Bulk Pharmaceutical API Sources for TRIGLIDE

Bulk Pharmaceutical API Sources for TRIGLIDE

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
TimTec		ST085313
Amadis Chemical		A827746
TCI (Tokyo Chemical Industry)		F0674

Bulk Active Pharmaceutical Ingredient (API) Sources for Triglide

Last updated: July 29, 2025

Introduction

Triglide, marketed as a prescription medication combining fenofibrate with a lipophilic delivery system, is primarily utilized for managing hyperlipidemia and hypertriglyceridemia. Its efficacy depends significantly on the quality and reliability of its active pharmaceutical ingredient (API), fenofibrate. As a vital component, the sourcing of fenofibrate APIs influences regulatory compliance, manufacturing efficiency, and product consistency. This report provides a comprehensive overview of bulk fenofibrate API sources relevant to Triglide, highlighting key manufacturers, geographic distribution, supply considerations, and quality standards.

Understanding Fenofibrate as the API for Triglide

Fenofibrate, a fibric acid derivative, acts as a peroxisome proliferator-activated receptor alpha (PPARα) agonist, effectively reducing triglycerides and modulating lipid profiles. The quality of fenofibrate APIs directly impacts Triglide's therapeutic performance, underscoring the importance of sourcing from reputable suppliers adhering to strict quality standards such as Good Manufacturing Practices (GMP) and international pharmacopoeias.

Major Global API Suppliers for Fenofibrate

1. European and American Contract Manufacturing and API Suppliers

a. Lonza Group (Switzerland)
Lonza is a leading global supplier of pharmaceutical ingredients, including fenofibrate. They maintain rigorous quality controls, GMP compliance, and supply chain transparency. Their facilities are certified under multiple regulatory standards, including EMA and FDA.

b. BASF (Germany)
BASF manufactures fenofibrate APIs for various pharmaceutical partners under GMP conditions. Their extensive R&D capacity and quality assurance protocols make them a preferred supplier in Europe and North America.

c. Cambrex (USA)
Cambrex specializes in custom synthesis of small molecule APIs, including fenofibrate. Their facilities are FDA-registered with ISO certifications, ensuring high-quality production for global markets.

2. Asian API Manufacturers

a. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
A prominent Chinese pharmaceutical company with a significant API manufacturing footprint. Zhejiang Hisun adheres to GMP standards and supplies fenofibrate APIs globally, often at competitive prices.

b. Jiangsu Hengrui Medicine Co., Ltd. (China)
Hengrui offers high-quality APIs, including fenofibrate, with certifications aligning to international standards. Their extensive R&D infrastructure enhances API purity and consistency.

c. Zhejiang Jianeng Pharmaceutical Co., Ltd. (China)
This manufacturer supplies fenofibrate APIs to global markets, emphasizing regulatory compliance and affordability.

3. Indian API Manufacturers

a. Dr. Reddy’s Laboratories
Dr. Reddy’s produces fenofibrate APIs that meet international quality standards and supply both generic and branded formulations.

b. Torrent Pharmaceuticals
Torrent offers GMP-certified fenofibrate APIs, with a focus on quality, cost-efficiency, and reliable supply.

c. Biocon Limited
Biocon's API manufacturing facilities are compliant with global standards, providing fenofibrate APIs for export.

4. Other Noteworthy Suppliers

• Sandoz (Novartis Group): Known for high-quality APIs, Sandoz supplies fenofibrate for global use, emphasizing regulatory compliance.
• Hovid Berhad (Malaysia): A regional supplier with GMP-certified facilities offering fenofibrate APIs.

