MPI INDIUM DTPA IN 111: Pharmaceutical manufacturers, suppliers, and distributors

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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

Last updated: August 5, 2025

Introduction

MPI Indium DTPA in 111, a radiopharmaceutical primarily used in nuclear medicine diagnostics, requires precise sourcing from specialized suppliers capable of providing high-purity, radiolabeled compounds adhering to stringent quality standards. This imaging agent, Indium-111 DTPA (diethylenetriamine pentaacetate) labeled with Indium-111, facilitates imaging of the kidneys and other organs, relying on suppliers with advanced radiochemistry capabilities. With a market driven by clinical demand and regulatory approval, identifying reliable suppliers is crucial for pharmaceutical companies, healthcare providers, and researchers seeking consistency, safety, and regulatory compliance.

Overview of MPI Indium DTPA in 111

MPI Indium DTPA in 111 is a radiopharmaceutical agent where the chelating compound DTPA is radiolabeled with the radioisotope Indium-111 (half-life ~2.8 days). Its applications include renal imaging, assessment of kidney function, and potentially tumor detection. Given the complexity of its manufacture and handling, suppliers must meet industry standards such as Good Manufacturing Practice (GMP), ISO certification, and regulatory approvals from agencies like the FDA, EMA, or relevant local authorities. The unique requirements emphasize the importance of choosing suppliers with proven expertise in radiopharmaceuticals.

Major Global Suppliers of MPI Indium DTPA in 111

1. Eckert & Ziegler Radiopharma

Eckert & Ziegler, a leading provider in radiopharmaceuticals and medical isotopes, supplies a comprehensive portfolio of Indium-111 labeled compounds, including DTPA-based preparations. They manufacture under strict GMP standards, ensuring high purity and consistent radiolabeling quality. Their extensive distribution network spans Europe, North America, and Asia, making them a pivotal supplier for hospitals and research institutions.

Key attributes:

ISO 13485 certified manufacturing facilities
Extensive experience with Indium-111 radiolabeling
Global distribution capabilities

2. Mallinckrodt Pharmaceuticals

Mallinckrodt is renowned for its extensive radiopharmaceutical portfolio, including Indium-111 DTPA formulations. Their products are FDA-approved, globally distributed, and manufactured following rigorous quality controls, ensuring safety and efficacy. The company's expertise encompasses radiochemistry, logistics, and regulatory compliance, positioning them as a trusted supplier.

Key attributes:

FDA and EMA authorizations
Well-established supply chain
Focus on clinical and diagnostic radiopharmaceuticals

3. Bracco Imaging

Bracco specializes in diagnostic imaging agents, including Indium-111 DTPA kits, serving the nuclear medicine community with high-quality products. Their systems are supported by comprehensive analytical testing, with products tailored for imaging applications. Bracco’s regional offices and distribution channels facilitate widespread access globally.

Key attributes:

Innovative radiopharmaceutical formulations
Regulatory and clinical support
Strong presence in Europe and North America

4. Isotopia Laboratories (a part of Bionova Scientific)

Isotopia Laboratories offers custom radiopharmaceutical manufacturing, including Indium-111 DTPA. Their capabilities include GMP grade production, process development, and analytical testing suited for research and clinical-grade materials. They focus on bespoke solutions and rapid turnaround times.

Key attributes:

Custom radiopharmaceutical production
Emphasis on research and clinical-grade quality
Advanced radiochemistry capabilities

5. Research-specific Suppliers and Regional Distributors

Numerous smaller regional suppliers or distributors collaborate with larger manufacturers or produce locally sourced radiopharmaceuticals under licensed frameworks. Notable examples include Jubilant Radiopharma (India), Curium Pharma (Europe), and Jubilant Radiopharmaceuticals, which often source or distribute Indium-111 DTPA kits. Their offerings typically serve regional clinical needs and research institutions, albeit with variations in availability and regulatory scope.

Regulatory and Quality Considerations

Suppliers must comply with international standards such as the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and regional GMP guidelines. Verification includes batch validation, radiochemical purity (typically >95%), sterility, and apyrogenicity. Due to the radiolabeled nature, logistics, storage, and handling must adhere to radioactivity regulations, emphasizing local licensing and transportation safeguards.

Applications and Industry Trends

The demand for MPI Indium DTPA in 111 continues to grow, driven by an aging population and increasing emphasis on minimally invasive diagnostics. Suppliers are investing in process automation, improved radiolabeling techniques, and regional manufacturing hubs to meet rising demand. Innovations such as kit-based preparation or centralized radiopharmacy models are enhancing availability while reducing costs.

Conclusion

Reliable sourcing for MPI Indium DTPA in 111 requires engagement with suppliers possessing robust manufacturing infrastructure, compliance with regulatory standards, and proven distribution networks. Major players like Eckert & Ziegler, Mallinckrodt, Bracco, and Isotopia provide validated, high-purity formulations suitable for clinical diagnostics. Smaller regional entities augment coverage, offering flexibility for localized needs. Ensuring quality, regulatory compliance, and timely supply remains paramount for successful adoption in clinical practice and research.

Key Takeaways

Leading suppliers with global reach and stringent quality standards include Eckert & Ziegter, Mallinckrodt, Bracco, and Isotopia.
Regulatory compliance (GMP, FDA, EMA) is critical, given the radiopharmaceutical’s safety profile.
Maintain rigorous verification of radiochemical purity, sterility, and radiation safety during procurement.
Regional suppliers can fulfill localized demands but should be vetted against applicable quality standards.
Technological advances, like kit-based formulations, are enhancing supply flexibility and reducing costs.

FAQs

1. What are the primary considerations when sourcing MPI Indium DTPA in 111?
Manufacturers must ensure high radiochemical purity, compliance with GMP standards, reliable logistics for radioactive materials, and proper regulatory certifications.

2. Are there regional limitations for obtaining Indium-111 DTPA?
Yes. Regulatory approvals, licensing, and logistical capabilities vary regionally. Larger suppliers generally offer global distribution, while regional entities serve local markets.

3. Can MPI Indium DTPA in 111 be prepared in-house, or should it be purchased ready-made?
It can be prepared in high-end radiopharmacies with proper facilities and expertise. However, most institutions prefer procuring ready-made, GMP-compliant formulations to ensure safety and consistency.

4. What safety standards should suppliers meet for Indium-111 radiopharmaceuticals?
Suppliers must adhere to national and international radiological safety standards, including proper shielding, contamination control, and compliance with transportation regulations for radioactive substances.

5. How is quality assurance maintained in radiopharmaceutical supplies?
Through rigorous testing of each batch for radiochemical purity, sterility, endotoxin levels, and stability, alongside comprehensive documentation and regulatory audits.

References

European Pharmacopoeia (Ph. Eur.). Radiopharmaceuticals monograph, 10th Edition.
U.S. Food and Drug Administration (FDA). Guidance for Industry: Radiopharmaceutical Best Practices.
Eckert & Ziegler AG. Product specifications and distribution policies.
Mallinckrodt Pharmaceuticals. Product datasheets and regulatory filings.
Bracco Imaging. Official product documentation and regional approvals.
Isotopia Laboratories. Radiopharmaceutical manufacturing capabilities.

(Note: This content synthesizes general knowledge and publicly available information about suppliers of MPI Indium DTPA in 111 as of 2023, not specific provider endorsements.)

Suppliers and packagers for MPI INDIUM DTPA IN 111