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Suppliers and packagers for generic pharmaceutical drug: INDIUM IN-111 PENTETATE DISODIUM
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INDIUM IN-111 PENTETATE DISODIUM
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 | MPI INDIUM DTPA IN 111 | indium in-111 pentetate disodium | INJECTABLE;INTRATHECAL | 017707 | NDA | Medi-Physics, Inc. dba GE Healthcare | 17156-251-08 | 1.5 mL in 1 VIAL, GLASS (17156-251-08) | 1982-02-18 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Indium-111 Pentetate Disodium
Introduction
Indium-111 Pentetate Disodium (In-111 Pentetate) is a radiopharmaceutical agent primarily used in diagnostic imaging, notably for scintigraphy, to evaluate organ and tissue morphology, detect infections, and assess specific biological functions. Its unique radioactive properties and targeted application make sourcing reliable suppliers critical for healthcare providers, pharmaceutical companies, and nuclear medicine facilities. This article delves into the primary suppliers, manufacturing landscape, regulatory considerations, and market dynamics surrounding Indium-111 Pentetate Disodium.
Regulatory Overview and Market Context
The procurement of Indium-111 Pentetate Disodium is tightly regulated by agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and similar authorities worldwide. Market incumbents must adhere to strict Good Manufacturing Practices (GMP) to ensure the safety, efficacy, and quality of this radiopharmaceutical.
Globally, the proliferation of diagnostic imaging accounts for the growing demand for radiopharmaceuticals like In-111 Pentetate. As imaging techniques advance, the need for high-quality, reliable suppliers becomes essential for maintaining healthcare standards and optimizing patient outcomes.
Key Suppliers of Indium-111 Pentetate Disodium
1. ITG Diagnostics
Overview:
ITG Diagnostics, based in Germany, is a leading provider of radiopharmaceuticals and diagnostics for nuclear medicine. They supply Indium-111 Pentetate Disodium as part of their radiotracer portfolio, with a focus on quality control and regulatory compliance.
Product Details:
- Certified for clinical and research use.
- Consistent batch manufacturing with high purity standards.
- Globally distributed through their extensive network.
Market Position:
ITG is recognized for its robust supply chain, emphasizing radiopharmaceuticals with favorable half-lives suitable for diagnostic imaging.
2. Mallinckrodt Pharmaceuticals
Overview:
A major global pharmaceutical manufacturer, Mallinckrodt offers a range of radiopharmaceuticals, including In-111 compounds. Their reputation is built on decades of experience in nuclear medicine.
Product Details:
- Regulated and approved radiotracers with documented stability.
- Availability through specialized distributors for clinical and research use.
Market Position:
Mallinckrodt’s substantial manufacturing capacity and compliance with international standards provide reliable supply channels, particularly in North America and Europe.
3. Eckert & Ziegler
Overview:
This Germany-based company specializes in medical isotopes and radiopharmaceuticals. They provide In-111 Pentetate for diagnostic imaging procedures.
Product Details:
- Focused on high-quality, innovative radiotracers.
- Emphasizes research-grade and clinical-grade supply consistency.
Market Position:
Their integration of isotope production and radiopharmaceutical manufacturing ensures availability for diverse applications.
4. Advanced Accelerator Applications (AstraZeneca)
Overview:
AstraZeneca’s subsidiary, Advanced Accelerator Applications, produces radiopharmaceuticals for diagnostic and therapeutic purposes, including isotopes like In-111.
Product Details:
- Emphasized on precision medicine.
- Strict adherence to regulatory standards with global distribution.
Market Position:
Their expanding portfolio and focus on nuclear medicine make them a significant supplier for clinical institutes.
5. Local Nuclear Medicine Suppliers and Distributors
Many local or regional medical isotope distributors source In-111 Pentetate Disodium from larger manufacturers and distribute it to healthcare facilities. These include regional radiopharmacy companies that ensure timely supply and compliance with regional regulations.
