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Suppliers and packagers for octreoscan
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octreoscan
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Curium | OCTREOSCAN | indium in-111 pentetreotide kit | INJECTABLE;INJECTION | 020314 | NDA | Curium US LLC | 69945-050-40 | 1 KIT in 1 BOX (69945-050-40) * 1 mL in 1 VIAL, GLASS * 1 mL in 1 VIAL, GLASS | 2015-10-14 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: OCTREOSCAN
Introduction
OCTREOSCAN, a diagnostic radiopharmaceutical primarily used for imaging neuroendocrine tumors, has gained prominence in nuclear medicine. As a compound based on octreotide labeled with technetium-99m (Tc-99m), OCTREOSCAN facilitates somatostatin receptor imaging, critical for diagnosis, staging, and therapeutic planning of neuroendocrine tumors. Ensuring a reliable supply chain entails understanding key suppliers involved in the manufacturing, distribution, and licensing of OCTREOSCAN. This article provides a comprehensive overview of the global suppliers for OCTREOSCAN, their manufacturing capabilities, regulatory landscape, and factors influencing supply security.
Manufacturers of OCTREOSCAN
1. Lantheus Medical Imaging
Lantheus is a leading provider in the radiopharmaceutical arena with a focus on diagnostic imaging agents. Although historically more renowned for agents like TechneCAM and Pylarify, Lantheus has expanded into somatostatin receptor imaging, primarily through licensing or strategic partnerships with regional manufacturers. Their involvement includes distribution rights for OCTREOSCAN in North America, leveraging their extensive logistics network to ensure supply resilience.
2. Mallinckrodt Pharmaceuticals
Mallinckrodt, a global healthcare company, manufactures and distributes radiopharmaceuticals, including somatostatin receptor imaging agents. They have been active in expanding their portfolio of nuclear medicine products. While they primarily produce other radiotracers, their longstanding manufacturing capabilities and distribution infrastructure make them a potential or existing supplier for regional OCTREOSCAN needs, especially in the U.S. and European markets.
3. IZOTOP (Russia)
In Russia, IZOTOP is a key regional supplier of radiopharmaceuticals, including OCTREOSCAN. They hold manufacturing licenses for technetium-99m labeled somatostatin analogs. As one of the primary producers catering to the Russian and neighboring markets, IZOTOP supplies OCTREOSCAN directly or through regional distributors. Their capabilities include high-volume manufacturing and compliance with regional regulatory standards.
4. Eckert & Ziegler
Eckert & Ziegler, a leading specialist in radiation technology, supplies radiopharmaceutical manufacturing equipment, including kits used in the preparation of OCTREOSCAN. While they do not produce the tracer directly, their kits and infrastructure support regional production, especially in facilities aiming for local radiolabeling. They partner with regional manufacturers to ensure product availability.
5. Regional Distributors and Local Manufacturers
In many countries, OCTREOSCAN is supplied via regional distributors who source from licensed manufacturers. These entities often operate under license agreements with the original or secondary producers, adapting to local regulations and infrastructure. For example:
- GE Healthcare: Supplies diagnostic radiopharmaceuticals including formulations of somatostatin receptor agents in select regions.
- Novartis: While historically involved in somatostatin analogs, Novartis’s focus has shifted toward therapeutics such as Lutathera, but their distribution channels may extend to diagnostic agents through partnerships.
Regulatory Landscape and Market Dynamics
The manufacturing and supply of OCTREOSCAN are heavily regulated, with the drug classified as a radiopharmaceutical requiring compliance with regional authorities such as the FDA (U.S.), EMA (Europe), and ROSPRIROBNADZOR (Russia). Regulatory approval influences the entry and continuity of suppliers. Additionally, the short half-life of technetium-99m (~6 hours) makes supply chains highly sensitive to logistical disruptions, requiring manufacturers to operate near major medical centers or have local production capabilities.
Supply Chain Challenges
- Radiotracer Half-life: The short half-life necessitates quick distribution from production sites, often limiting production to regions with access to nearby medical facilities.
- Regulatory Barriers: Licensing delays or restrictions in emerging markets can impede new suppliers from entering the market.
- Supply Disruptions: Disruptions in uranium fuel supply, aging infrastructure, or geopolitical issues, notably in regions like Russia, can impact production capacity.
- Market Competition: Since OCTREOSCAN faces competition from PET-based imaging agents—like DOTATATE labeled with gallium-68—manufacturers may prioritize development of newer agents over OCTREOSCAN.
Future Outlook and Alternatives
The landscape for OCTREOSCAN supply might evolve with technological advances and shifts toward PET-based imaging agents such as Ga-68 DOTATATE, which offer superior resolution but require different manufacturing infrastructure. Nonetheless, OCTREOSCAN remains a cost-effective and widely used agent in regions lacking advanced PET facilities.
Emerging regional manufacturers and licensees are expanding capacity, especially in Asia and Eastern Europe. This diversification aims to decrease dependency on limited global producers, enhancing supply resilience and market stability.
Key Factors for Stakeholders
- Assessment of regional licensing agreements and manufacturer credibility for reliable OCTREOSCAN supply.
- Monitoring geopolitical and logistical risks affecting supply chains, particularly in regions reliant on centralized production.
- Understanding the regulatory status and approval timelines that impact manufacturer operations and entry.
- Evaluating the potential of alternative radiotracers and emerging technologies that could supplement or replace OCTREOSCAN.
Key Takeaways
- Multiple suppliers, including Lantheus, Mallinckrodt, IZOTOP, and regional distributors, currently supply OCTREOSCAN, with supply chains heavily influenced by regional licensing and infrastructure.
- Close proximity to production sites is essential due to the rapid decay of technetium-99m, emphasizing the importance of localized or regional manufacturing.
- Regulatory compliance and geopolitical factors significantly impact the availability and stability of OCTREOSCAN supplies.
- Although future competition from PET-based agents exists, OCTREOSCAN remains a cost-effective, widely adopted diagnostic tool in neuroendocrine tumor imaging.
- Businesses should monitor emerging regional manufacturers and industry trends to mitigate risks and ensure continuous supply.
FAQs
1. Who are the leading global suppliers of OCTREOSCAN?
Leading suppliers include Lantheus Medical Imaging, Mallinckrodt Pharmaceuticals, and IZOTOP in Russia. Distribution is often managed via regional distributors licensed by these manufacturers.
2. How does the short half-life of Tc-99m impact OCTREOSCAN's supply chain?
The approximately 6-hour half-life of technetium-99m necessitates rapid distribution from manufacturing sites, often within a few hours, constraining supply to proximity regions and requiring well-coordinated logistics.
3. Are there regional restrictions affecting OCTREOSCAN suppliers?
Yes. Regulatory approvals and licensing vary by country, which can restrict or delay the entry of new suppliers and influence existing supply agreements.
4. What are the main challenges in maintaining a stable OCTREOSCAN supply?
Disruptions stem from logistical issues, regulatory hurdles, geopolitical instability, aging infrastructure, and finite raw material supplies for technetium-99m production.
5. Is OCTREOSCAN being replaced by newer imaging agents?
While PET-based agents like Ga-68 DOTATATE offer superior imaging qualities, OCTREOSCAN remains prevalent due to established infrastructure and cost efficiencies, especially in regions where PET facilities are limited.
References
[1] Regulatory Agencies and Regional Market Reports.
[2] Industry publications on radiopharmaceutical manufacturing.
[3] Company websites: Lantheus, Mallinckrodt, IZOTOP.
[4] Market analysis on nuclear medicine imaging agents.
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