Bulk Pharmaceutical API Sources for FINACEA

Bulk Pharmaceutical API Sources for FINACEA

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		246379_ALDRICH
Sigma-Aldrich		A96150_ALDRICH
TCI (Tokyo Chemical Industry)		A0561

Bulk Active Pharmaceutical Ingredient (API) Sources for: Finacea

Last updated: July 30, 2025

Introduction

Finacea (azelaic acid) is a well-established topical medication primarily utilized for treating rosacea and acne vulgaris. Its active pharmaceutical ingredient (API), azelaic acid, exhibits antimicrobial, anti-inflammatory, and keratolytic properties. Due to its therapeutic prominence, procurement of high-quality bulk azelaic acid API remains critical for pharmaceutical manufacturers aiming to meet regulatory standards while ensuring efficacy and safety. This article delivers a comprehensive analysis of potential API sourcing options for azelaic acid, highlighting manufacturer profiles, geographic considerations, regulatory compliance, and supply chain factors vital for business decision-making within the pharmaceutical industry.

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Understanding Azelaic Acid as an API

Azelaic acid (C9H16O4) is a naturally occurring dicarboxylic acid, traditionally sourced from grains such as wheat, barley, and rye. Synthetic production methods dominate to meet global pharmaceutical demand, emphasizing purity, consistency, and regulatory adherence. The API's stability, bioavailability, and bioequivalence are integral to end-product quality assurance. As a specialty chemical, azelaic acid requires strict manufacturing oversight aligned with Good Manufacturing Practices (GMP), with suppliers typically holding certifications from agencies like the U.S. FDA, EMA, or other regulatory bodies.

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Global API Suppliers for Azelaic Acid

1. European and North American Manufacturers

• BASF SE (Germany):
  As a pioneer in specialty chemicals, BASF produces pharmaceutical-grade azelaic acid with rigorous GMP compliance. Their product portfolio features high-purity APIs suitable for pharmaceutical formulations. BASF emphasizes sustainability and regulatory adherence, making them a preferred supplier for global pharmaceutical companies.

• Bayer AG (Germany):
  Known for integrating chemical synthesis with pharma research, Bayer offers azelaic acid APIs targeting both dermatological and research applications. Their manufacturing complies with rigorous GMP standards, and their extensive distribution network supports reliable global supply.

• Croda International (UK):
  Croda supplies specialty chemicals including azelaic acid for pharmaceutical applications. Their APIs adhere to high purity standards, with a focus on quality assurance and regulatory compliance suitable for both topical drugs and research.

2. Asian API Producers

• Zhejiang Conversion Pharmaceutical Co., Ltd. (China):
  Specializing in the synthesis of bioactive chemicals, this Chinese producer offers azelaic acid APIs at competitive prices. They maintain GMP certifications and provide certificates of analysis (CoA) compliant with international standards. Their strategic proximity to raw material sources enables cost-effective production.

• Shandong Luoxin Pharmaceutical Group (China):
  A well-established pharmaceutical manufacturer with a diversified portfolio, including azelaic acid. Their API production facilities are certified according to GMP, with a focus on scaling supply for global export.

• Venus Ethylchem Pvt Ltd. (India):
  An emerging supplier offering high-grade pharmaceutical APIs, including azelaic acid. They emphasize quality control and offer flexible batch sizes to accommodate varying customer needs.

3. Emerging and Specialty API Manufacturers

• Evonik Industries (Germany):
  Specializes in specialty chemicals with a focus on pharmaceutical excipients and APIs. Their azelaic acid API manufacturing adheres to stringent compliance standards, supported by robust R&D capabilities for customized formulations.

• Shanghai Hanhong Chemical (China):
  Focuses on fine chemicals and APIs, providing azelaic acid sourced via sustainable synthetic routes. Their sourcing strategy emphasizes quality control and consistency for pharmaceutical applications.

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Sources and Procurement Considerations

Quality Assurance & Regulatory Compliance:
Sourcing from suppliers with clear GMP certifications, validated manufacturing processes, and transparent quality documentation is vital. Suppliers must provide CoAs, stability data, and batch validation reports aligning with international standards such as ICH Q7 and pharmacopoeia requirements.

