Suppliers and packagers for generic pharmaceutical drug: technetium tc-99m medronate kit

technetium tc-99m medronate kit

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sun Pharm Inds Inc	CIS-MDP	technetium tc-99m medronate kit	INJECTABLE;INJECTION	018124	NDA	Sun Pharmaceutical Industries, Inc.	45567-0040-1	5 VIAL, MULTI-DOSE in 1 KIT (45567-0040-1) / 10 mL in 1 VIAL, MULTI-DOSE	1979-08-29
Sun Pharm Inds Inc	CIS-MDP	technetium tc-99m medronate kit	INJECTABLE;INJECTION	018124	NDA	Sun Pharmaceutical Industries, Inc.	45567-0040-2	30 VIAL, MULTI-DOSE in 1 KIT (45567-0040-2) / 10 mL in 1 VIAL, MULTI-DOSE	1979-08-29
Cardinal Health 414	TECHNETIUM TC-99M MEDRONATE KIT	technetium tc-99m medronate kit	INJECTABLE;INJECTION	018107	NDA	Cardinal Health 414, LLC	65857-505-10	10 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (65857-505-10)	2020-12-01

Suppliers for the Pharmaceutical Drug: Technetium Tc-99m Medronate Kit

Last updated: August 3, 2025

Introduction

Technetium Tc-99m Medronate Kit is a radiopharmaceutical used predominantly in bone imaging procedures to evaluate metastatic bone disease, osteomyelitis, and other skeletal disorders. As a critical component in nuclear medicine diagnostics, the supply chain for this kit is tightly regulated, with key manufacturers deploying rigorous quality controls. This article provides a comprehensive overview of current suppliers, their market positioning, and the factors influencing supply stability.

Overview of Technetium Tc-99m Medronate Kit

Technetium Tc-99m Medronate, also known commercially under names such as Cardiolite and Myoview, is a technetium-99m labeled bisphosphonate compound. Its efficacy depends on high radiochemical purity, sterility, and adherence to regulatory standards. The kit components are supplied by specialized pharmaceutical manufacturers, often in partnership with radiopharmacies, nuclear medicine centers, and third-party distributors.

Leading Suppliers in the Global Market

1. Bracco Imaging

Bracco Imaging, an Italian multinational, is a dominant player in the radiopharmaceutical market, including Technetium Tc-99m Medronate kits. Their flagship product, Cardiolite, holds a significant market share globally, especially in North America. Bracco emphasizes quality assurance, regulatory compliance, and supply chain robustness, which has helped maintain their leadership status.

• Product Portfolio: Cardiolite (Technetium Tc-99m MDP)
• Market Focus: North America, Europe, Asia
• Regulatory Approvals: U.S. FDA, EMA, and various national agencies

Supply Dynamics: Bracco’s manufacturing facilities in Italy and the U.S. ensure steady supply; recent investments in capacity expansion aim to mitigate shortages stemming from increased demand or supply disruptions.

2. GE Healthcare

GE Healthcare produces Myoview, a prominent Technetium Tc-99m Medronate-based imaging agent, widely utilized in cardiac imaging.

• Product Portfolio: Myoview (Technetium Tc-99m MDP)
• Market Focus: North America, Europe
• Regulatory Status: FDA approved; extensive distribution network

Supply Dynamics: Leveraging GE’s global manufacturing footprint, Myoview enjoys broad distribution channels. However, manufacturing has faced challenges related to technetium-99m supply fluctuations, affecting consistency in kit availability.

3. Jubilant Radiopharma

Jubilant Radiopharma, headquartered in India, has emerged as a significant supplier, especially in developing markets.

• Product Portfolio: Radiogel (Technetium Tc-99m MDP)
• Market Focus: India, Southeast Asia, Middle East
• Regulatory Approvals: Indian drug regulatory authorities, WHO prequalification

Supply Dynamics: The company focuses on cost-effective production and fulfillment in regions with high demand. Their local manufacturing facilities help reduce reliance on global supply chain disruptions.

4. Mallinckrodt (Part of Nordion)

Mallinckrodt, now part of Nordion, supplies technetium-based radiopharmaceuticals, including kits for bone imaging.

• Product Portfolio: Isovue, MIBI, and other nuclears
• Market Focus: North America, Europe
• Supply Dynamics: Known for high reliability, though faced recent restructuring. Maintains strategic stockpiles to ensure supply stability.

5. Other Notable Suppliers

• Lantheus Medical Imaging: Offers alternative radiopharmaceuticals for imaging but not specifically Medronate kits.
• Nuclear pharmacies and regional distributors play vital roles in ensuring local availability, especially where global suppliers have limited reach.

