TRAVASOL 8.5% IN PLASTIC CONTAINER: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare	TRAVASOL 8.5% IN PLASTIC CONTAINER	amino acids	INJECTABLE;INJECTION	018931	NDA	Baxter Healthcare Corporation	0338-0644-03	500 mL in 1 BAG (0338-0644-03)	1984-08-23
Baxter Hlthcare	TRAVASOL 8.5% IN PLASTIC CONTAINER	amino acids	INJECTABLE;INJECTION	018931	NDA	Baxter Healthcare Corporation	0338-0644-04	1000 mL in 1 BAG (0338-0644-04)	1984-08-23
Baxter Hlthcare	TRAVASOL 8.5% IN PLASTIC CONTAINER	amino acids	INJECTABLE;INJECTION	018931	NDA	Baxter Healthcare Corporation	0338-0644-06	2000 mL in 1 BAG (0338-0644-06)	1984-08-23
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Overview of TRAVASOL 8.5% (Amphotericin B Lipid Complex)

TRAVASOL 8.5%, a formulation of amphotericin B, functions primarily as an antifungal agent used predominantly in hospital settings. Typically supplied as a lyophilized powder or liquid in plastic containers, this product is essential for treating systemic fungal infections, especially in immunocompromised patient populations. The specific formulation in a plastic container, especially as an 8.5% solution, signifies a concentrated option for healthcare professionals, demanding stringent manufacturing standards and quality assurance.

Global Manufacturing and Supply Landscape

The supply chain for TRAVASOL 8.5% involves multiple stakeholders, including approved generic manufacturers, original patent holders, and authorized distributors. The availability of this drug hinges on regulatory approvals, manufacturing capabilities, and distribution networks aimed at ensuring pharmaceutical quality and supply continuity.

Given the complex nature of amphotericin B formulations, authorized suppliers maintain rigorous Good Manufacturing Practice (GMP) compliance. Several key players globally serve as primary suppliers, either through direct manufacturing or authorized distribution channels.

Key Suppliers of TRAVASOL 8.5% in Plastic Containers

1. F. Hoffmann-La Roche Ltd. (Hoffmann-La Roche)

As an original manufacturer, Hoffmann-La Roche historically developed and marketed amphotericin B formulations, including TRAVASOL. Although their focus shifted towards newer antifungal agents, the company retained rights to certain formulations in select markets. Roche is known for its stringent quality control and global distribution network.

2. Gilead Sciences Inc.

Gilead’s portfolio in antifungal therapies includes amphotericin B formulations. They manufacture amphotericin B lipid complex products, which are sometimes packaged similarly to TRAVASOL in plastic containers. Their extensive global footprint ensures widespread availability, especially across North America, Europe, and Asia.

3. Cipla Limited (India)

A leading manufacturer of generic injectables, Cipla supplies amphotericin B products, including lipid complex formulations. Their production facilities are GMP compliant, and the company maintains a strong distribution network across emerging markets, making them a critical supplier for hospitals and clinics requiring affordable options.

4. Neilmed Pharmaceuticals, Inc.

Neilmed markets amphotericin B formulations, including those in plastic containers. Their products adhere to international standards for sterility and stability, catering to the US and global markets through partnerships and authorized distributors.

5. Hospira (Part of Pfizer Inc.)

Hospira’s portfolio includes lipid formulations of amphotericin B, often supplied in ready-to-use plastic containers. Their manufacturing facilities are certified according to international standards, and their distribution network spans globally to meet demand.

6. Other Regional Vendors and Generics Manufacturers

Numerous regional suppliers in India, China, and Eastern Europe manufacture TRAVASOL equivalents or generic versions of amphotericin B in plastic containers, particularly in markets with lower entry barriers. These manufacturers often operate under strict regulatory oversight but may vary in quality and certification standards.