Pricing Dynamics:
Pricing varies significantly based on manufacturing complexity, raw material costs, geographic location, and scale. Asian producers often offer cost advantages, but buyers must evaluate quality assurance protocols diligently.

Supply Chain Stability:
Long-term partnerships with reputable suppliers minimize risks related to shortages and regulatory audits. Suppliers with diversified manufacturing facilities and contingency plans are preferred to mitigate geopolitical or logistical disruptions.

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Regulatory Landscape and Market Access

The procurement of azelaic acid APIs must align with regional regulatory guidelines, including the U.S. FDA’s Drug Master Files (DMFs), EMA’s CEPs (Certificate of Suitability), and equivalent local certifications. Companies should verify that API suppliers hold valid regulatory authorizations and possess extensive documentation to support regulatory submissions and audits.

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Emerging Trends in API Sourcing

• Sustainable Manufacturing:
  Increasing emphasis on green chemistry encourages suppliers to adopt solvent reduction, resource efficiency, and eco-friendly synthetic pathways. Sustainability credentials influence procurement decisions.

• Vertical Integration:
  Vertically integrated suppliers offering both raw materials and APIs streamline quality control, reduce lead times, and optimize supply chain management.

• Digital Transparency:
  The integration of blockchain and digital tracking enhances traceability, builds trust, and simplifies regulatory validation processes.

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Conclusion

The sourcing of azelaic acid API for Finacea production demands a strategic approach balancing quality, regulatory compliance, cost, and supply security. Leading European firms like BASF and Bayer, alongside Asian manufacturers such as Zhejiang Conversion Pharmaceutical and Shandong Luoxin, offer diverse options tailored to different manufacturing needs. Their ability to meet stringent GMP standards and provide transparent quality documentation makes them suitable partners for pharmaceutical companies aiming to ensure consistent product efficacy. As the demand for dermatological treatments persists, maintaining resilient, compliant, and sustainable supply chains will be central to future success in azelaic acid API procurement.

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Key Takeaways

• Select suppliers with proven GMP compliance, recognized certifications, and transparent quality documentation to ensure API quality.
• Asian manufacturers offer competitive pricing, but rigorous quality and compliance verification remain pivotal.
• Long-term supplier relationships mitigate risks related to supply disruptions and regulatory audits.
• Embracing sustainability and digital transparency enhances supply chain resilience.
• Geographic sourcing strategies should align with regulatory jurisdictions and logistical considerations to optimize procurement efficiency.

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FAQs

1. What are the primary considerations when sourcing azelaic acid API for pharmaceutical manufacturing?
Regulatory compliance (GMP certification), API purity and stability, supplier reliability, quality documentation, and cost-effectiveness are crucial considerations.

2. Which regions dominate azelaic acid API production?
Europe and North America host established producers like BASF and Bayer, while China and India are prominent in supplying competitively priced APIs due to manufacturing scale and raw material access.

3. How does regulatory compliance influence API procurement decisions?
Regulatory standing ensures APIs meet safety, efficacy, and quality standards, reducing risk of product rejection and compliance issues during registration.

4. Are there sustainable options for sourcing azelaic acid APIs?
Yes. Increasingly, suppliers adopt green chemistry techniques, renewable raw materials, and sustainable production practices, which are becoming key data points for procurement.

5. What future trends are shaping azelaic acid API sourcing?
Emerging trends include digital supply chain transparency, enhanced sustainability, custom manufacturing, and increased focus on supply chain resilience amid geopolitical uncertainties.

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Sources

[1] European Pharmacopoeia, Azelaic Acid Monograph.
[2] International Conference on Harmonisation (ICH) Q7 Guidelines.
[3] Company websites and product datasheets of BASF, Bayer, Croda, Zhejiang Converison, and other named manufacturers.
[4] Industry reports on active pharmaceutical ingredient manufacturing and supply chain logistics.