Suppliers and packagers for NEPHROSCAN

NEPHROSCAN

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Theragnostics	NEPHROSCAN	technetium tc-99m succimer	POWDER;INTRAVENOUS	214993	NDA	Theragnostics Inc	71083-0020-5	5 VIAL, SINGLE-DOSE in 1 CARTON (71083-0020-5) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71083-0020-1)	2022-02-18

Suppliers for the Pharmaceutical Drug: Nephroscan

Last updated: August 9, 2025

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Introduction

Nephroscan is a diagnostic imaging agent used to evaluate renal function and structure through nuclear medicine procedures. Marketed primarily for renal scintigraphy, it provides clinicians with critical insights into renal perfusion, filtration, and overall kidney health. As a specialized radiopharmaceutical, its supply chain involves tightly regulated manufacturers and distributors adhering to strict quality standards. This article explores the key suppliers of Nephroscan globally, highlighting their roles, regulatory compliance, and strategic positioning within the pharmaceutical landscape.

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Overview of Nephroscan and Its Market

Nephroscan (also referenced under generic or similar radiopharmaceuticals like technetium-based compounds) is typically distributed by a limited network of licensed pharmaceutical companies. Due to its radioactive nature, suppliers must comply with stringent regulatory requirements from agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other jurisdictional authorities. The drug’s demand correlates with the prevalence of renal diseases and the utilization rate of nuclear medicine procedures, which are expanding globally owing to technological advancements and increased screening protocols.

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Major Suppliers of Nephroscan

1. Mallinckrodt Pharmaceuticals

Overview:
Mallinckrodt is a prominent supplier of radiopharmaceuticals, including nephrography agents. The company maintains a global footprint with extensive manufacturing capabilities for radioactive tracers. Since acquiring certain nuclear medicine divisions, Mallinckrodt has strengthened its market presence in nephrology diagnostics.

Supply Capability:

• Large-scale production adhering to cGMP standards (current Good Manufacturing Practice).
• Rich distribution network providing global access, especially across North America and Europe.
• Collaboration with nuclear pharmacies and hospitals for timely delivery of radiopharmaceuticals.

Regulatory Compliance:

• Certified by regulatory authorities for their radiopharmaceutical manufacturing processes.
• Maintains licenses for handling radioactive materials, ensuring safety standards.

2. Curium Pharma

Overview:
Curium Pharma specializes in nuclear medicine diagnostics. The company offers a portfolio that includes renal and cardiac imaging agents, positioning itself as a key player in nephroscan supply. Their focus on innovation and quality positions them as a preferred supplier for many healthcare systems.

Supply Capability:

• Production facilities with advanced radiochemistry labs.
• Ability to distribute across North America, Europe, and Asia-Pacific regions.
• Customizable supply solutions for hospitals and nuclear pharmacies.

Regulatory Compliance:

• Alignment with international radiation safety standards (ISO, IAEA regulations).
• Regular audits and approvals from medical regulatory authorities.

3. GE Healthcare (AstraZeneca Collaboration & Former Radiopharmaceutical Division)

Overview:
GE Healthcare’s legacy includes the production of various radiopharmaceuticals for diagnostic imaging. Although their focus has shifted, they historically supplied agents similar to Nephroscan, with ongoing collaborations to commercialize renal imaging compounds.

Supply Capability:

• Known for extensive distribution channels and advanced manufacturing.
• Strong integration with hospital systems and nuclear medicine centers.

Regulatory Compliance:

• Complies with global radiation safety and pharmaceutical manufacturing standards.

4. Cardinal Health and Nordion

Overview:
These companies are major distributors and licensed producers in the radiopharmaceutical space, providing radiotracers for diagnostic procedures. They often partner with third-party manufacturers to supply Nephroscan equivalents or analogs, depending on regional approvals.

Supply Capability:

• Wide distribution network with emergency, routine, and long-term supply services.
• Support for supply chain management within hospital infrastructure.

Regulatory Compliance:

• Strict adherence to radioactive material handling protocols under international standards.

