Bulk Pharmaceutical API Sources for clofibrate

Bulk Pharmaceutical API Sources for clofibrate

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		C6643_SIGMA
TCI (Tokyo Chemical Industry)		C0941
Molport		MolPort-000-145-477
Amadis Chemical		A834483
TimTec		SBB099633

Bulk Active Pharmaceutical Ingredient (API) Sources for Clofibrate: An Industry Overview

Last updated: November 7, 2025

Introduction

Clofibrate, a lipid-lowering agent historically used to reduce serum triglycerides and cholesterol, remains relevant within pharmaceutical formulations despite its waning clinical prominence. Its synthesis and procurement depend heavily on reliable API suppliers, which are integral to pharmaceutical manufacturing, regulatory compliance, and global supply chain stability. This analysis examines key sources for bulk cloifibrate API, exploring manufacturing geographies, supplier profiles, quality standards, and market dynamics shaping the supply landscape.

Overview of Clofibrate API Production

Clofibrate’s chemical synthesis involves the esters of phenoxyisobutyric acid, requiring precise manufacturing processes to ensure purity, potency, and stability. Its production is concentrated within regions with established pharmaceutical industries, including India, China, and select European countries. The API’s manufacturing landscape has evolved, influenced by regulatory demands, cost considerations, and technology transfer capabilities.

Major Geographic Regions Supplying Clofibrate API

1. India

India remains a dominant supplier of generic APIs, including cloifibrate, owing to its robust pharmaceutical sector characterized by cost-efficient manufacturing, a skilled workforce, and extensive export networks. Prominent Indian API manufacturers such as Divi's Laboratories, Ankaa Life Science, and Biostadt India have established formulations and production lines conforming to international standards such as WHO-GMP and ICH.

• Manufacturing Capabilities: Indian suppliers offer high-volume API production, with the capability to meet both domestic and export demand.
• Quality & Certification: Many Indian manufacturers possess USFDA, EU-GMP, and MOU certifications, ensuring compliance with stringent regulatory standards.
• Supply Stability: Indian firms maintain stable supply chains, supported by government incentives promoting API manufacturing.

2. China

China has historically supplied a broad spectrum of APIs, including cloifibrate. Its manufacturing infrastructure benefits from inexpensive raw materials, large-scale chemical production facilities, and ongoing technology upgrades.

• Manufacturers: Companies like North China Pharmaceutical Group Corporation (NCPC), Qilu Pharmaceutical, and Hainan Shuangpro Pharmaceutical Co. produce bulk cloifibrate API.
• Regulatory Environment: While Chinese API manufacturers often excel in cost competitiveness, regulatory scrutiny varies, with international clients increasingly seeking suppliers with recognized quality certifications.
• Market Dynamics: China's API industry faces challenges related to quality consistency and intellectual property, but investments in Good Manufacturing Practices (GMP) and certification processes are ongoing.

3. Europe

Europe hosts a smaller, highly regulated API manufacturing sector, with companies emphasizing quality, regulatory compliance, and advanced manufacturing techniques.

• Key Players: Evonik Industries, BASF, and specialized contract manufacturing organizations (CMOs) produce APIs meeting EMA and FDA standards.
• Market Position: European APIs are often preferred for high-end formulations, owing to strict compliance and quality assurance.
• Supply Considerations: Though less cost-competitive, European suppliers offer reliable quality assurance and transparency, critical for regulated markets.

4. Other Regions

• United States: Limited domestic production of cloifibrate API due to regulatory and market considerations; US-based companies primarily focus on contract manufacturing.
• Southeast Asia: Emerging players in Vietnam and Thailand are beginning to offer APIs, driven by regional manufacturing growth and increasing regulatory standards.

Key Factors Influencing API Supply

Regulatory Compliance

The pharmaceutical industry demands high-quality APIs conforming to international standards. Suppliers with GMP certification, especially from agencies like USFDA, EMA, or WHO, are preferred. Such compliance ensures safety, efficacy, and facilitates market access.

Cost and Pricing Dynamics

Cost advantages primarily influence sourcing decisions. Indian and Chinese manufacturers typically offer more competitive pricing due to lower labor and raw material costs, making them attractive for volume procurement.

