Bulk Pharmaceutical API Sources for FENOFIBRATE

Bulk Pharmaceutical API Sources for FENOFIBRATE

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		F6020_SIGMA
Molport		MolPort-002-887-051
Hangzhou APIChem Technology		AC-4227
AKos Consulting & Solutions		AKOS005107777

Bulk Active Pharmaceutical Ingredient (API) Sources for Fenofibrate

Last updated: July 27, 2025

Introduction

Fenofibrate, a lipid-lowering agent primarily used to treat hyperlipidemia and prevent cardiovascular disease, is a widely manufactured pharmaceutical compound. Its pharmaceutical efficacy stems from its ability to activate peroxisome proliferator-activated receptor-alpha (PPAR-α), leading to increased lipolysis and elimination of triglyceride-rich particles in plasma. The integrity of its supply chain hinges on sourcing high-quality bulk active pharmaceutical ingredients (APIs). This article explores the global landscape of Fenofibrate API manufacturing, highlighting key suppliers, geographical distribution, quality standards, and sourcing considerations.

Global Manufacturing of Fenofibrate API

The production of Fenofibrate API involves multi-step chemical synthesis requiring rigorous process controls and quality assurance. The manufacturing landscape is concentrated among several prominent players capable of adhering to pharmaceutical-grade standards, notably Good Manufacturing Practices (GMP) certification.

Leading API Manufacturers

1. China

China remains the dominant supplier of Fenofibrate API globally. Its manufacturing sector offers cost advantages and has a well-established biochemical manufacturing infrastructure. Major Chinese API producers, such as Zhejiang Medicine Co., Ltd., Zhejiang Huahai Pharmaceutical Co., Ltd., and Zhejiang Hisun Pharmaceutical Co., Ltd., have received GMP certifications and export to global markets including North America, Europe, and Asia.

2. India

India is another significant source, with companies like Sun Pharma, Aurobindo Pharma, and Cipla producing Fenofibrate API at scale. Indian manufacturers benefit from robust pharmaceutical R&D capabilities and global regulatory acceptance, although quality verification remains essential for procurement.

3. Europe and the United States

While the U.S. and European API producers represent a smaller segment of Fenofibrate manufacturing, they are noted for their rigorous quality standards. Companies such as BASF and Solara Active Pharma Sciences manufacture high-grade APIs conforming to stringent GMP and regulatory requirements, catering primarily to the North American and European markets.

Quality and Regulatory Standards

Quality assurance in Fenofibrate API sourcing involves adherence to the following standards:

• GMP Certification: Critical for manufacturing pharmaceutical-grade API.
• Pharmacopoeial Compliance: APIs should conform to United States Pharmacopeia (USP), European Pharmacopoeia (EP), or other recognized pharmacopoeias.
• Certifications and Audits: Suppliers with certifications like ISO 9001/ISO 14001, and successful audit reports bolster credibility.

Key API Suppliers for Fenofibrate

Supplier Name	Location	Certification & Standards	Production Capacity	Distribution Focus
Zhejiang Medicine Co., Ltd.	China	GMP, ISO 9001, ISO 14001	Large	Global, Asia, North America
Zhejiang Huahai Pharmaceutical	China	GMP, CNAS Certification	Large	Global
Zhejiang Hisun Pharmaceutical	China	GMP, ISO Certification	Moderate to large	Asia, North America, Europe
Sun Pharma	India	GMP, FDA Approved, USDMF (United States Drug Master File)	Large	North America, Europe
Aurobindo Pharma	India	GMP, USDMF, European Certification	Large	Global
BASF	Germany	GMP, ISO 9001, ISO 14001	Medium	Global (Premium API Market)
Solara Active Pharma Sciences	India	GMP, USDMF, EUGMP certifications	Medium	North America, Europe

Sourcing Considerations

1. Quality and Regulatory Compliance

Procurement quality is paramount; APIs sourced from suppliers with stringent GMP adherence and pharmacopoeial compliance mitigate risks of substandard materials.

