Suppliers and packagers for lumason

lumason

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bracco	LUMASON	sulfur hexafluoride lipid-type a microspheres	FOR SUSPENSION;INTRAVENOUS	203684	NDA	BRACCO DIAGNOSTICS INC	0270-7097-07	20 VIAL in 1 BOX (0270-7097-07) / 25 mg in 1 VIAL	2021-04-01
Bracco	LUMASON	sulfur hexafluoride lipid-type a microspheres	FOR SUSPENSION;INTRAVENOUS	203684	NDA	BRACCO DIAGNOSTICS INC	0270-7097-08	20 VIAL in 1 BOX (0270-7097-08) / 25 mg in 1 VIAL	2021-04-01
Bracco	LUMASON	sulfur hexafluoride lipid-type a microspheres	FOR SUSPENSION;INTRAVENOUS	203684	NDA	BRACCO DIAGNOSTICS INC	0270-7099-16	5 KIT in 1 BOX (0270-7099-16) / 1 KIT in 1 KIT * 25 mg in 1 VIAL * 5 mL in 1 SYRINGE	2015-01-15
Bracco	LUMASON	sulfur hexafluoride lipid-type a microspheres	FOR SUSPENSION;INTRAVENOUS	203684	NDA	BRACCO DIAGNOSTICS INC	0270-7099-73	5 KIT in 1 BOX (0270-7099-73) / 1 KIT in 1 KIT * 25 mg in 1 VIAL * 5 mL in 1 SYRINGE	2015-01-15

Suppliers for the Pharmaceutical Drug: LUMASON

Last updated: August 2, 2025

Introduction

LUMASON (sodium fluorescein injection) is a diagnostic imaging agent developed for ultrasound-enhanced visualization of vascular and tissue structures. As an FDA-approved contrast agent primarily used in echocardiography and other ultrasound procedures, LUMASON’s manufacturing, distribution, and supply chain involve specialized pharmaceutical suppliers committed to quality, safety, and regulatory compliance. This article provides a comprehensive overview of the current suppliers for LUMASON, evaluating the manufacturing landscape, distribution channels, and strategic considerations for stakeholders involved in procurement and supply chain management.

Manufacturers of LUMASON

LUMASON is marketed by GE Healthcare through its pharmaceuticals division. The active pharmaceutical ingredient (API), sodium fluorescein, is sourced from specialized chemical and pharmaceutical suppliers that meet stringent Good Manufacturing Practice (GMP) standards.

Primary Manufacturer: GE Healthcare

GE Healthcare is the sole commercial manufacturer of LUMASON, leveraging its extensive manufacturing facilities optimized for sterile injectable products. Their facilities adhere to global GMP standards, including those set by the FDA, EMA, and other regulatory agencies, ensuring high product quality and safety. GE Healthcare’s vertically integrated model encompasses the synthesis of the sodium fluorescein API, formulation, sterile processing, and packaging.

API Suppliers for Sodium Fluorescein

While GE Healthcare produces the final contrast agent, the sodium fluorescein API itself may originate from specialized chemical suppliers. These API manufacturers are essential suppliers providing high-purity fluorescein suitable for injectable use, complying with pharmacopoeial standards (USP, EP).

Some established suppliers include:

• CordenPharma: A prominent provider of fine chemicals and APIs, CordenPharma offers synthetic fluorescein that meets pharmaceutical grade standards. Their facilities are GMP-compliant, and they serve major pharmaceutical firms globally.

• Aegis Chemicals: Known for manufacturing fluorescein dyes and intermediates, Aegis Chemicals supplies both research-grade and pharmaceutical-grade fluorescein. They emphasize quality assurance and regulatory compliance.

• Sigma-Aldrich/Merck: While primarily a chemical supplier, Sigma-Aldrich offers fluorescein dyes suitable for research and pharmaceutical applications, with some products approved for injectable manufacturing when sourced appropriately.

• TCI Chemicals: Tokyo Chemical Industry provides fluorescein compounds with quality standards that can meet pharmaceutical manufacturing requirements, subject to further validation.

Formulation and Sterile Manufacturing

LUMASON’s production process involves formulation under sterile conditions. This manufacturing requires specialized sterile injectables contractors that partner with the API suppliers and the primary manufacturer.

Contract Manufacturing Organizations (CMOs)

In recent years, pharmaceutical companies often engage CMOs for sterile filling and packaging. For LUMASON, key CMOs include:

• Pfizer Manufacturing: Known for sterile injectable manufacturing capacity, Pfizer’s facilities ensure compliance with regulatory standards necessary for a contrast agent used in clinical diagnostics.

• Patheon (a Thermo Fisher Scientific company): Operates multiple GMP-certified sterile injectable manufacturing sites worldwide, capable of producing high-volume sterile contrast agents.

• Boehringer Ingelheim BioXcellence: Provides contract manufacturing services for complex sterile injectable products, including contrast media.

Distribution Channels for LUMASON

Once manufactured, LUMASON is distributed globally through a network of distribution partners and specialty pharmacies.

Regional Distributors and Suppliers

• GE Healthcare’s Global Distribution Network: As the manufacturer, GE Healthcare manages the logistics and distribution, ensuring product availability across North America, Europe, Asia Pacific, and other regions. Their supply chain emphasizes temperature-controlled storage and transportation to preserve product integrity.