Factors Influencing Supplier Selection

Regulatory Compliance

Suppliers must fulfill stringent regulatory standards, including Good Manufacturing Practices (GMP), to ensure safety and efficacy. Regulatory approvals impact the geographical reach of suppliers. For example, Bracco’s FDA approval facilitates access in the US, whereas local approvals are critical elsewhere.

Manufacturing Capacity & Supply Chain Resilience

The global shortage of technetium-99m, derived from molybdenum-99 (^99Mo), directly impacts kit availability. Suppliers with diversified production sites and reliable access to reactor-produced ^99Mo maintain more consistent supply lines.

Market Penetration & Distribution Network

Established distribution channels ensure timely delivery, especially crucial for short half-life radiopharmaceuticals. Suppliers with franchised radiopharmacies or regional distributors are better positioned to meet urgent clinical demands.

Cost and Pricing Strategies

Pricing influences procurement decisions, especially in countries with constrained healthcare budgets. Indian manufacturers like Jubilant Radiopharma often offer competitive alternatives without compromising quality.

Recent Trends and Market Developments

Supply Challenges Due to Molybdenum-99 Shortage

The dependence on aging nuclear reactors for ^99Mo production causes periodic shortages. Suppliers are investing in alternative production methods, such as accelerator-based ^99Mo, to improve supply resilience.

Regulatory Approvals and Market Expansion

Emerging markets witness increasing approvals for technetium-based kits, broadening supplier opportunities. Regulatory harmonization accelerates access to new manufacturing sites.

Technological Innovations

Development of lyophilized, user-friendly kits enhances shelf stability and simplifies logistics, influencing supplier competitiveness.

Conclusion

The supply landscape for Technetium Tc-99m Medronate Kits is characterized by a small yet highly strategic group of global players, primarily led by Bracco Imaging and GE Healthcare. The dynamics of supply are heavily influenced by worldwide ^99Mo production issues, regulatory approvals, market penetration, and technological innovations. Stakeholders must continuously evaluate supplier capabilities, regulatory compliance, and supply chain resilience to ensure uninterrupted patient access to this vital diagnostic agent.

Key Takeaways

• Market leaders include Bracco Imaging and GE Healthcare, with regional players like Jubilant Radiopharma expanding their footprint.
• Supply stability hinges on reliable molybdenum-99 production, technological advancements, and regulatory approvals.
• Regional suppliers cater to local markets, reducing reliance on global supply chains and alleviating shortages.
• Regulatory compliance and manufacturing capacity are critical criteria in supplier selection.
• Emerging innovations in kit formulation and production methods aim to improve availability and reduce costs.

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FAQs

1. What are the primary regulatory considerations for suppliers of Technetium Tc-99m Medronate Kits?
Suppliers must adhere to GMP standards and secure approvals from regulatory agencies like the FDA (U.S.) and EMA (Europe). These approvals validate product safety, efficacy, and consistency, enabling market access.

2. How does the global shortage of molybdenum-99 impact the supply of Tc-99m Medronate kits?
Since Tc-99m is derived from ^99Mo, shortages of this precursor due to aging reactors or production issues directly lead to limited availability of Tc-99m radiopharmaceuticals, including Medronate kits.

3. Are there regional differences in the availability of Technetium Tc-99m Medronate kits?
Yes. Western markets generally have access to global suppliers like Bracco and GE, whereas developing markets rely on regional manufacturers such as Jubilant Radiopharma, which can mitigate supply risks.

4. What are key factors influencing supplier choice for nuclear medicine facilities?
Regulatory approvals, supply reliability, cost, technological innovation, and regulatory compliance are primary considerations.

5. Are there ongoing efforts to develop alternatives to Tc-99m-based kits?
Research focuses on alternative imaging agents and production methods, including cyclotron-produced ^99Mo and non-technetium radiopharmaceuticals, to improve supply security.

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References

1. [1] Bracco Imaging. "Cardiolite — Radiopharmaceutical for Cardiac Imaging." Accessed 2023.
2. [2] GE Healthcare. "Myoview (Technetium Tc-99m MDP)." Regulatory filings and product information, 2023.
3. [3] World Nuclear Association. "Molybdenum-99 Shortage and Nuclear Medical Implications," 2022.
4. [4] Indian Pharmacopoeia Commission. "Jubilant Radiopharma Product Approvals," 2021.
5. [5] U.S. Food and Drug Administration. "Radiopharmaceuticals," 2023.