Manufacturing and Supply Chain Considerations
Production of Indium-111:
In-111 is produced via neutron irradiation of enriched cadmium targets typically in nuclear reactors. The quality of the isotope depends on the reactor type, irradiation parameters, and post-production processing.
Global Supply Constraints:
The limited number of isotope production facilities and the complex logistics involved in transporting radioactive materials impact supplier availability. Strategic partnerships, diversified supply sources, and regional production capabilities can mitigate shortages.
Quality and Purity Assurance:
Suppliers must comply with pharmacopeial standards (e.g., USP, EP), ensuring radionuclide purity, chemical purity, and sterility. Batch validation includes rigorous quality control testing, including radiochemical purity and dosage accuracy.
Regulatory and Certification Landscape
Suppliers are required to adhere to multiple standards:
- GMP: Ensures consistent quality.
- Manufacturing licenses: Approved by local and international authorities.
- Radiation safety standards: Compliance with IAEA guidelines.
- Environmental regulations: Managing radioactive waste.
Procurement professionals should verify supplier adherence to these standards to mitigate compliance risks.
Emerging Trends and Future Outlook
The evolving landscape suggests increased investment in regional isotope production facilities to reduce dependence on aging reactor-based sources. Advanced supply chain management technologies and partnerships foster supply stability.
Additionally, the integration of novel production methods, such as cyclotron-based isotope generation, could broaden availability and diversify the supplier base, impacting future procurement strategies.
Conclusion
Reliable sourcing of Indium-111 Pentetate Disodium hinges upon established manufacturers with validated quality standards and comprehensive regulatory compliance. Key industry suppliers like ITG Diagnostics, Mallinckrodt Pharmaceuticals, Eckert & Ziegler, and AstraZeneca stand out due to their production capacity and global reach. The supply landscape remains influenced by geopolitical, technological, and logistical factors, emphasizing the need for diversified supplier networks and proactive inventory management.
Key Takeaways
- Securing consistent supply of Indium-111 Pentetate Disodium requires engagement with reputable, GMP-compliant manufacturers.
- Geographic diversification and regional production capabilities mitigate risks related to reactor dependencies.
- Maintaining regulatory compliance and quality assurance is critical for safety and efficacy.
- Innovations in isotope production, including cyclotron technology, are poised to influence future supplier dynamics.
- Healthcare providers should actively monitor supplier certifications, batch validation processes, and supply chain resilience strategies.
FAQs
Q1: What are the primary uses of Indium-111 Pentetate Disodium in nuclear medicine?
It is predominantly used for diagnostic imaging, including scintigraphy to assess organ function, detect infections, and evaluate tissue-specific activity.
Q2: How can healthcare providers ensure the quality of In-111 Pentetate Disodium from suppliers?
By verifying supplier compliance with GMP standards, reviewing batch validation reports, and ensuring availability of purity and sterility certificates.
Q3: Are there regional differences in supplier availability for Indium-111 Pentetate?
Yes, supplier presence varies geographically, with major manufacturers concentrated in Europe and North America. Regional distributors often source from these providers.
Q4: What are the challenges in the global supply chain of In-111?
Limited production facilities, complex transportation logistics of radioactive materials, and geopolitical factors can cause supply disruptions.
Q5: What future trends could impact the availability of Indium-111 Pentetate Disodium?
Advancements in isotope production methods, new reactor facilities, and alternative diagnostic radiotracers may influence supply dynamics.
References
- International Atomic Energy Agency (IAEA). Production and Quality Control of Radionuclides.
- U.S. Food and Drug Administration (FDA). Guidance for Industry: Radiopharmaceuticals for Diagnostic Use.
- European Pharmacopoeia. Radiopharmaceuticals – Guidelines for Quality Standards.
- Mallinckrodt Pharmaceuticals Product Catalog.
- Eckert & Ziegler News & Product Portfolio.
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