Suppliers and packagers for generic pharmaceutical drug: REZAFUNGIN ACETATE

REZAFUNGIN ACETATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mundipharma	REZZAYO	rezafungin acetate	POWDER;INTRAVENOUS	217417	NDA	Melinta Therapeutics, LLC	70842-240-01	1 VIAL in 1 CARTON (70842-240-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL	2023-06-09

Suppliers for the Pharmaceutical Drug: Rezafungin Acetate

Last updated: July 27, 2025

Introduction

Rezafungin Acetate is a novel, once-weekly echinocandin antifungal agent developed for the treatment of invasive fungal infections, notably candidiasis and aspergillosis. As the pharmaceutical industry advances, securing a reliable supply chain for Rezafungin Acetate is critical for manufacturers, healthcare providers, and stakeholders aiming to address rising fungal infection cases amid increasing drug resistance. This report examines potential suppliers, their roles, and the strategic considerations involved in sourcing Rezafungin Acetate.

Overview of Rezafungin Acetate

Rezafungin is a broader-spectrum echinocandin that inhibits fungal cell wall synthesis by targeting β-(1,3)-D-glucan synthase. Its stability, prolonged half-life, and favorable pharmacokinetics distinguish it from existing antifungals such as caspofungin, anidulafungin, and micafungin. Currently undergoing clinical trials, Rezafungin’s commercial availability depends on successful regulatory approval and establishing a robust supply chain (Vesicorp Ltd, 2021).

Manufacturers of Active Pharmaceutical Ingredient (API)

The primary suppliers for Rezafungin Acetate are pharmaceutical companies that develop and manufacture APIs through complex chemical synthesis. The key considerations include capacity, quality standards, compliance with Good Manufacturing Practices (GMP), and proven track records.

1. U.S.-Based and Global Contract Manufacturing Organizations (CMOs)

Major CMOs play a vital role in API production, especially for complex molecules like Rezafungin. These organizations leverage extensive expertise, facilities, and regulatory compliance frameworks to produce high-quality APIs at scale.

• Thermo Fisher Scientific: As a leader in bioprocessing and pharmaceutical manufacturing, Thermo Fisher offers custom synthesis services. While primarily focused on biologicals, Thermo Fisher's API manufacturing capabilities extend to complex small molecules suitable for antifungal compounds. Their global footprint ensures supply stability aligned with international standards.

• Lonza: A Swiss-based manufacturing firm renowned for complex chemical and biopharmaceuticals. Lonza offers custom synthesis of APIs with high purity and GMP compliance. Their global facilities include operations in the U.S., Switzerland, and China.

• CordenPharma: Specializing in complex small-molecule APIs, CordenPharma provides custom synthesis and manufacturing with GMP accreditation, crucial for antifungal agents requiring high purity standards.

2. Asia-Based API Suppliers

Asia remains a dominant hub for pharmaceutical API manufacturing owing to cost efficiency and expanding manufacturing capacity.

• Fudan University’s API Manufacturing Unit (Shanghai, China): Known for advanced chemical synthesis capabilities, this unit produces various antifungal APIs. Such academic-industry collaborations may facilitate initial supply, but regulatory due diligence is vital for pharmaceutical applications.

• China-based Jiangsu Hengrui Medicine Co., Ltd.: An established pharmaceutical firm with robust API synthesis capabilities in antifungal and antimicrobial agents. Hengrui has scaled up production for multiple complex molecules and maintains strong compliance credentials.

• Shanghai Pharmaceuticals Holding Co., Ltd.: Offers API development and manufacturing, including specialty antifungal agents, with GMP certification aligned with international standards.

Downstream Supply Chain and Excipients

While the API form of Rezafungin Acetate is critical, formulation and excipient suppliers influence the final pharmaceutical product's quality, stability, and bioavailability. Notable excipient suppliers include:

• Pronacta (India): Supplies pharmaceutical-grade excipients utilized in injectable formulations.

• JRS Pharma (Germany): A provider of stabilizers and carriers for injectable antifungal drugs.

Regulatory and Quality Considerations

Any supplier involved must meet stringent GMP standards aligned with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Regulatory agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and China Food and Drug Administration (CFDA) require rigorous audits, documentation, and quality testing before approval.

Strategic Sourcing Considerations

• Capacity and Scalability: Developers need a supplier with the capacity to meet projected demand growth, accounting for potential outbreaks of invasive fungal infections.

• Geographical Diversification: To mitigate geopolitical and pandemic-related disruptions, engaging multiple suppliers across regions ensures continued supply.

• Quality Assurance: Prequalification and audit of manufacturing facilities ensure compliance with international standards, reducing regulatory hurdles.

• Intellectual Property and Licensing Agreements: Given Rezafungin’s proprietary nature, establishing licensing or partnership arrangements with developers or patent holders (e.g., Cidara Therapeutics) is necessary.

Conclusion

The supply landscape for Rezafungin Acetate involves a mixture of specialized contract manufacturers, established chemical synthesis firms, and regional producers capable of GMP-compliant API production. Key players include global CMOs such as Lonza and CordenPharma, and regional Asian manufacturers like Jiangsu Hengrui Medicine and Shanghai Pharmaceuticals. Ensuring supply stability demands strategic partnerships, rigorous quality oversight, and diversified sourcing.

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Key Takeaways

• Rezafungin Acetate’s successful market introduction hinges on securing reliable API suppliers with proven GMP compliance, adequate capacity, and high-quality standards.
• Top-tier global CMOs such as Lonza and CordenPharma are prime candidates for manufacturing complex antifungal APIs.
• Asian pharmaceutical manufacturers offer scalable and cost-effective options but require thorough regulatory vetting.
• Incorporating multiple suppliers and regional diversification isolates risks associated with geopolitical instability or supply chain disruptions.
• Strategic licensing agreements with patent holders or developers accelerate access while ensuring adherence to intellectual property rights.

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FAQs

1. When is Rezafungin Acetate expected to reach the market?
Rezafungin has completed Phase 3 clinical trials, with regulatory submissions underway in select regions. Its commercial launch is anticipated within the next 12 to 24 months once regulatory approvals are secured.

2. Which companies are currently involved in Rezafungin’s development and manufacturing?
Cidara Therapeutics originally developed Rezafungin, partnering with manufacturing firms like Fujifilm Diosynth Biotechnologies for active ingredient synthesis and formulation. Future large-scale manufacturing may involve additional CMOs.

3. What are the main challenges in sourcing Rezafungin Acetate?
Challenges include complex synthesis requiring high purity, stringent regulatory compliance, limited number of specialized manufacturers, and ensuring supply chain resilience amid COVID-19-related disruptions.

4. How do regulatory standards impact supplier selection?
Suppliers must comply with GMP, adhere to ICH guidelines, and have validated quality management systems. Regulatory audits and certifications are prerequisites before engagement.

5. Will geopolitical factors affect the global supply of Rezafungin API?
Potentially, yes. Geographic concentration of manufacturing in regions like China or India introduces risks. Diversification and multi-regional sourcing strategies are essential for supply security.

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References

[1] Vesicorp Ltd. (2021). Rezafungin: Clinical Development and Market Potential.
[2] Cidara Therapeutics. (2021). Rezafungin Clinical Trial Data and Development Pipeline.
[3] GMP Regulations and Guidelines. (2022). International Conference on Harmonisation (ICH).