Suppliers and packagers for generic pharmaceutical drug: anidulafungin

anidulafungin

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Vicuron Holdings	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632	NDA	Roerig	0049-0114-28	15 mL in 1 VIAL, SINGLE-USE (0049-0114-28)	2006-02-17
Vicuron Holdings	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632	NDA	Roerig	0049-0116-28	30 mL in 1 VIAL, SINGLE-USE (0049-0116-28)	2006-02-17
Vicuron Holdings	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632	NDA	Roerig	0049-2242-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0049-2242-01) / 30 mL in 1 VIAL, SINGLE-DOSE	2024-02-20

Suppliers for the Pharmaceutical Drug: Anidulafungin

Last updated: August 5, 2025

Introduction

Anidulafungin is a potent antifungal medication classified as an echinocandin. Widely used in treating invasive fungal infections such as candidaemia and invasive candidiasis, anidulafungin’s therapeutic efficacy relies heavily on a complex and tightly regulated supply chain. Its manufacturing, distribution, and procurement involve multiple key players, including API (Active Pharmaceutical Ingredient) suppliers, formulation manufacturers, and distributors. This analysis evaluates the leading suppliers of anidulafungin, details their market positions, and offers insights into supply chain dynamics, highlighting considerations crucial for pharmaceutical companies and healthcare providers.

Overview of Anidulafungin Production

Anidulafungin, developed by Pfizer, was first approved by the FDA in 2006. Its synthesis involves advanced fermentation processes, complex chemical modifications, and stringent quality controls. The supply chain encompasses:

• API synthesis and bulk manufacturing
• Formulation and packaging
• Distribution and logistics

The API is primarily produced through microbial fermentation processes involving Aspergillus and Glarea species, with subsequent chemical modifications to optimize activity and stability.

Major API Suppliers for Anidulafungin

1. Samsung Biologics

Samsung Biologics is emerging as a significant player in the biopharmaceutical API space, including complex molecules like anidulafungin. With advanced fermenters and quality standards compliant with ISO and cGMP,Samsung offers reliable API manufacturing services. Their capacity expansion suggests a strategic intent to capture market share for niche antifungal APIs.

• Strengths: High manufacturing capacity, robust quality systems, and strategic investments in biotech fermenters.
• Limitations: Not a primary producer of anidulafungin specifically; primarily supplies related biosimilar APIs.

2. Fujifilm Toyama Chemical

Fujifilm Toyama Chemical, a division of Fujifilm Corporation, specializes in antifungal APIs, including anidulafungin. Their fermentation technology closely aligns with Pfizer’s original synthesis process, making them a strategic supplier for generic and biosimilar development.

• Strengths: Established expertise in antifungal API manufacturing, proven microbiological fermentation capabilities.
• Limitations: Limited global reach compared to larger scale, multinational manufacturers.

3. Bachem AG

Bachem AG, based in Switzerland, is a leading producer of peptide and complex small molecules, including APIs relevant to antifungal drugs. They supply custom synthesis services for complex APIs requiring high specificity.

• Strengths: Expertise in complex chemical syntheses, high-quality production standards.
• Limitations: Not a primary manufacturer for large-scale API production specific to anidulafungin.

4. Astellas Pharma

Although primarily a pharmaceutical company rather than an API supplier, Astellas engages in licensing and collaborative manufacturing of antifungal APIs, including anidulafungin, especially for regional markets. They operate manufacturing facilities in Japan and Southeast Asia.

• Strengths: Proven manufacturing quality, regional infrastructure, and developmental expertise.
• Limitations: Dependent on licensing agreements, limiting direct procurement.

5. Contract Manufacturing Organizations (CMOs)

Several CMOs globally, including Lonza, Samsung Biologics, and WuXi AppTec, offer manufacturing services for complex APIs like anidulafungin, often under licensing or bulk supply agreements.

• Key CMOs:
  • Lonza (Switzerland): Known for high-quality small molecule and peptide synthesis.
  • WuXi AppTec (China): Expanding capabilities and capacity for complex APIs.

Note: Due to the specialized nature of anidulafungin, some API manufacturing is restricted to a few strategic players, ensuring supply chain security.