Quality Assurance and Certification

Quality certifications underpin procurement stability. Suppliers with comprehensive quality control protocols, validated manufacturing processes, and transparent testing demonstrate reliability amid regulatory inspections.

Supply Chain Reliability

Long-term partnerships depend on consistent supply, logistical efficiency, and inventory management. Suppliers demonstrating technological capability and logistical resilience are favored, especially for large-scale production.

Market Trends and Supply Chain Challenges

• Regulatory Stringency: Increasing global regulatory standards necessitate rigorous supplier qualification processes.
• Supply Chain Disruptions: COVID-19 exposed vulnerabilities in global API supply chains, emphasizing the need for diversified sourcing.
• Environmental and Sustainability Regulations: Manufacturers are adapting to environmental standards, potentially impacting production costs and processes.
• Technological Advances: Process innovations and continuous manufacturing techniques improve API purity, cost efficiency, and environmental footprint.

Future Outlook

The supply landscape for cloifibrate API is expected to remain stable, driven by longstanding manufacturing expertise in India and China. However, market shifts towards stricter quality standards and environmental regulations could reshape supplier dominance, favoring highly compliant and technologically advanced firms. Moreover, the dwindling clinical use of cloifibrate may impact strategic sourcing, favoring suppliers with diversified portfolios.

Key Considerations for Stakeholders

• Due Diligence: Evaluate suppliers’ regulatory certifications, quality track records, and capacity to meet demand.
• Qualification Processes: Implement supplier qualification protocols aligned with international standards.
• Supply Chain Diversification: Minimize risks through multi-sourced procurement strategies.
• Legal and Contractual Clarity: Ensure clear contractual obligations regarding quality, delivery timelines, and regulatory compliance.

Conclusion

Clofibrate API sourcing relies predominantly on Indian and Chinese manufacturers, with European suppliers catering to high-end, regulated markets. The industry’s evolution balances cost, quality, and supply stability, with ongoing regulatory developments exerting influence. Strategic partnerships with certified, reliable suppliers remain critical to ensuring supply chain resilience, compliance, and cost-effectiveness.

---

Key Takeaways

• India and China dominate the global cloifibrate API supply, driven by cost advantages and manufacturing scale.
• Suppliers with international GMP certifications and proven quality controls are preferred for regulated markets.
• Supply chain resilience depends on diversification, quality assurance, and adherence to evolving regulatory standards.
• Future procurement strategies should consider technological innovations, environmental regulations, and supplier reliability amidst changing industry dynamics.
• Stakeholders must perform rigorous supplier qualification and ongoing quality audits to mitigate risks.

---

Frequently Asked Questions (FAQs)

1. What are the primary challenges in sourcing cloifibrate API globally?
Supply chain disruptions, regulatory compliance variability, and differing quality standards pose significant challenges. Ensuring supplier certification and continuous quality audits help mitigate these risks.

2. How do Indian and Chinese cloifibrate API suppliers compare?
Indian suppliers often offer higher regulatory compliance and competitive pricing, while Chinese manufacturers provide cost-effective large-volume production but may vary in regulatory adherence. Both are capable if thoroughly vetted.

3. Is cloifibrate API production declining, and how does that affect supply?
Yes, due to reduced clinical use, production volumes have declined. While existing suppliers remain capable, procurement may face supply constraints and higher prices owing to limited manufacturing capacity.

4. What quality certifications are most critical for cloifibrate API suppliers?
GMP certification from agencies like USFDA, EMA, and WHO is essential. Additional certifications, such as ISO certifications, enhance supplier credibility.

5. How can companies ensure supply chain resilience for cloifibrate API?
Diversifying suppliers across regions, establishing long-term partnerships, maintaining inventory buffers, and conducting rigorous supplier qualification processes bolster resilience.

---

References

1. World Health Organization. "WHO Good Manufacturing Practices." [Online]. Available: https://www.who.int/
2. U.S. Food and Drug Administration. "Guidance for Industry: Quality Systems Approaches for Pharmaceutical Manufacturers." 2020.
3. India Brand Equity Foundation. "Pharmaceuticals & Healthcare Industry." 2021.
4. China Pharmaceutical Industry Association. "Pharmaceutical Industry Report," 2022.
5. European Medicines Agency. "Guidelines on Good Manufacturing Practice." 2021.