Factors Influencing API Source Selection

a. Regulatory Compliance and Certifications

Suppliers must adhere to GMP, ISO, and other regulatory standards relevant to the target markets, such as FDA approval in the United States and EMA approval in Europe.

b. Quality and Purity Standards

API purity typically exceeds 99%, with strict control of residual solvents, impurities, and polymorphic forms. Certificates of Analysis (CoA) and batch consistency are vital.

c. Supply Chain Reliability

Consistent delivery, scalable production capacity, and risk mitigation strategies safeguard against shortages or delays.

d. Cost and Lead Time

Pricing competitiveness must be balanced against quality standards, with lead times aligning with manufacturing schedules.

e. Geographic Proximity and Trade Policies

Customs, tariffs, and regional regulations influence sourcing decisions, often favoring local or regional suppliers for reduced logistical complexity.

Emerging Trends in API Sourcing for Fenofibrate

• API Harmonization and Regulatory Evolution: As regulators streamline approval procedures, manufacturers seek suppliers with harmonized quality standards that facilitate global distribution.
• Supply Chain Diversification: Ensuring multiple sourcing options minimizes geopolitical risks and prevents disruptions.
• Vertical Integration: Some pharmaceutical companies are investing in in-house API manufacturing lines for enhanced control and cost management.

Supply Chain Challenges and Risk Management

Sourcing fenofibrate API entails navigating complex logistical, geopolitical, and quality assurance considerations. The COVID-19 pandemic underscored vulnerabilities in global supply chains, prompting increased emphasis on diversified sourcing and localized manufacturing options.

Pharmaceutical companies must establish robust qualification processes, including audits and analytical testing, to ensure supplier compliance. Maintaining strong supplier relationships and contingency plans are vital for uninterrupted manufacturing of Triglide.

Conclusion

The successful commercial production of Triglide hinges on sourcing high-quality fenofibrate APIs from reputable suppliers. The market offers a diverse pool of global manufacturers, primarily in Europe, North America, China, and India. Strategic selection based on regulatory compliance, quality assurance, cost, and supply reliability mitigates risks and supports consistent product efficacy.

Key Takeaways

• The primary API for Triglide, fenofibrate, is produced by numerous suppliers worldwide, with the leading regions being Europe, North America, and Asia.
• Regulatory compliance (GMP, ISO) and consistent quality are non-negotiable criteria for API supplier selection.
• Diversification of API sources reduces supply chain risks, especially amid geopolitical and logistical challenges.
• Emerging trends favor integrated manufacturing and regional supply chains to ensure quality and timely delivery.
• Robust qualification and qualification processes are critical to maintain standards and support regulatory approvals.

FAQs

1. Why is the choice of API supplier critical for Triglide production?
The API directly influences the drug’s safety, efficacy, and regulatory approval. High-quality sources ensure bioavailability, minimize impurities, and maintain batch-to-batch consistency essential for patient safety.

2. What are the key quality standards for fenofibrate APIs?
APIs should meet Pharmacopeial standards (USP, EP, JP), with purity >99%, low residual solvents, controlled polymorphic forms, and documented stability profiles. GMP compliance is essential.

3. Are Chinese API manufacturers a reliable source for fenofibrate?
Yes. Many Chinese manufacturers, such as Zhejiang Hisun and Jiangsu Hengrui, comply with global regulatory standards and supply high-quality APIs, but rigorous qualification and auditing are recommended.

4. How do supply chain disruptions impact fenofibrate sourcing?
Disruptions can lead to shortages, production delays, and increased costs. Diversification, inventory buffers, and establishing relationships with multiple suppliers mitigate these risks.

5. Is in-house API manufacturing advisable for Triglide?
In-house production offers more control and supply security but requires significant capital investment, regulatory approval, and technical expertise. Many companies prefer reliable external suppliers for flexibility and cost efficiency.

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Sources

[1] U.S. Pharmacopeia. (2022). Fenofibrate Monograph.
[2] European Pharmacopoeia. (2022). Fenofibrate Monograph.
[3] Lonza. (2023). API Portfolio.
[4] BASF. (2023). Pharmaceutical Ingredients.
[5] Zhejiang Hisun Pharmaceutical Co., Ltd. Annual Report.