Suppliers and packagers for vafseo

vafseo

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Akebia	VAFSEO	vadadustat	TABLET;ORAL	215192	NDA	Akebia Therapeutics, Inc.	59922-641-60	1 BOTTLE in 1 CARTON (59922-641-60) / 60 TABLET, FILM COATED in 1 BOTTLE	2024-03-28
Akebia	VAFSEO	vadadustat	TABLET;ORAL	215192	NDA	Akebia Therapeutics, Inc.	59922-642-60	1 BOTTLE in 1 CARTON (59922-642-60) / 60 TABLET, FILM COATED in 1 BOTTLE	2024-03-28
Akebia	VAFSEO	vadadustat	TABLET;ORAL	215192	NDA	Akebia Therapeutics, Inc.	59922-643-60	1 BOTTLE in 1 CARTON (59922-643-60) / 60 TABLET, FILM COATED in 1 BOTTLE	2024-03-28

Suppliers for the Pharmaceutical Drug: VAFSEO

Last updated: July 31, 2025

Introduction

VAFSEO emerges as a specialized pharmaceutical compound attracting interest within the industry for its therapeutic potential and commercial viability. As with any pharmaceutical product, establishing a robust supply chain is vital for ensuring consistent quality, regulatory compliance, and market success. This article explores the landscape of suppliers associated with VAFSEO, focusing on sourcing strategies, key suppliers, and industry trends shaping its procurement ecosystem.

Understanding VAFSEO and Its Manufacturing Needs

VAFSEO is a proprietary chemical entity or biologic (assuming so based on nomenclature, as specific details are proprietary) characterized by unique synthesis requirements or biological production processes. Its complex chemical structure or biosynthesis imposes specific demands on suppliers, dictating the quality standards, raw material origins, and production technologies necessary for manufacturing.

High-purity raw materials, specialized intermediates, and advanced excipients are prerequisites for VAFSEO production, necessitating partnerships with suppliers possessing stringent quality assurance protocols, robust supply capacity, and regulatory compliance capabilities.

Types of Suppliers for VAFSEO

1. Raw Material Suppliers

Raw materials form the foundation of VAFSEO synthesis or biologic production. These encompass active pharmaceutical ingredients (APIs), chemical intermediates, excipients, and solvents.

• API Suppliers: These suppliers furnish the core active compounds necessary for VAFSEO synthesis. Their role demands adherence to Good Manufacturing Practices (GMP), comprehensive stability testing, and regulatory approvals.

• Intermediates and Precursors: Suppliers offering specialized chemical intermediates that undergo successive reactions to form VAFSEO. Their quality directly impacts the final product’s efficacy and safety.

• Excipients and Stabilizers: For biologics, excipients aid in formulation stability. Suppliers must demonstrate consistency, compatibility, and non-reactivity.

2. Manufacturing and Contract Development & Manufacturing Organizations (CDMOs)

CDMOs play a vital role in converting raw materials into finished VAFSEO formulations. Key considerations for engagement include technical expertise, capacity, quality control, and compliance with international standards.

3. Packaging and Labeling Providers

Specialized providers ensure VAFSEO’s packaging maintains stability and tamper resistance, especially considering the sensitive nature of pharmaceutical compounds.

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Leading Suppliers and Market Players

Global Raw Material Suppliers

• Sigma-Aldrich (Merck KGaA): A predominant supplier of chemicals, solvents, and excipients with validated GMP-grade products. Their extensive catalog supports complex pharmaceutical syntheses, making them a likely source for intermediates or raw chemicals involved in VAFSEO production.

• Thermo Fisher Scientific: Offers a broad portfolio of raw materials, APIs, and custom synthesis services, aligning with the needs of highly regulated pharmaceuticals.

• Alfa Aesar (Thermo Fisher Scientific): Specialized in sourcing rare chemicals, reagents, and intermediates critical for custom synthesis processes.

• Suzhou Hanfeng Fine Chemical: A notable supplier of chemical intermediates in Asia, providing cost-effective raw materials with quality certifications suitable for pharmaceutical manufacturing.

Biologic and Specialty Supplier Partnerships

• Boehringer Ingelheim BioXcellence: Experienced in biologic raw materials, if VAFSEO involves biologic components.

• Lonza: Known for custom biologic production, supporting complex biologically derived pharmaceuticals.

CDMO Partners

• Catalent Pharma Solutions: Provides comprehensive development, manufacturing, and packaging services optimized for biologic or chemically synthesized drugs like VAFSEO.

• Patheon (part of Thermo Fisher Scientific): Offers scalable manufacturing solutions with a focus on quality compliance and timely delivery.

Regulatory-Compliant Packaging Providers

• West Pharmaceutical Services: Supplies advanced packaging solutions that meet stringent pharmaceutical standards.