• Regional Distributors: In various markets, authorized regional distributors handle local distribution, regulatory compliance, and inventory management. Examples include McKesson and Cardinal Health in the US, and Henry Schein or local specialty distributors in Europe and Asia.

• Specialty Pharmacies and Hospital Suppliers: LUMASON is often supplied directly to healthcare providers through hospital pharmacies and specialized medical supply companies that handle injectable contrast agents.

Supply Chain Challenges and Considerations

The supply chain for contrast agents like LUMASON involves strict handling requirements, including cold chain logistics, to maintain product stability. The limited number of manufacturers and sourcing constraints of high-purity sodium fluorescein can lead to supply bottlenecks.

Additionally, regulatory approvals restrict manufacturing to GMP-compliant facilities, limiting the number of qualified suppliers. Consequently, any disruption in manufacturing or distribution can impact supply availability.

Strategic Implications for Stakeholders

• For healthcare providers and procurement agents: Engaging with authorized distributors and understanding regional supply chains are vital to ensure consistent access to LUMASON.

• For investors and strategic partners: Monitoring GE Healthcare’s manufacturing capacity and their relationships with API suppliers is critical for assessing future supply stability.

• For competitors: Entry into the market requires significant regulatory clearance, GMP-compliant manufacturing facilities, and established distribution networks.

Regulatory Landscape and Supplier Qualification

Suppliers must comply with international standards such as USP (United States Pharmacopeia), EP (European Pharmacopoeia), and ICH (International Council for Harmonisation). The FDA and EMA inspect manufacturing facilities to ensure GMP compliance, restricting the pool of qualified API suppliers.

GE Healthcare maintains strict supplier qualification programs, auditing their API suppliers regularly to uphold product quality.

Emerging Trends and Future Outlook

The growing demand for contrast agents in diagnostic imaging promotes investment in manufacturing capacity. Suppliers are exploring alternative synthesis methods for sodium fluorescein to diversify supply and minimize reliance on single-source providers.

Additionally, advancements in formulation technology may lead to new suppliers capable of producing stable, higher-purity sodium fluorescein suitable for injectable formulations, potentially expanding the supplier network.

Key Takeaways

• GE Healthcare is the exclusive manufacturer of LUMASON, with high-quality sterile production and a global distribution network.

• API sourcing for sodium fluorescein involves specialized chemical suppliers like CordenPharma and Sigma-Aldrich, adhering to GMP standards.

• Contract manufacturing organizations play a crucial role in sterile filling, packaging, and distribution, ensuring regulatory compliance and product integrity.

• Supply chain management is complex, emphasizing cold chain logistics, supplier qualification, and regional distributor partnerships to ensure consistent availability.

• Future supply stability depends on diversifying API sources, expanding manufacturing capacity, and technological innovations in formulation and synthesis.

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Key Takeaways

1. Limited but Qualified Supplier Pool: The manufacturing of LUMASON relies on a select group of GMP-compliant API suppliers and CMOs, emphasizing the importance of quality assurance and regulatory compliance.

2. Strategic Partnerships Are Crucial: GE Healthcare’s integrated supply chain underpins the global distribution of LUMASON, with partnerships extending to specialty distributors and hospital suppliers.

3. Supply Chain Vulnerabilities Must Be Managed: The specialized nature of the product and regulatory requirements create potential bottlenecks, making supply chain resilience a priority.

4. Regulatory Compliance Defines the Market: Strict GMP standards and regulatory approvals restrict supplier plurality, highlighting the necessity for rigorous qualification and quality monitoring.

5. Future Supply Dynamics: Emerging manufacturing technologies and alternative sourcing strategies are poised to influence the competitive landscape, potentially enhancing supply security.

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FAQs

1. Who are the primary manufacturers of LUMASON?
GE Healthcare is the sole commercial manufacturer of LUMASON, overseeing formulation, sterile manufacturing, and distribution globally.

2. From which suppliers does GE Healthcare source sodium fluorescein?
While specific supplier details are proprietary, prominent chemical suppliers like CordenPharma and Sigma-Aldrich are known to provide pharmaceutical-grade fluorescein consistent with GMP standards.

3. Are there alternative suppliers capable of producing sodium fluorescein for LUMASON?
Currently, the supply chain is limited to GMP-certified manufacturers like CordenPharma, but emerging chemical producers and synthesis technologies could diversify sources in the future.

4. How does the distribution of LUMASON ensure product integrity?
Distribution is managed through temperature-controlled logistics, with partnerships involving regional distributors and specialty pharmacies to maintain product stability and regulatory compliance.

5. What are the key challenges in the supply chain for LUMASON?
Major challenges include sourcing high-purity sodium fluorescein, managing cold chain logistics, and maintaining compliance with evolving regulatory standards to prevent supply disruptions.

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References

[1] GE Healthcare. “LUMASON – Product Overview,” GE Healthcare, 2022.
[2] U.S. Food and Drug Administration. “FDA Approval Details for LUMASON,” FDA, 2017.
[3] CordenPharma. “High-Quality Sodium Fluorescein Sourcing,” CordenPharma, 2021.
[4] European Medicines Agency. “Guidelines on GMP Standards for Injectable Products,” EMA, 2020.
[5] McKesson and Cardinal Health. “Medical Distribution Networks for Contrast Agents,” Industry Reports, 2022.