Bulk Pharmaceutical API Sources for FIBRICOR

Bulk Pharmaceutical API Sources for FIBRICOR

Vendor	Vendor Homepage	Vendor Sku	API Url
R&D Chemicals		56622
Tyger Scientific		C18081
ISpharm		I01-2052
MolPort		MolPort-000-002-475
MolPort		MolPort-006-393-282
ABI Chem		AC1L228K
ChemMol		30114608

Bulk Active Pharmaceutical Ingredient (API) Sources for: FIBRICOR

Last updated: July 28, 2025

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Introduction

FIBRICOR, the brand name for fenofibrate, is a widely used lipid-modifying agent prescribed to manage hyperlipidemia, particularly elevated triglycerides and low HDL cholesterol levels. As a key component in cardiovascular health management, the manufacturing quality and sourcing of its active pharmaceutical ingredient (API), fenofibrate, are critical for ensuring product efficacy, safety, and regulatory compliance. This article provides an in-depth analysis of the global API sourcing landscape for fenofibrate, highlighting primary manufacturers, geographical dynamics, quality considerations, and strategic procurement insights relevant to industry stakeholders.

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Market Overview of Fenofibrate API

Fenofibrate was first introduced in the 1970s and has since become a staple in lipid therapy, with a robust global demand. The API market’s growth correlates with increasing prevalence of metabolic syndrome and cardiovascular diseases. The API manufacturing sector is characterized by a combination of multinational pharmaceutical companies and a growing number of Chinese and Indian API producers, offering competitive pricing and varying quality standards.

Large pharmaceutical companies often maintain in-house or exclusive sourcing agreements with reputable API manufacturers to ensure quality control. Meanwhile, the proliferation of APIs produced in Southeast Asia’s emerging markets presents both opportunities and challenges regarding regulatory compliance and supply reliability.

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Key Global API Manufacturers for Fenofibrate

1. Daiichi Sankyo Co., Ltd.

Daiichi Sankyo is the originator of the brand FIBRICOR and maintains a vertically integrated supply chain for fenofibrate. Its manufacturing facilities are located predominantly in Japan, ensuring high-quality standards aligned with Good Manufacturing Practice (GMP). The company supplies the intermediates and finished API directly for its formulations, maintaining tight quality and regulatory compliance.

2. Zhejiang Kangle Pharmaceutical Co., Ltd. (China)

A prominent Chinese API producer, Zhejiang Kangle Pharmaceutical, supplies fenofibrate to global markets. The company has achieved GMP certification from Chinese authorities and has been expanding its export footprint. Its production facilities are equipped with modern synthesis technology, ensuring consistent API quality conforming to FDA and EMA standards.

3. Zhejiang Huikang Pharmaceutical Co., Ltd. (China)

Another leading Chinese manufacturer, Zhejiang Huikang Pharmaceutical, produces fenofibrate API for both domestic and international markets. The company has obtained ISO certifications and is working towards further regulatory approvals to penetrate North American and European markets.

4. Zhejiang Yourui Pharmaceutical Co., Ltd. (China)

Specialized in lipid-modifying agents, Zhejiang Yourui offers fenofibrate API with a focus on cost competitiveness. The company adheres to GMP standards, with many of its products approved for export to North America, Europe, and Asia.

5. Guangzhou Hanfang Pharmaceutical Co., Ltd. (China)

Focusing on generic APIs, Guangzhou Hanfang supplies fenofibrate API to numerous generic drug manufacturers worldwide. The company emphasizes quality through rigorous testing and compliance with international standards.

6. Other Notable Mention:

• Wuhan East Lake Biological & Pharmaceutical Co., Ltd. (China)
• APIs sourced from Indian manufacturers such as Jubilant Life Sciences and Orchid Pharmalabs.

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Regional Dynamics and Their Implications

China as a Leading API Source

China dominates the fenofibrate API market, accounting for approximately 60–70% of global production capacity. Chinese manufacturers benefit from lower manufacturing costs, large-scale synthesis capabilities, and government incentives that foster rapid capacity expansion. However, regulatory scrutiny from agencies like the FDA and EMA has increased, prompting some companies to pursue improved compliance measures, including international GMP certifications and third-party audits.

