Bulk Pharmaceutical API Sources for brincidofovir

Bulk Pharmaceutical API Sources for brincidofovir

Vendor	Vendor Homepage	Vendor Sku	API Url
ABI Chem		AC1LA8GF
Race Chemical		RV022503688
AK Scientific, Inc. (AKSCI)		Y1766
ZINC		ZINC14141521
ApexBio Technology		B1089
DC Chemicals		DC7761
Chemieliva Pharmaceutical Co., Ltd		PBCM0580615

Bulk Active Pharmaceutical Ingredient (API) Sources for: Brincidofovir

Last updated: July 30, 2025

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Introduction

Brincidofovir (also known by its developmental code, CMX001) is an investigational antiviral agent developed primarily for the treatment and prophylaxis of viral infections, including cytomegalovirus (CMV), adenovirus, and smallpox. As a lipid conjugate of cidofovir, brincidofovir exhibits improved oral bioavailability and subcellular distribution, making it a promising candidate in antiviral therapy. Its manufacturing requires a reliable, high-quality supply of Active Pharmaceutical Ingredient (API), which is critical for clinical development, commercialization, and global access.

This article provides a comprehensive overview of the sources for bulk brincidofovir API, focusing on the landscape of suppliers, manufacturing processes, quality standards, and regulatory considerations to inform stakeholders in pharmaceutical development and supply chain management.

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Overview of API Manufacturing for Brincidofovir

Brincidofovir synthesis involves complex organic chemistry, primarily focusing on the conjugation of cidofovir with lipid moieties—specifically, 1-O-hexadecyl dibutyl glycerol phosphonoadenosine derivatives. The process demands strict control of chemical reactions, purification steps, and adherence to Good Manufacturing Practices (GMP).

Because brincidofovir is still in clinical development or limited commercialization phases, sourcing strategies often focus on contract manufacturing organizations (CMOs) with specialized expertise in nucleoside analogs, lipid conjugates, and complex APIs.

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Key Criteria for API Suppliers

When selecting a supplier for brincidofovir API, the following criteria are paramount:

• Regulatory compliance: GMP certification and adherence to the International Conference on Harmonisation (ICH) guidelines.
• Manufacturing capacity: Ability to scale production from pilot to commercial scales.
• Quality assurance: Robust analytical and quality control procedures, including stability data.
• Experience: Proven track record in producing complex nucleoside and lipid conjugate APIs.
• Supply reliability: Consistent, on-time delivery with contingency planning.

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Major API Suppliers for Brincidofovir

1. Contract Manufacturing Organizations (CMOs)

Most current brincidofovir APIs are supplied by specialized CMOs. Due to the compound’s complexity, pharma companies typically partner with firms experienced in nucleoside analogs and lipid conjugates.

a. WuXi AppTec

• Overview: WuXi AppTec is a leading CMO with extensive experience in complex API synthesis.
• Capabilities: They possess advanced facilities for nucleoside synthesis, lipid chemistry, and GMP production.
• Strengths: Their integrated process development supports large-scale manufacturing with quality assurance.

b. Samsung Biologics / Daewoong Pharmaceutical

• Overview: These biopharmaceutical and chemical manufacturers offer API development and manufacturing, including for lipid-conjugated compounds.
• Capabilities: Capable of scalable GMP production for complex small molecules like brincidofovir.
• Strengths: Proven track record in antiviral APIs with robust regulatory documentation.

c. Fujifilm Diosynth Biotechnologies

• Overview: While primarily focused on biologics, Fujifilm also specializes in complex chemical APIs and conjugates.
• Capabilities: Custom synthesis and process optimization for lipid-based compounds.
• Strengths: State-of-the-art manufacturing facilities compatible with GMP standards.

d. Lonza

• Overview: Lonza's extensive API manufacturing services include nucleoside analogs.
• Capabilities: Access to large-scale GMP API synthesis with strict regulatory oversight.
• Strengths: Established quality systems and global supply network.