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Regional Variations and Authorization

The availability of Nephroscan varies significantly by region due to differing regulatory approvals and market presence:

• United States:
  The primary suppliers include Mallinckrodt, Atrium Radiopharmacy, and Cardinal Health, which supply licensed radiopharmaceuticals approved by the FDA.

• Europe:
  Suppliers like Curium and GE Healthcare dominate, with distribution authorized by EMA and local health authorities.

• Asia-Pacific:
  Regional distributors and emerging manufacturers supply radiopharmaceuticals, often through licensed nuclear pharmacies.

Key Point:
Supply chains are highly regulated, with licensing and manufacturing standards dictating regional access to Nephroscan.

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Emerging Suppliers and Technologies

Innovations in radiopharmaceutical production and shifting regulatory landscapes lead to new entrants aiming to supply renal imaging agents. These include biotech startups developing technetium-based compounds with improved imaging qualities and longer shelf lives. Expansion of such suppliers can influence the existing market dynamics, potentially reducing costs and increasing availability.

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Challenges in the Supply Chain

• Regulatory Hurdles:
  Strict licensing and safety standards create barriers that limit rapid entry for new suppliers and affect existing supply sources.

• Logistics and Storage:
  Radiopharmaceuticals like Nephroscan have short half-lives, requiring just-in-time manufacturing and cold-chain logistics, complicating supply stability.

• Regional Disparities:
  Certain markets face shortages due to limited infrastructure, regulatory delays, or commercial disinterest from suppliers.

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Strategic Implications for Stakeholders

Healthcare providers, procurement agencies, and investors should monitor regulatory updates and technological advancements to ensure a reliable supply of Nephroscan. Collaborations with established suppliers like Mallinckrodt and Curium offer security, but emerging technologies may disrupt historical supply patterns.

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Key Takeaways

• Limited but Established Suppliers: The procurement of Nephroscan relies largely on major players like Mallinckrodt and Curium, with stringent regulatory compliance underpinning their supply chains.
• Regional Variability: Availability varies globally, with regulatory approvals tightly controlling access to radiopharmaceuticals.
• Supply Chain Challenges: Short half-lives, logistics complexity, and regulatory hurdles pose ongoing risks to consistent supply.
• Emerging Opportunities: Innovation in radiochemistry may introduce alternative suppliers or improved formulations, impacting market dynamics.
• Strategic Procurement: Stakeholders should develop contingency plans, including diversified sourcing and partnership with reliable licensed distributors.

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FAQs

1. Who are the primary suppliers of Nephroscan in North America?
Mallinckrodt and Cardinal Health are the leading licensed suppliers, providing FDA-approved radiopharmaceuticals for renal imaging.

2. How does regulatory approval affect Nephroscan’s supply?
Regulatory approval ensures manufacturing standards and safe distribution, but delays or restrictions can limit supplier availability and regional access.

3. What logistics challenges exist for supplying Nephroscan?
Its radioactive half-life necessitates rapid manufacturing and distribution, requiring cold-chain logistics to prevent decay and ensure efficacy.

4. Are there regional differences in Nephroscan availability?
Yes, availability depends on local regulatory approvals and infrastructure, leading to variability among continents and countries.

5. Are there alternatives to Nephroscan from new suppliers or technologies?
Emerging radiopharmaceuticals and technetium-based agents are being developed that may serve as alternatives, potentially reducing reliance on traditional suppliers.

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References

1. [1] Mallinckrodt Pharmaceuticals. Corporate Website. Available at: https://www.mallinckrodt.com.
2. [2] Curium Pharma. Corporate Overview. Available at: https://curiumpharma.com.
3. [3] European Medicines Agency. Radiopharmaceutical Approvals. Available at: https://www.ema.europa.eu.
4. [4] U.S. FDA. Guidance on Radiopharmaceuticals. Available at: https://www.fda.gov.

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Conclusion: Ensuring a stable supply of Nephroscan hinges on understanding the complex landscape of licensed radiopharmaceutical manufacturers and distributors. Continuous monitoring of regulatory developments and technological innovations remains essential for stakeholders seeking reliable access to this vital diagnostic agent.