Distribution and Regional Suppliers

In addition to API manufacturers, regional distributors play critical roles in delivering anidulafungin to healthcare systems. Major pharmaceutical distributors like McKesson, Cardinal Health, and Alliance Healthcare stock formulations produced by Pfizer and licensed manufacturers, ensuring availability across global markets.

Regional considerations:

• Asia-Pacific: Dominated by local manufacturers and licensed generics companies.
• North America & Europe: Primarily supplied by Pfizer and select licensed manufacturers.
• Emerging Markets: Local manufacturing and licensing arrangements often supplement global supply channels.

Supply Chain Challenges and Risks

The supply landscape for anidulafungin faces several challenges:

• Manufacturing Complexity: Its fermentation-based synthesis involves strict control of microbial fermentation conditions, impacting yields and scalability.
• Regulatory Hurdles: Regulatory compliance across different jurisdictions can delay supply or restrict market access.
• Raw Material Availability: Fluctuations in microbial culture ingredients and chemicals affect primary API manufacturing.
• Patent and Licensing: Patent protections and licensing agreements limit the number of API suppliers, concentrating supply risk.
• Pandemic Disruptions: COVID-19 impacted global supply chains, causing shortages and delays.

Market Dynamics and Future Outlook

The increasing prevalence of invasive fungal infections in immunocompromised patients sustains demand growth for anidulafungin. Patent expirations and the advent of biosimilars could diversify suppliers in the future. Strategic partnerships, licensing, and capacity expansion by leading manufacturers could mitigate supply risks. The ongoing development of alternative echinocandins and broadening regional manufacturing capabilities might reshape the supply landscape over the next decade.

Key Takeaways

• Limited but Specialized API Suppliers: The production of anidulafungin involves a highly specialized fermentation process, with manufacturers like Fujifilm Toyama Chemical and licensed CMOs serving as primary API sources.
• Supply Chain Concentration: The market exhibits a degree of concentration in API supply, posing potential risks to consistent availability.
• Regional Variability: Procurement strategies should consider regional manufacturing capabilities, regulatory stipulations, and distribution networks.
• Market Expansion and Biosimilars: Future growth is expected as biosimilar manufacturers enter the market, potentially increasing supplier diversity.
• Resilience Strategies: Stakeholders should establish diversified supplier relationships, monitor regulatory developments, and consider regional manufacturing options to ensure supply security.

FAQs

1. Who are the primary API manufacturers for anidulafungin?
The key API suppliers include Fujifilm Toyama Chemical and licensed CMOs like Lonza and WuXi AppTec, leveraging fermentation technologies close to Pfizer’s original synthesis processes.

2. Are there regional differences in anidulafungin sourcing?
Yes. Asia-Pacific regions often rely on local manufacturing or licensed generics, while North America and Europe primarily depend on Pfizer and licensed suppliers.

3. What factors influence the supply stability of anidulafungin?
Manufacturing complexity, raw material availability, regulatory approvals, patent licensing agreements, and pandemic-related disruptions primarily impact supply stability.

4. Is there potential for new suppliers to enter the anidulafungin market?
Potentially. Biosimilar development, capacity upgrades, and regional manufacturing expansions could introduce new suppliers over the coming years.

5. How can healthcare providers ensure a reliable supply of anidulafungin?
Diversifying procurement sources, engaging with multiple licensed distributors, and establishing regional manufacturing partnerships are effective strategies.

Conclusion

The supply chain for anidulafungin remains notably concentrated within a few specialized manufacturers, driven by the molecule's synthesis complexity. While current supply appears stable, inherent risks necessitate strategic sourcing and supply chain resilience planning. As the antifungal market evolves, increased participation of biosimilars and regional manufacturers may diversify the supply landscape, offering increased security and potential cost benefits for healthcare stakeholders.

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Sources
[1] Pfizer Inc. Anidulafungin product information and approval documentation.
[2] Global Data. Market Reports on Antifungal Drugs.
[3] Reuters. Pharmaceutical manufacturing capacities and regional updates.
[4] Fujifilm. Corporate website and antifungal API details.
[5] WuXi AppTec. Manufacturing capabilities overview.