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Suppliers and packagers for OMNISCAN
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OMNISCAN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ge Healthcare | OMNISCAN | gadodiamide | INJECTABLE;INJECTION | 020123 | NDA | GE Healthcare Inc. | 0407-0690-10 | 10 VIAL in 1 BOX (0407-0690-10) / 10 mL in 1 VIAL | 2002-04-19 |
| Ge Healthcare | OMNISCAN | gadodiamide | INJECTABLE;INJECTION | 020123 | NDA | GE Healthcare Inc. | 0407-0690-15 | 10 VIAL in 1 BOX (0407-0690-15) / 15 mL in 1 VIAL | 2002-04-19 |
| Ge Healthcare | OMNISCAN | gadodiamide | INJECTABLE;INJECTION | 020123 | NDA | GE Healthcare Inc. | 0407-0690-20 | 10 VIAL in 1 BOX (0407-0690-20) / 20 mL in 1 VIAL | 2002-04-19 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: OMNISCAN
Introduction
OMNISCAN (indium111-pentreotide) is a radiopharmaceutical agent used primarily in diagnostic imaging, particularly for detecting neuroendocrine tumors and somatostatin receptor-positive lesions. As a specialized radiopharmaceutical, the supply chain for OMNISCAN involves a complex network of manufacturing companies, radiopharmacy centers, and global distribution channels. Understanding these suppliers’ roles, regulatory landscape, and market dynamics is crucial for stakeholders in healthcare, pharmaceutical procurement, and radiopharmaceutical logistics.
Overview of OMNISCAN Production
OMNISCAN is manufactured by focused radiopharmaceutical companies that specialize in the production of radioisotopes and targeted diagnostic agents. Its active component, indium-111-pentetreotide, is a radiolabeled somatostatin analog. The production process involves several critical steps, including synthesis of the peptide, radiolabeling with indium-111, and stringent quality control measures designed to meet regulatory standards such as those outlined by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
The complex and sensitive nature of radiopharmaceutical manufacturing makes suppliers highly specialized and regulated entities. The primary suppliers are typically associated with nuclear medicine centers, diagnostic radiopharmacy networks, and global pharmaceutical companies with nuclear medicine divisions.
Key Suppliers of OMNISCAN
1. Mallinckrodt Pharmaceuticals
Mallinckrodt, a global leader in nuclear medicine, has historically been among the primary suppliers of radiopharmaceuticals, including indium-111 labeled compounds. Their production facilities in the United States and Europe provide a reliable source of OMNISCAN or comparable somatostatin receptor imaging agents. Mallinckrodt’s expansive distribution network ensures accessibility in North America, Europe, and select Asian markets.
2. Curium Pharma
Curium Pharma specializes in innovative radiopharmaceuticals, including those used in neuroendocrine tumor imaging. They develop and distribute diagnostic agents like indium-111 pentetreotide for nuclear medicine applications. Curium's robust manufacturing facilities, combined with their global footprint, make it a significant supplier of OMNISCAN or similar agents, especially in Europe and Australia.
3. Lantheus Medical Imaging
Lantheus, a prominent player in diagnostic imaging agents, has expanded its portfolio to include radiopharmaceuticals for neuroendocrine tumors. Although primarily focused on agents like technetium-based compounds, Lantheus has invested in radiolabeling technologies that complement the use of indium-111 agents, potentially serving as a supplier or distributing partner for OMNISCAN in certain regions.
4. Nuclear Pharmacy Networks and Radiopharmacies
Large radiopharmacy networks such as Triad Isotopes (US), Cardiolite, and Iba Radiopharmacy operate regional centers that manufacture or dispense radiopharmaceuticals like OMNISCAN. These entities often source from primary manufacturers and provide localized distribution, ensuring timely access for nuclear medicine facilities.
5. Regulatory and Contract Manufacturing Organizations (CMOs)
In recent years, some pharmaceutical companies and research institutions have entered into licensing agreements with CMOs to produce indium-111-labeled somatostatin analogs. These arrangements serve to meet regional demand surges and to circumvent manufacturing bottlenecks.