Regulatory and Supply Chain Considerations

Regulatory Approvals: Suppliers must possess approvals from agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), or respective national authorities to legally distribute TRAVASOL 8.5%. These are indicative of product quality and safety.
Distribution Channels: Major pharmaceutical distributors, including McKesson, Cardinal Health, and local regional distributors, facilitate the procurement and delivery of TRAVASOL in plastic containers globally.
Supply Constraints: Due to its complex manufacturing and stringent regulatory standards, supply vulnerabilities may occur, particularly from regional manufacturers lacking robust infrastructure.

Market Dynamics and Procurement Strategies

Healthcare providers seeking TRAVASOL 8.5% should prioritize suppliers with proven GMP compliance, robust distribution networks, and verifiable certifications. International procurement is often facilitated via tender-based or direct purchasing agreements supported by authorized distributors to ensure product authenticity and regulatory compliance.

In emerging markets, regional manufacturers often fill supply gaps, but buyers must conduct thorough due diligence regarding quality assurance. Conversely, large healthcare systems and international hospitals frequently source directly from leading global manufacturers or their licensed regional partners.

Key Considerations for Buyers

Authenticity and Quality Assurance: Prioritize authorized suppliers and verify Lot and batch certifications.
Regulatory Status: Confirm product approval status in the relevant jurisdiction.
Supply Reliability: Engage suppliers with a track record of consistent delivery, especially amidst global supply chain disruptions.
Cost and Contract Terms: Balance cost considerations with quality and supply security, leveraging long-term agreements where appropriate.

Conclusion

The supply landscape for TRAVASOL 8.5% in plastic containers comprises a mix of global pharmaceutical giants, regional generics manufacturers, and authorized distributors. The most reliable sources are those with full regulatory approvals, GMP-certified manufacturing facilities, and established distribution networks. Ensuring the procurement of authentic, high-quality products remains paramount for safe, effective patient care.

Key Takeaways

Leading suppliers include Hoffmann-La Roche, Gilead Sciences, Cipla, Neilmed Pharmaceuticals, and Hospira, with regional manufacturers playing vital roles in emerging markets.
Stringent regulatory compliance, quality assurance, and a reliable distribution network are critical factors in supplier selection.
Global supply constraints necessitate early procurement planning and long-term supplier relationships to ensure continuity.
Regional manufacturers often provide more affordable options but require thorough quality vetting due to variable regulatory standards.
Healthcare providers should verify product certification, batch traceability, and supplier credentials before procurement.

FAQs

1. Is TRAVASOL 8.5% available as a generic product?
Yes. Several manufacturers produce generic amphotericin B lipid complex formulations branded as TRAVASOL, especially in India and China. Buyers should verify approvals and certification to ensure quality.

2. How can I verify a supplier’s authenticity?
Confirm the supplier's approval from relevant regulatory bodies (FDA, EMA, etc.), request product certification and batch traceability documentation, and verify manufacturing practices.

3. Are there differences between various suppliers’ TRAVASOL products?
While product formulations are generally consistent, differences may exist in excipients, packaging, and quality assurance protocols. Only compare suppliers with proven GMP certifications.

4. What should I consider when sourcing from regional manufacturers?
Assess their regulatory approvals, manufacturing practices, quality control processes, and track record for consistent supply and product quality.

5. How do supply chain disruptions affect TRAVASOL procurement?
Disruptions can result from manufacturing shutdowns, raw material shortages, or logistical issues, underscoring the importance of diversification among suppliers and early procurement planning.

Sources

[1] U.S. Food and Drug Administration (FDA). Approved Drug Products: Amphotericin B formulations.
[2] European Medicines Agency (EMA). Summary of Product Characteristics for amphotericin B products.
[3] Gilead Sciences. Medical Product Portfolio.
[4] Cipla Ltd. Product catalog and manufacturing standards.
[5] Hospira (Pfizer Inc.). Amphotericin B lipid complex product data.

Suppliers and packagers for TRAVASOL 8.5% IN PLASTIC CONTAINER