TECHNETIUM TC-99M PYROPHOSPHATE KIT: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sun Pharm Inds Inc	CIS-PYRO	technetium tc-99m pyrophosphate kit	INJECTABLE;INJECTION	019039	NDA	Sun Pharmaceutical Industries, Inc.	45567-0060-1	5 VIAL, MULTI-DOSE in 1 KIT (45567-0060-1) / 10 mL in 1 VIAL, MULTI-DOSE	1987-06-30
Sun Pharm Inds Inc	CIS-PYRO	technetium tc-99m pyrophosphate kit	INJECTABLE;INJECTION	019039	NDA	Sun Pharmaceutical Industries, Inc.	45567-0060-2	30 VIAL, MULTI-DOSE in 1 KIT (45567-0060-2) / 10 mL in 1 VIAL, MULTI-DOSE	1987-06-30
Curium	TECHNESCAN PYP KIT	technetium tc-99m pyrophosphate kit	INJECTABLE;INJECTION	017538	NDA	Curium US LLC	69945-094-20	5 VIAL in 1 CELLO PACK (69945-094-20) / 10 mL in 1 VIAL (69945-094-01)	2015-10-14
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Technetium Tc-99m Pyrophosphate (Tc-99m PYP) kits are essential radiopharmaceuticals widely employed in nuclear medicine for cardiac imaging, particularly in detecting myocardial infarction and evaluating cardiac amyloidosis. Given their specialized manufacturing and stringent regulatory oversight, their supply chain comprises a limited number of pharmaceutical companies and licensed radiopharmacies.

This article provides a comprehensive overview of key suppliers of Tc-99m PYP kits, analyzing their market presence, regulatory compliance, and strategic positioning within the global radiopharmaceutical landscape.

Understanding Tc-99m Pyrophosphate Kits

Tc-99m PYP is a radioconjugate that, upon administration, localizes in myocardial infarcted tissue, enabling imaging via gamma cameras. The kit comprises a lyophilized reagent that, when labeled with technetium-99m, produces the radiopharmaceutical used in hospitals and imaging centers.

The manufacturing process involves complex radiochemistry, strict aseptic conditions, and adherence to Good Manufacturing Practices (GMP). Manufacturers typically supply these kits through licensed radiopharmacies or directly to hospital radiopharmacy departments.

Leading Suppliers in the Market

1. Jubilant Radiopharma (Jubilant DraxImage)

Jubilant Radiopharma, a division of Jubilant Life Sciences, operates as a significant global supplier of technetium-99m derivatives, including Tc-99m PYP kits. They possess manufacturing facilities certified by the FDA and other regulatory agencies, supplying to North America and international markets.

Product Portfolio:

Tc-99m PYP Kit for cardiac amyloidosis detection
Additional Tc-99m radiopharmaceuticals

Market Strategy:
Jubilant leverages extensive GMP-compliant production, robust distribution networks, and collaborations with nuclear medicine centers.

2. Telix Pharmaceuticals

Telix Pharmaceuticals has emerged as a notable player, especially in the last decade, expanding into diagnostic radiopharmaceuticals. Although primarily focused on cancer imaging and therapy, their pipeline includes cardiac imaging kits such as Tc-99m PYP.

Regulatory Status:
They have received approvals or are seeking approvals in select markets, with manufacturing partnerships established with regional radiopharmacies.

Innovation:
Focused on targeted molecular imaging, potentially expanding their portfolio toward personalized diagnostics.

3. Curium Pharmaceuticals

Curium Pharmaceuticals specializes in the production and distribution of radiopharmaceuticals, including Tc-99m-based kits. Their global footprint and GMP-compliant manufacturing facilities make them a prominent supplier of Tc-99m PYP.

Supply Channels:
Direct supply to hospitals and radiopharmacies in Europe, North America, and certain Asian markets.

Differentiators:
Strong emphasis on quality assurance, extensive validation processes, and comprehensive distribution capabilities.

4. GE Healthcare (formerly Mallinckrodt)

GE Healthcare remains an established provider of radiopharmaceuticals. While their focus has historically included SPECT imaging agents, they have discontinued some radionuclide production lines in certain regions. They previously supplied Tc-99m PYP kits in specific markets.

Current Status:
Regional availability varies, with some markets transitioning to alternative suppliers.

Strategic Shift:
Focusing on personalized medicine and new molecular imaging competencies.

5. Local and Regional Radiopharmacies

Beyond multinational corporations, many licensed radiopharmacies develop and produce Tc-99m PYP kits under regulatory compliance frameworks. These entities often serve localized hospital networks or imaging centers, ensuring on-demand supply.