India’s Growing Market Share

India plays an increasingly significant role, driven by its well-established pharmaceutical industry, capable of producing high-quality APIs at competitive prices. Indian firms such as Jubilant Pharmova and Orchid Pharma have achieved certifications from global regulators, boosting their export credibility.

North American and European Sources

While fewer in number, some North American and European companies maintain API manufacturing facilities that comply with rigorous regulatory standards. These sources are preferred for high-quality, compliant APIs, often utilized by reputable pharmaceutical companies seeking to minimize regulatory risk.

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Quality and Regulatory Considerations

Procuring fenofibrate API requires rigorous assessment of quality attributes and regulatory compliance status:

• GMP Certification: Ensures the API is manufactured under international quality standards. Leading Chinese and Indian manufacturers have sought and obtained GMP certification from their respective regulatory agencies, easing export approvals.

• Analytical Data and Certificates of Analysis (COA): Validating purity (>99%), residual solvents, and impurity profile is essential.

• Regulatory Approvals: APIs with approved Drug Master Files (DMFs) or Abbreviated New Drug Applications (ANDAs) streamline registration processes.

• Manufacturing Track Record: Companies with a history of consistent quality and supply reliability mitigate risks associated with shortages or quality issues.

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Supply Chain Strategies and Procurement Insights

To mitigate supply disruptions and maintain quality standards, stakeholders should:

• Diversify supplier base across reputable manufacturers from different regions.
• Prioritize API sources with established regulatory approval statuses.
• Conduct periodic audits and quality assessments.
• Engage in long-term supply agreements with known manufacturers to ensure price stability and priority during shortages.
• Monitor geopolitical and regulatory developments impacting API manufacturing hubs.

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Emerging Trends and Future Outlook

The API supply landscape for fenofibrate is evolving amidst stricter regulatory standards, ongoing capacity expansions, and technological advances:

• Technology Integration: Use of continuous manufacturing processes improves scalability and quality control.
• Regulatory Harmonization: Efforts by ICH initiatives improve API consistency across markets.
• Sustainability Practices: Increasing focus on environmentally sustainable manufacturing to align with global regulatory expectations.
• COVID-19 Impact: Disrupted supply chains initially, but recovery and capacity expansion are ongoing.

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Key Takeaways

• Chinese manufacturers dominate the fenofibrate API market, offering cost-effective options, but require careful validation of regulatory compliance.
• Indian API producers are gaining prominence, supported by robust quality standards and regulatory approvals.
• High-quality APIs suitable for global markets must meet GMP standards and possess validated analytical data.
• Diverse and strategically managed supply chains mitigate risks associated with geopolitical uncertainties and regulatory changes.
• Staying abreast of technological innovations and regulatory developments enhances procurement agility and product quality.

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FAQs

1. What are the main factors to consider when sourcing fenofibrate API?
Quality standards (GMP compliance), regulatory approval status, supplier reliability, analytical validation data, and supply chain stability are critical factors to ensure efficacy and compliance.

2. How do Chinese fenofibrate API manufacturers compare to Indian counterparts?
Chinese manufacturers often offer lower costs and larger capacities, but Indian producers tend to have rigorous international certifications, aligning better with stringent regulatory standards like those of the FDA and EMA.

3. Are there any concerns regarding the quality of fenofibrate APIs from emerging markets?
While many emerging market APIs meet international standards, diligence through audits, certifications, and analytical validation is essential to mitigate potential quality variances.

4. What impact has regulatory scrutiny had on fenofibrate API sourcing?
Enhanced regulatory oversight prompts manufacturers to upgrade facilities, certifications, and quality systems, which may affect supply availability and pricing but ultimately improve product safety and consistency.

5. What future trends should procurement managers monitor?
Advancements in manufacturing technology, regulatory harmonization, sustainability initiatives, and geopolitical developments are influential trends shaping the fenofibrate API supply landscape.

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References

1. [1] Fit For The Future: The Changing Landscape of API Manufacturing, PharmSource, 2022.
2. [2] Global API Market Analysis, IQVIA, 2021.
3. [3] Regulatory Standards in API Manufacturing, World Health Organization, 2021.
4. [4] Chinese API Industry Overview, Chinese Pharmacopoeia, 2022.
5. [5] Indian API Market Trends, Indian Pharmaceutical Association, 2022.

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