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2. Specialized Chemical Suppliers

Direct procurement from chemical suppliers is uncommon for APIs at clinical or commercial scale but may occur during early phases or for research purposes.

a. Carbosynth

• Focused on high-purity building blocks relevant to nucleoside and lipid chemistry.
• Provides intermediates and custom synthesis services, which may be adapted into full APIs.

b. TCI Chemicals / Sigma-Aldrich

• Offer specialized reagents and intermediates but are not primary providers of finished APIs.
• Suitable for research and early development phases.

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Emerging and Regional API Sources

As the demand for brincidofovir grows, regional manufacturers in Asia and Europe are expanding their capabilities.

• China: Several local API manufacturers have developed expertise in nucleoside analogs, offering competitive pricing and scalable GMP options.
• India: Known for cost-effective synthesis, several Indian CMOs possess the capacity for complex API manufacturing, often certified by global regulatory agencies.

However, validation of quality standards and regulatory compliance remains critical when selecting emerging suppliers.

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Regulatory and Quality Considerations

Establishing a reliable API supply chain for brincidofovir requires adherence to ICH Q7 guidelines on Good Manufacturing Practice for Active Pharmaceutical Ingredients. Suppliers must provide comprehensive documentation, including:

• Batch records and Certificates of Analysis (CoA)
• Stability data
• Process validation reports
• Regulatory filings (DMF or CEP submissions)

Due to the investigational status, regulatory agencies may require detailed white papers on the synthesis route, impurities profile, and residual solvent data.

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Conclusion and Future Outlook

The sourcing of brincidofovir API hinges on partnerships with specialized CMOs capable of complex lipid-conjugate synthesis under GMP conditions. Leading global players like WuXi AppTec, Lonza, and Fujifilm Diosynth are currently positioned to serve the need for high-quality API supply.

As brincidofovir advances toward commercialization or expanded clinical trials, supplier capacity, quality assurance, and regulatory compliance will be essential criteria. The evolving landscape promises increased regional manufacturing options, which could compromise costs and accelerate access, provided quality standards are maintained.

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Key Takeaways

• Specialized partnerships: Due to the complexity of brincidofovir synthesis, reliance on experienced CMOs rather than generic suppliers is essential.
• Regulatory compliance: Ensuring GMP-certified sources with comprehensive documentation supports smooth regulatory approval processes.
• Regional growth: Emerging Asian and European manufacturers are expanding capabilities, offering cost advantages with appropriate validation.
• Supply chain resilience: Multiple supplier relationships mitigate risks of shortages in complex API manufacturing.
• Future scalability: Collaborations should consider potential scale-up requirements aligned with clinical and commercial needs.

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FAQs

1. What are the primary challenges in sourcing brincidofovir API?
The complex lipid conjugation chemistry and strict quality standards pose challenges, requiring highly specialized manufacturing processes and rigorous regulatory compliance.

2. Are there any approved commercial sources for brincidofovir API?
As of 2023, brincidofovir remains investigational. Most API sourcing occurs within clinical trial phases under GMP-certified CMOs.

3. How does regional manufacturing impact API quality and cost?
Regional manufacturing, particularly in Asia, can lower costs but necessitates rigorous validation and quality control to meet global regulatory standards.

4. Can intermediates be sourced separately for custom synthesis?
Yes, high-purity intermediates, including nucleoside analogs and lipid-building blocks, are available from specialized chemical suppliers, aiding in custom synthesis.

5. What regulatory factors influence API sourcing for brincidofovir?
Manufacturers must comply with ICH GxP standards, provide comprehensive documentation, and align with the evolving regulatory landscape for antiviral APIs.

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References

[1] U.S. Food and Drug Administration. Brincidofovir (CMX001) Clinical Trials.
[2] EMA Scientific Advice. Complex API Manufacturing Guidelines.
[3] WuXi AppTec. API Development and Manufacturing Capabilities.
[4] Lonza. Complex Nucleoside API Production.
[5] ICH Q7. Guidelines for Good Manufacturing Practice for Active Pharmaceutical Ingredients.

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(Note: Specific supplier names, capabilities, and project statuses may evolve; always verify current operational details and regulatory compliance before engagement.)