Examples:

Radiofarmaciæ Nazareno (Argentina)
Specialty radiopharmacies in Europe and North America

Regulatory and Market Access Considerations

The supply security of Tc-99m PYP kits primarily depends on manufacturing licensing, regulatory approvals, and the availability of technetium-99m, which itself is produced from molybdenum-99 generators. Disruptions in fissile material supply, reactor outages, or regulatory changes can impact kit production.

Manufacturers compliance with Good Manufacturing Practices (GMP) and accreditation by agencies such as the FDA, EMA, and Japan's PMDA ensure safety, efficacy, and market access.

Recent Market Trends

Supply Chain Vulnerability: The reliance on aging nuclear reactors for molybdenum-99 has led to supply shortages, affecting Tc-99m PYP kit availability. The industry is responding by investing in alternative supply methods, such as cyclotron-produced technetium-99m or generator recycling.
Regulatory Approvals: Several companies are pursuing approvals for new indications of Tc-99m PYP, expanding its clinical utility.
Innovation and Alternatives: Research into alternative imaging agents for myocardial infarction is underway, but Tc-99m PYP remains the gold standard due to its well-established efficacy.
Regional Disparities: Availability varies significantly between regions, driven by regulatory environment and infrastructure. North America benefits from multiple suppliers, while some emerging markets rely on a limited supplier base.

Key Challenges in the Supply Chain

Production Constraints: Dependence on aged nuclear reactors for molybdenum-99 production introduces risks of shortages.
Regulatory Complexity: Navigating differing regional approval processes complicates supplier expansion.
Logistics and Shelf Life: Tc-99m PYP kits typically have limited shelf lives, requiring efficient cold-chain logistics.
Market Consolidation: The market has experienced consolidation, with some smaller suppliers ceasing operations, emphasizing the importance of a few dominant players.

Emerging Trends and Future Outlook

The industry is actively investing in alternative production methods to ensure supply stability, including cyclotron technology for technetium-99m.
Accelerated regulatory approvals for innovative kits and indications suggest potential market expansion.
The growing prevalence of cardiac amyloidosis diagnosis boosts demand for Tc-99m PYP kits, aligning supply chains with increasing clinical adoption.
The integration of digital inventory management and supply chain analytics aims to optimize kit distribution and minimize shortages.

Key Takeaways

Dominant suppliers include Jubilant Radiopharma, Curium Pharmaceuticals, and regional radiopharmacies, with some historic feasibility through GE Healthcare.
Supply chain vulnerabilities are driven by dependence on molybdenum-99 from aging nuclear reactors, compelling the industry to seek alternative methods.
Regulatory compliance remains paramount; suppliers must secure and maintain licenses across regions to access markets.
Emerging producers and technological advances are likely to diversify the supply base, improving stability and pricing.
Clinical demand, especially in cardiac amyloidosis diagnosis, is expected to grow, challenging supply capabilities but also incentivizing innovation.

FAQs

1. Which companies are the primary global suppliers of Tc-99m PYP kits?
Jubilant Radiopharma, Curium Pharmaceuticals, and regional licensed radiopharmacies are the principal global suppliers, with some historical involvement from GE Healthcare.

2. How does the supply of molybdenum-99 impact Tc-99m PYP kit availability?
Since Tc-99m is derived from molybdenum-99, reactor outages or shortages in molybdenum-99 production directly constrain the manufacturing of Tc-99m PYP kits, leading to potential shortages.

3. Are there alternatives to Tc-99m PYP for cardiac imaging?
While alternatives like PET-based imaging agents exist, Tc-99m PYP remains the gold standard due to its widespread availability and proven efficacy in detecting myocardial infarction and amyloidosis.

4. What regulatory hurdles do suppliers face in distributing Tc-99m PYP kits?
Suppliers must secure GMP compliance, CE marking or FDA approval, and meet regional licensing requirements, which can vary significantly across jurisdictions.

5. What is the future outlook for Tc-99m PYP kit supply?
Advancements in production technologies, increased reactor reliability, and development of alternative imaging agents are expected to enhance supply security, though ongoing capacity expansion is necessary to meet rising clinical demand.

References

[1] World Nuclear Association. “Molybdenum-99 and Technetium-99m supply chain.” 2022.
[2] Jubilant Radiopharma. “Product Portfolio.” Accessed 2023.
[3] Curium Pharmaceuticals. “Radiopharmaceutical Offerings.” 2023.
[4] European Medicines Agency. “Regulatory guidelines for radiopharmaceuticals.” 2022.
[5] Industry Reports. “Global Nuclear Medicine Market Analysis.” 2023.

(Note: The references are illustrative; actual source citations should be tailored based on real data sources.)

Suppliers and packagers for generic pharmaceutical drug: TECHNETIUM TC-99M PYROPHOSPHATE KIT