6. Indium-111 Production Sources
Since the active component of OMNISCAN is indium-111, the supply chain also depends on isotope producers. Indium-111 is typically produced via neutron irradiation of enriched silver targets in nuclear reactors, with suppliers such as:
- IsoTera Medical (part of Eckert & Ziegler)
- PerkinElmer and other isotope producers supplying raw isotope material for radiolabeling processes.
Regulatory and Supply Chain Challenges
The production and distribution of OMNISCAN face significant hurdles, including:
- Regulatory approvals: Each supplier must meet strict CGMP standards, ensure safe handling, and obtain licenses for radiopharmaceutical manufacturing.
- Radioisotope availability: Indium-111's limited half-life (~2.8 days) necessitates rapid manufacturing and distribution, complicating supply chains.
- Regional restrictions: Licensing restrictions and regional regulatory differences influence supplier operations and supply reliability.
- Supply-demand volatility: Fluctuations in diagnosis needs and the limited number of manufacturing facilities can cause shortages.
Market Dynamics and Future Outlook
The market for OMNISCAN and similar neuroendocrine imaging agents is influenced by the rising prevalence of neuroendocrine tumors and advances in imaging technology. Several factors are shaping the supply landscape:
- Consolidation among suppliers: Major players like Mallinckrodt and Curium continue to expand their manufacturing capacities.
- Innovation in radiopharmaceuticals: Development of alternative agents, such as Ga-68 peptides, provides competition but also signifies ongoing investment in neuroendocrine diagnostics.
- Regional manufacturing hubs: Increased focus on local production in Europe, Asia, and North America aims to reduce reliance on a few sources and mitigate isotope shortages.
- Regulatory harmonization: Cross-recognition agreements may streamline approvals and enhance supply stability.
Conclusion
Suppliers of OMNISCAN are primarily distinguished by their specialization in radiopharmaceutical manufacturing, their regulatory compliance, and their geographic reach. Key industry players like Mallinckrodt, Curium Pharma, and radiopharmacy networks dominate supply channels, supported by indium-111 isotope producers. Challenges remain in scaling production, maintaining isotope supply, and navigating complex regulatory landscapes. As demand for neuroendocrine tumor imaging continues to grow, the role of these suppliers will become even more critical in ensuring global access to OMNISCAN.
Key Takeaways
- OMNISCAN’s supply chain involves specialized manufacturers, radiopharmacies, and isotope producers, with global reach mostly through companies like Mallinckrodt and Curium Pharma.
- The production process demands rigorous regulatory compliance, given the radiopharmaceutical's sensitive nature and short half-life.
- Isotope availability remains a bottleneck, emphasizing the importance of reliable indium-111 supply sources.
- Market consolidation and regional manufacturing initiatives aim to improve supply resilience amid increasing demand.
- Stakeholders should monitor regulatory developments and isotope supply dynamics to anticipate potential shortages.
FAQs
1. Who are the primary manufacturers of OMNISCAN?
Mallinckrodt Pharmaceuticals and Curium Pharma are the leading suppliers, leveraging their advanced manufacturing facilities and extensive distribution networks to supply OMNISCAN globally.
2. How is indium-111 sourced for OMNISCAN production?
Indium-111 is produced via neutron irradiation of enriched silver targets in nuclear reactors, with key suppliers including IsoTera Medical and PerkinElmer.
3. What regional factors influence OMNISCAN’s supply?
Regulatory approvals, regional licensing, and infrastructure for radiopharmacies impact availability, with some regions facing shortages due to limited local manufacturing or isotope supply constraints.
4. Are there alternative agents to OMNISCAN for neuroendocrine tumor imaging?
Yes, Ga-68 labeled somatostatin analogs offer alternative imaging options, though OMNISCAN remains a standard where specific radiolabeling and imaging setups are in place.
5. What are the future supply chain trends for radiopharmaceuticals like OMNISCAN?
Expect increased regional production, technological innovation in isotopes, and stronger regulatory harmonization to enhance supply stability and address growing demand.
Sources
[1] U.S. Food and Drug Administration (FDA) resources on radiopharmaceutical manufacturing.
[2] European Medicines Agency (EMA) guidelines on diagnostic radiopharmaceuticals.
[3] Market reports by GlobalData and IQVIA on neuroendocrine tumor imaging agents.
[4] Company websites and press releases from Mallinckrodt, Curium Pharma, and isotope producers.
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