Suppliers and packagers for AMBISOME

AMBISOME

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Astellas	AMBISOME	amphotericin b	INJECTABLE, LIPOSOMAL;INJECTION	050740	NDA	Astellas Pharma US, Inc.	0469-3051-30	12.5 mL in 1 VIAL, SINGLE-DOSE (0469-3051-30)	1997-08-11

Suppliers for the Pharmaceutical Drug: AMBISOME

Last updated: July 28, 2025

Introduction

AMBISOME is an advanced liposomal formulation of amphotericin B, widely used for treating invasive fungal infections, including cryptococcal meningitis, viscerocutaneous leishmaniasis, and other severe fungal diseases. Known for its enhanced efficacy and reduced toxicity compared to conventional amphotericin B, AMBISOME constitutes a critical asset in infectious disease pharmacotherapy. As demand for this medication persists globally, understanding the key suppliers involved in its manufacturing, distribution, and logistics is vital for stakeholders across healthcare, pharmaceutical, and regulatory sectors.

Manufacturers of AMBISOME

1. Gilead Sciences, Inc.
Gilead remains the primary commercial manufacturer of AMBISOME. The company developed this liposomal formulation in partnership with Fujisawa Pharmaceutical Co., Ltd., now a part of Astellas Pharma, before Gilead acquired rights to the product. Gilead holds the original patent rights and oversees clinical development, manufacturing, and global distribution of AMBISOME (marketed as AmBisome in many regions). Their manufacturing facilities adhere to strict cGMP standards, a critical component ensuring product safety and efficacy.

2. Fujisawa / Astellas Pharma
Prior to Gilead's commercialization, Fujisawa was involved in developing AMBISOME, contributing to its initial formulation and early clinical trials. Although Fujisawa exited the amphotericin B market following corporate restructuring, Astellas Pharma retains certain licensing agreements and maintains legacy supply chains in specific regions.

3. Contract Manufacturing Organizations (CMOs)
While Gilead and Astellas are the primary entities, several CMOs are authorized to produce liposomal amphotericin B formulations under Gilead’s licensing framework, primarily to meet regional demand or bolster supply chain resilience.

Regional Suppliers and Distributors

1. Gilead’s Global Supply Network
As the market leader, Gilead manages a complex global supply chain, including manufacturing sites and distribution hubs across North America, Europe, and Asia. The company partners with regional distributors, such as Cardinal Health, McKesson, and Medline Industries, to facilitate procurement and delivery to hospitals, clinics, and pharmacies.

2. Regional Pharmaceutical Distributors
In markets where Gilead’s direct distribution is limited, authorized regional distributors play pivotal roles. They operate under strict licensing agreements, ensuring compliance with regulatory standards. Examples include distributors in India, Latin America, and Africa, where logistical challenges necessitate local partnerships.

3. Generics and Biosimilar Developers
In some emerging markets, biosimilar or generic versions of liposomal amphotericin B are under development or have received approval, often supplied by local pharmaceutical firms. These are not exact analogs but offer alternative options, especially where Gilead’s product faces pricing or patent barriers.

Regulatory and Licensing Landscape

The supply chain for AMBISOME is heavily influenced by patent protections, licensing agreements, and regulatory approvals. Gilead maintains patent rights in many jurisdictions, restricting the entry of biosimilar products. However, in regions where patents have expired or are not enforced, local manufacturers produce generics, expanding accessibility.

International regulatory agencies, such as the FDA (USA), EMA (Europe), and CDSCO (India), oversee approval processes for all manufacturers and suppliers, ensuring product quality and safety.

Key Challenges in Supply

• Manufacturing Complexity: The liposomal formulation requires sophisticated technology and infrastructure, limiting the number of capable manufacturers.
• Patent and Licensing Restrictions: These influence the entry of generic producers, affecting global supply and pricing.
• Regional Supply Constraints: Variability in regulatory approval times and regional infrastructure can cause supply disruptions.
• Cost and Pricing Pressures: Gilead’s pricing strategy, coupled with regional economic factors, impacts the accessibility of AMBISOME.

Emerging Trends and Future Outlook

The pharmaceutical landscape for AMBISOME is evolving, with increased interest in biosimilars and patent expirations potentially expanding manufacturing capacity. Strategic partnerships and regional production licenses could enhance supply stability, especially in low-resource settings. Advances in liposomal technology and global manufacture standards also promote the possibility of diversified supplier bases in the future.

Conclusion

Gilead Sciences remains the principal global supplier of AMBISOME, leveraging a tightly controlled supply chain to ensure product integrity. Regional distributors, licensed manufacturers, and emerging biosimilar entrants diversify availability, particularly in markets facing patent restrictions or supply bottlenecks. Navigating this landscape requires understanding the complex web of manufacturing, licensing, and regulatory dynamics — critical for stakeholders to optimize procurement and ensure continuous patient access.

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Key Takeaways

• Gilead Sciences is the predominant supplier of AMBISOME, responsible for manufacturing and global distribution.
• Regional distributors and licensed CMOs expand availability but operate within strict regulatory and licensing boundaries.
• Patent protections influence the emergence of biosimilars and generic liposomal amphotericin B products in certain markets.
• Manufacturing complexity and regional regulatory hurdles remain significant challenges impacting supply stability.
• Future growth may hinge on biosimilar development, regional manufacturing partnerships, and technological innovations in liposomal drug production.

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FAQs

1. Who are the main manufacturers of AMBISOME?
Gilead Sciences is the primary manufacturer, with licensing agreements enabling regional production and distribution. Some regional firms and CMOs contribute under licensing or partnership arrangements, especially where patent restrictions apply.

2. Are biosimilars of AMBISOME available globally?
As of 2023, biosimilars of liposomal amphotericin B are limited but emerging in certain markets, primarily driven by patent expirations and local manufacturing capacities.

3. How does Gilead ensure quality across its supply chain?
Gilead enforces rigorous cGMP standards at its manufacturing facilities and audits regional distributors and licensing partners to maintain product integrity and safety.

4. What regions face the most significant supply challenges for AMBISOME?
Emerging markets with patent restrictions, logistical limitations, or underdeveloped regulatory frameworks often experience supply disruptions or delays.

5. Will the supply of AMBISOME increase in the future?
Potentially, through biosimilar development, regional manufacturing partnerships, and technological advances, which may reduce costs and improve access worldwide.

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Sources
[1] Gilead Sciences, Inc. Official Website. "AmBisome." Accessed 2023.
[2] EU Regulatory Approvals for Liposomal Amphotericin B. European Medicines Agency. 2022.
[3] U.S. FDA Approved Drugs Database. "AmBisome." 2023.
[4] Industry Reports on Biosimilar Development. Pharma Compass. 2022.