Suppliers and packagers for generic pharmaceutical drug: PERFLUTREN

PERFLUTREN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064	NDA	Lantheus Medical Imaging, Inc.	11994-011-01	1 VIAL, GLASS in 1 CARTON (11994-011-01) / 1.5 mL in 1 VIAL, GLASS	2001-07-31
Lantheus Medcl	DEFINITY RT	perflutren	INJECTABLE;INTRAVENOUS	021064	NDA	Lantheus Medical Imaging, Inc.	11994-011-01	1 VIAL, GLASS in 1 CARTON (11994-011-01) / 1.5 mL in 1 VIAL, GLASS	2001-07-31
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064	NDA	Lantheus Medical Imaging, Inc.	11994-011-04	4 VIAL, GLASS in 1 CARTON (11994-011-04) / 1.5 mL in 1 VIAL, GLASS	2001-07-31

Suppliers for the Pharmaceutical Drug: PERFLUTREN

Last updated: July 27, 2025

Introduction

Perflutren, marketed under various brand names including PERFLUTREN, is a lipid-based, ultrasonic contrast agent introduced primarily for diagnostic imaging. It enhances ultrasound imaging of the heart and other organs, facilitating improved detection of pathologies such as cardiomyopathies and vascular lesions. Since its approval, the supply chain for Perflutren has involved multiple manufacturers, subcontractors, and raw material providers. This analysis examines the key suppliers involved in the production of Perflutren, outlining their roles, geographic distribution, and significance within the pharmaceutical supply network.

Manufacturers and Originators

Perflutren's original formulation was developed and marketed by Bracco Diagnostic Inc., a subsidiary of Bracco S.p.A., headquartered in Italy. Bracco remains the dominant provider of the branded product, overseeing the manufacturing, distribution, and pharmacovigilance processes. Their extensive global distribution network ensures that Perflutren reaches healthcare facilities worldwide.

Raw Material Suppliers

The manufacturing of Perflutren involves complex chemical processes utilizing perfluorocarbon compounds, lipids, and other specialized excipients. The key raw materials include:

• Perfluorocarbon gases: These constitute the core contrast-enhancing component. Suppliers such as DuPont (now part of Chemours) and 3M have historically produced high-purity perfluorocarbon gases like perfluoropropane or perfluorobutane. These gases are synthesized through proprietary fluorination processes and require strict quality control.

• Lipids and emulsifiers: The lipid shell encapsulating the perfluorocarbon core involves phospholipids and surfactants. Major global suppliers like Lipoid GmbH (Germany) and Avanti Polar Lipids (USA) provide pharmaceutical-grade lipids that meet stringent purity standards.

• Packaging and Containers: Medical-grade rubber stoppers, vials, and syringes are supplied by companies like West Pharmaceutical Services and WestRock. These components are essential to maintain sterility and stability.

Formulation and Contract Manufacturing

Many pharmaceutical companies engage Contract Manufacturing Organizations (CMOs) to produce Perflutren formulations under licensing agreements. Notable CMOs include:

• GE Healthcare: Historically involved in the production and distribution of ultrasound contrast agents, although their involvement has shifted with market dynamics.
• PATEXIS GmbH: Known for contract production of lipid-based formulations.
• Facility locations in Europe and North America ensure compliance with Good Manufacturing Practices (GMP) and facilitate rapid supply in response to demand.

Distribution Networks and Supply Chain Partners

Distribution channels for Perflutren involve a mix of wholesalers, logistics providers, and regulatory bodies:

• Logistics Providers: Companies like DHL, FedEx, and UPS handle temperature-sensitive storage and transportation.
• Regional Distributors: In the U.S., companies like Cardinal Health and McKesson distribute units to hospitals and clinics.
• Regulatory Authorities: The European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and other agencies oversee compliance and ensure quality standards.

Market Dynamics and Key Players

While Bracco maintains exclusive rights to the branded Perflutren, generic manufacturers have entered the market by developing bioequivalent or alternative formulations. This proliferation has diversified the supplier landscape.

• Liebel-Flarsheim (a part of Cardinal Health): Serves as a key distributor of contrast agents, including generic equivalents.
• Advanced Medical Solutions: Specializes in the production of lipid emulsions for parenteral nutrition and imaging.

Regulatory and Procurement Considerations

Suppliers must adhere to rigorous regulatory standards, including ISO 13485 certification, and comply with environmental and safety protocols due to the handling of perfluorocarbons. Procurement decisions are often influenced by the geopolitical landscape, patent statuses, and the capacity of raw material suppliers to scale production.

Challenges and Supply Chain Risks

The supply chain for Perflutren faces several challenges:

• Raw Material Scarcity: Limited producers of high-quality perfluorocarbons can pose bottlenecks.
• Environmental Regulations: Increasing restrictions on perfluorocarbon emissions and manufacturing processes impact supplier operations.
• Manufacturing Complexities: The delicate formulation process requires highly specialized facilities and expertise.

Conclusion

The supply of Perflutren hinges on a complex network of raw material producers, contract manufacturers, and distribution partners primarily headquartered in Europe and North America. With a high degree of technical specificity and regulatory oversight, the supply chain's robustness depends on the coordination of these specialized entities. As the market evolves, diversification of suppliers—particularly those manufacturing core components—becomes vital to mitigate risks and ensure uninterrupted supply.

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Key Takeaways

• Major suppliers include Bracco (formulation and distribution), raw material providers such as Lipoid GmbH, Avanti Polar Lipids, and perfluorocarbon gas producers like Chemours.
• Raw materials—perfluorocarbon gases and phospholipids—are sourced predominantly from specialized, high-quality suppliers with global reach.
• Contract manufacturing organizations contribute significantly to formulation production, ensuring compliance with regulatory standards.
• Distribution involves logistics providers and regional wholesalers, emphasizing the importance of cold chain management.
• Ongoing challenges center on raw material scarcity, environmental regulations, and manufacturing complexities, necessitating strategic supplier diversification.

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FAQs

1. Who are the primary raw material suppliers for Perflutren?
   Key raw material suppliers include Chemours (perfluorocarbon gases), Lipoid GmbH, and Avanti Polar Lipids (phospholipids), providing essential ingredients under strict regulatory compliance.

2. Are there generic equivalents of Perflutren, and who supplies them?
   Yes. Several generic manufacturers supply alternatives, often produced through contract manufacturing arrangements with smaller biotech firms and regional distributors.

3. What are the main challenges in the supply chain for Perflutren?
   Scarcity of high-purity perfluorocarbon gases, regulatory restrictions on environmental emissions, and manufacturing complexity pose significant risks.

4. Do regulatory agencies influence supplier choices?
   Absolutely. Compliance with agencies like the FDA and EMA impacts supplier selection, requiring certifications such as GMP, ISO 13485, and environmental compliance.

5. How does environmental regulation impact Perflutren’s raw materials?
   Stricter environmental controls on perfluorocarbon emissions limit production capacity for some raw materials, prompting suppliers to adopt cleaner technologies or seek alternatives.

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References

1. Bracco Diagnostics Inc. – Product literature and official disclosures.
2. Chemours Company – Perfluorocarbon gas production details.
3. Lipoid GmbH & Avanti Polar Lipids – Raw material specifications.
4. U.S. FDA & EMA – Regulatory guidelines on contrast agents and environmental compliance.
5. Industry reports and market analyses on contrast agent supply chains.