. Product catalogs for lutetium-177 isotopes.
[4] Nordion. Radionuclide Production Report, 2022.
[5] ISO TPE. Custom radiochemistry services for research applications.
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