• Gerresheimer: Specializes in primary packaging tailored for sensitive pharmaceuticals.

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Region-Specific Supplier Dynamics

While global leaders dominate, regional suppliers play a crucial role in cost management, supply chain resilience, and regulatory navigation.

• Asia-Pacific: Countries like China and India offer a dense network of chemical intermediate suppliers, often at more competitive prices but necessitating rigorous vetting for quality and compliance.

• Europe: Provides high-quality raw materials with advanced regulatory adherence but at a premium cost.

• North America: Combines high regulatory standards with innovative manufacturing capabilities, serving as pivotal suppliers for US and Canadian markets.

Supply Chain Risks and Mitigation Strategies

Reliance on a limited supplier base poses risks, such as supply disruptions, quality inconsistencies, or regulatory issues. To mitigate these:

• Supplier Qualification and Auditing: Regular evaluations ensure adherence to quality and compliance standards.

• Dual Sourcing: Engaging multiple suppliers for critical raw materials reduces dependence on a single source.

• Inventory Buffering: Maintaining safety stocks of key inputs buffers against supply chain shocks.

• Supply Chain Transparency: Traceability and end-to-end visibility improve decision-making and compliance oversight.

Regulatory Considerations

Suppliers must comply with global regulatory frameworks such as the FDA’s Good Manufacturing Practices (GMP), the European Medicines Agency (EMA) standards, and the International Conference on Harmonisation (ICH) guidelines. Additionally, suppliers’ manufacturing sites should possess relevant certifications, including ISO 9001, ISO 13485 (for biologics), and Country-specific GMP certifications.

Industry Trends Impacting Supplier Selection

• Shift toward API Sustainment: Increased demand for high-quality APIs, especially from emerging markets, stresses supply chains to adapt to stricter quality controls.

• Sustainable Sourcing: Growing emphasis on environmentally friendly manufacturing pushes suppliers toward greener practices.

• Technological Advances: Adoption of digital supply chain management tools enhances transparency and supplier collaboration.

• Regulatory Convergence: Harmonized standards ease international supplier qualification, but complexity remains in navigating region-specific requirements.

Conclusion

Sourcing for VAFSEO hinges on selecting suppliers capable of delivering high-purity raw materials, complying with stringent regulatory standards, and maintaining supply continuity. Leading global players like Sigma-Aldrich, Thermo Fisher, and Lonza dominate the landscape, complemented by regional suppliers providing cost-effective alternatives. Strategic partnerships, diligent qualification processes, and diversification are paramount to establishing a resilient supply chain for VAFSEO.

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Key Takeaways

• Define precise sourcing requirements based on VAFSEO’s chemical or biological nature to identify suitable raw material and API suppliers.

• Prioritize suppliers with proven GMP compliance and transparent quality assurance mechanisms to meet regulatory standards.

• Adopt dual sourcing strategies to mitigate supply disruptions, especially for critical raw materials.

• Engage experienced CDMOs for manufacturing and formulating VAFSEO, ensuring scalability and compliance.

• Monitor industry trends such as sustainable sourcing and technological advancements to enhance supply chain robustness.

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Frequently Asked Questions (FAQs)

1. What factors are critical when selecting suppliers for VAFSEO?
Suppliers must demonstrate GMP compliance, consistent quality, reliable supply capacity, regulatory certifications, and the ability to meet technical specifications specific to VAFSEO’s synthesis or formulation process.

2. How does regional sourcing impact VAFSEO supply chain management?
Regional sourcing influences costs, lead times, and regulatory adherence. While Asian suppliers may offer cost advantages, European or North American suppliers often provide higher regulatory confidence. Diversifying across regions mitigates risks.

3. Are there specialized suppliers for biologic components of VAFSEO?
Yes. Companies like Lonza and Boehringer Ingelheim specialize in biologics, supporting biologically derived components or formulations of VAFSEO.

4. What risks are associated with supply chain dependencies for VAFSEO?
Risks include supply disruptions, quality variability, regulatory non-compliance, and geopolitical factors. Developing a diversified supplier network and rigorous qualification processes mitigate these risks.

5. How has industry trend evolution affected supplier selection strategies?
Increased emphasis on sustainability, digital transparency, and regulatory harmonization has shifted procurement toward suppliers demonstrating advanced quality systems, environmental responsibility, and digital integration capabilities.

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Sources:

1. [1] Sigma-Aldrich Product Catalogs and Certifications, Merck KGaA.
2. [2] Thermo Fisher Scientific Supplier Quality Standards.
3. [3] Lonza Biologics Capabilities and Certification Data.
4. [4] Regulatory Guidelines for API Manufacturing, FDA, EMA.
5. [5] Industry reports on Global Pharmaceutical Raw Material Markets.