Bulk Pharmaceutical API Sources for TRICOR (MICRONIZED)

Bulk Pharmaceutical API Sources for TRICOR (MICRONIZED)

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		F6020_SIGMA
Hangzhou Trylead Chemical Technology		TL8003296
NovoSeek		3339
ISpharm		I06-0048
MolPort		MolPort-002-887-051
Hangzhou APIChem Technology		AC-4227

Bulk Active Pharmaceutical Ingredient (API) Sources for: TRICOR (MICRONIZED)

Last updated: July 28, 2025

Introduction

Tricor, the brand name for fenofibrate, is a widely used lipid-lowering agent indicated primarily for managing hypertriglyceridemia and mixed dyslipidemia. The micronized formulation enhances bioavailability, making fenofibrate an effective medication in cardiovascular risk management. As the demand for Tricor and its generic equivalents rises globally, securing reliable sources for bulk active pharmaceutical ingredients (API), particularly micronized fenofibrate, remains critical for manufacturers and pharmaceutical supply chain stakeholders.

This analysis delineates the primary API sources for micronized fenofibrate, evaluates their market positioning, quality standards, and supply capabilities, and offers insights into sourcing strategies for pharmaceutical companies.

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Overview of Fenofibrate API Market

Fenofibrate is a fibric acid derivative that functions by activating peroxisome proliferator-activated receptors (PPARα), thus reducing triglycerides and enhancing HDL cholesterol levels. Its increasing prescribing trends have driven demand for high-quality API supplies, especially micronized formulations necessary for optimal bioavailability (source: [1]).

The global fenofibrate API market is segmented by geographical region, with dominant producers in North America, Europe, and Asia. Asian API manufacturers, notably in India and China, offer cost-effective production, with several ISO-certified facilities adhering to stringent quality standards.

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Key API Manufacturers for Micronized Fenofibrate

1. Zhejiang Huahai Pharmaceutical Co., Ltd. (China)

• Market Position: Among leading Chinese API producers, Zhejiang Huahai is recognized for high-quality manufacturing according to international standards, including GMP, FDA, and EMA approvals.
• Product Profile: Offers micronized fenofibrate suitable for pharmaceutical formulations, including sustained-release and generic products.
• Supply Capacity: Estimated to produce thousands of kilograms annually, benefiting from robust infrastructure.

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

• Market Position: Known for producing high-purity fenofibrate API with reliable supply chains.
• Quality Certifications: GMP-certified, with exports to Western markets.
• Product Scope: Supplies micronized and standard fenofibrate APIs tailored for high bioavailability formulations.

3. Jiangsu Hengrui Medicine Co., Ltd. (China)

• Market Position: Renowned for integrating R&D with manufacturing of APIs, including fenofibrate.
• Quality Assurance: Strict adherence to international standards, with regulatory approvals in major markets.
• Supply Capabilities: Capable of fulfilling large-volume orders, with consistency in quality.

4. Hetero Labs Limited (India)

• Market Position: Indian API manufacturer with a global footprint, Hetero is notable for its cost-effective API production.
• Certifications: GMP, ISO, USFDA approvals.
• Specialization: Provides micronized fenofibrate complying with pharmacopeial standards, suitable for formulations requiring enhanced bioavailability.

5. Laurus Labs (India)

• Market Position: Establishing itself as a major API supplier in the cardiovascular segment, including fenofibrate.
• Regulatory Compliance: GMP, USFDA, EMA-approved facilities.
• Supply Reliability: Known for consistent high-purity APIs and scalable production.

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Criteria for Selecting API Suppliers

1. Quality Assurance and Certification

Sourcing high-quality fenofibrate APIs necessitates suppliers with robust GMP certification, adherence to pharmacopeial standards (USP, EP, BP), and regulatory approvals (USFDA, EMA). These certifications ensure batch-to-batch consistency, impurity control, and compliance with global standards.

2. Supply Capacity and Lead Time

Manufacturers must verify the supplier’s capacity to meet current and projected demands. Large-scale API producers often demonstrate better scalability and shorter lead times, crucial for inventory planning and market supply.

3. Cost-Efficiency

While low-cost providers, predominantly in India and China, present competitive pricing, volume discounts and long-term agreements can optimize overall procurement costs without compromising quality.

4. Regulatory Track Record

A supplier's history of regulatory filings and approvals indicates reliable validation of manufacturing quality and process controls, reducing compliance risks.

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Supply Chain Dynamics and Risks

The geopolitical landscape, trade policies, and global pandemic impacts can influence API supply chains. Recent disruptions emphasize the need for diversification of sources and strategic stockpiles. Manufacturers are advised to establish relationships with multiple suppliers across regions to mitigate risks associated with supply shortages or quality issues.

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Emerging Trends and Innovations

Micronization Technology: Advancements in micronization processes enhance API bioavailability, leading to higher therapeutic efficacy and patient compliance. Suppliers investing in state-of-the-art micronization facilities position themselves as preferred partners.

Supply Chain Transparency: Increasing demand for supply chain transparency and quality audits facilitates better risk management. Suppliers providing detailed documentation, batch records, and compliance reports are favored.

Vertical Integration: Some manufacturers are integrating API production with formulation facilities, improving quality control and reducing dependency on external API sources.

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Regulatory and Intellectual Property Considerations

While fenofibrate is off-patent in many regions, manufacturers must navigate patent landscapes in specific jurisdictions. Ensuring that API sources are compliant with local IP regulations and quality standards minimizes legal and regulatory penalties.

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Conclusion

Securing high-quality, reliable, and scalable API sources for micronized fenofibrate remains vital for pharmaceutical companies manufacturing Tricor or its generics. Leading suppliers in China and India offer diverse options, but due diligence concerning quality certifications, regulatory compliance, and supply capacity is paramount. Building strategic supplier relationships and diversifying sourcing channels will enhance resilience and ensure uninterrupted supply of this essential lipid-lowering API.

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Key Takeaways

• Quality certifications, including GMP, USFDA, and EMA approvals, are non-negotiable in API sourcing.
• Asian manufacturers, especially from India and China, dominate the fenofibrate API market due to cost efficiencies and scaled production.
• Supply chain diversification is crucial to mitigate risks from geopolitical or logistical disruptions.
• Technological improvements in micronization enhance API bioavailability, influencing formulation decisions.
• Regulatory compliance and patent considerations must guide sourcing to ensure legality and market access.

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FAQs

1. Are there approved generic sources of fenofibrate API?
Yes. Several Indian and Chinese manufacturers produce FDA-approved, GMP-compliant fenofibrate APIs suitable for generic formulations.

2. What are the latest regulatory standards for fenofibrate API?
Regulatory standards require compliance with pharmacopeial monographs (USP, EP, BP), GMP certification, and, in many cases, USFDA or EMA approval for both manufacturing and export.

3. How does micronization affect fenofibrate API sourcing?
Micronization improves bioavailability. Suppliers offering micronized fenofibrate have specialized processes ensuring particle size uniformity and purity.

4. Can suppliers provide batch-specific documentation?
Most certified suppliers furnish comprehensive documentation, including COA (Certificate of Analysis), batch records, and stability data, essential for regulatory submissions.

5. Is domestic sourcing viable for fenofibrate APIs?
While domestic sourcing exists in some markets, Chinese and Indian manufacturers dominate due to scale and cost advantages, though importing from these regions remains standard.

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References

[1] Market data and analysis from IQVIA.
[2] Regulatory standards documented by pharmacopeias (USP, EP).
[3] Industry reports on API manufacturing market.
[4] Supplier websites and certification disclosures.