2. Cost and Lead Times

Chinese suppliers typically offer competitive pricing but may have longer shipping lead times due to logistical complexities. Indian suppliers provide a balanced mix of quality, cost, and delivery speed. European and U.S. sources tend to command premium pricing but ensure superior compliance standards.

3. Supply Chain Security

Diversification among multiple suppliers reduces vulnerability. Establishing long-term relationships with reputable manufacturers ensures consistency, regulatory compliance, and traceability.

4. Raw Material Control

The quality of Fenofibrate API depends on precursor purity. Suppliers controlling the entire supply chain from raw materials to final API enhance quality assurance.

Emerging Trends in API Sourcing

1. Contract Manufacturing and Outsourcing

Pharmaceutical companies increasingly outsource Fenofibrate API manufacturing through Contract Manufacturing Organizations (CMOs). This approach offers flexibility and scalability but necessitates thorough due diligence.

2. Shift Toward High-Quality, Transparent Suppliers

Regulatory agencies like the FDA and EMA emphasize supply chain transparency. Suppliers demonstrating compliance, audit readiness, and quality certifications are favored.

3. Focus on Sustainability and Green Chemistry

Sustainable manufacturing practices are gaining importance, with suppliers adopting eco-friendly processes that reduce environmental impact, aligning with global regulatory shifts.

Regulatory Dynamics and Future Outlook

The evolving global regulatory landscape continues to influence API sourcing. Increased scrutiny on purity and traceability standards compels suppliers to enhance quality management systems. Notably, the COVID-19 pandemic underscored the importance of supply chain resilience, prompting pharmaceutical firms to diversify sourcing strategies and consider emerging markets.

Looking ahead, the API manufacturing sector for Fenofibrate is expected to consolidate around high-quality, compliant sources with a focus on sustainability and supply chain transparency. Chinese and Indian suppliers will likely maintain dominant positions, with European and U.S. firms emphasizing regulatory compliance and traceability.

Key Takeaways

• China and India dominate the Fenofibrate API market, providing cost-effective, large-scale manufacturing capacity.
• European and U.S. suppliers prioritize regulatory compliance and high purity standards.
• Sourcing decisions should weigh factors including quality certifications, supply chain resilience, cost, and regulatory acceptance.
• Diversification among reputable suppliers minimizes risks linked to supply disruptions and quality lapses.
• The sector is moving toward greener, more transparent manufacturing practices, driven by regulatory and market demands.

FAQs

1. How can I verify the quality of Fenofibrate API from Chinese manufacturers?
Verify GMP certification, request WHO-GMP or PIC/S certifications, and demand reference audits or Third-Party QA reports. Additional testing upon receipt ensures compliance with pharmacopoeial standards.

2. Are Indian Fenofibrate APIs compliant with U.S. FDA regulations?
Many Indian suppliers like Sun Pharma and Aurobindo Pharma maintain USDMF registrations, making their APIs compliant with U.S. regulatory requirements when sourced from approved facilities.

3. What are the risks of sourcing Fenofibrate API from low-cost suppliers?
Risks include substandard purity, inconsistent supply, lack of regulatory compliance, counterfeit products, and potential regulatory sanctions.

4. How does supply chain diversification influence API sourcing strategy?
It enhances security, reduces dependency on single sources, mitigates geopolitical risks, and ensures consistent supply continuity.

5. What future developments could impact Fenofibrate API sourcing?
Implementation of stricter global quality standards, increased emphasis on sustainability, digital traceability measures, and geopolitical trade shifts will influence sourcing strategies.

---

References

[1] Statista. (2022). Global API production data.
[2] World Health Organization. (2021). Highlights of the WHO Prequalification Programme.
[3] U.S. Food and Drug Administration. (2022). Drug master files and API quality standards.
[4] Fitch Solutions. (2023). Global API manufacturing outlook.
[5] Deloitte. (2022). Pharma supply chain resilience report.