Fenofibrate 49562-28-9 — China API Manufacturer | EP USP BP R&D to Production

China Manufacturing Landscape for Fenofibrate

Fenofibrate (CAS 49562-28-9) is a widely prescribed fibric acid derivative used in the management of dyslipidemia, hypercholesterolemia, and hypertriglyceridemia. As one of the highest-volume lipid-lowering APIs globally, Fenofibrate represents a significant manufacturing opportunity where Chinese producers have established dominant market positions through scale, efficiency, and consistent pharmacopeial quality. Our production facility is a leading Chinese manufacturer of Fenofibrate API, supplying pharmaceutical formulators and distributors across more than 50 countries.

With multi-hundred-ton annual production capacity and a proven regulatory track record spanning over a decade of continuous international supply, our facility provides the scale and reliability that large generic pharmaceutical companies require. Our vertically integrated production model controls costs from raw material synthesis through final API finishing, enabling competitive pricing that supports affordable medicine access in markets worldwide.

Manufacturing Process & Facility Overview

Fenofibrate synthesis at our facility follows a well-established multi-step chemical synthesis route. The process involves Friedel-Crafts acylation to construct the benzophenone core, followed by chlorination and esterification with isopropanol to form the final fibrate ester. Each synthetic step is conducted in dedicated reactor trains with automated process control, including real-time monitoring of temperature, agitation, and reagent addition rates to ensure reproducible reaction outcomes.

The production complex includes large-scale glass-lined and stainless steel reactors (2,000L to 10,000L capacity), continuous centrifugation systems, vacuum drying equipment, and precision jet milling for particle size control. For micronized Fenofibrate grades, we operate dedicated air-jet milling suites with validated particle size distribution controls achieving D90 values below 10 μm. The facility operates under pharmaceutical quality controls with fully validated utilities including purified water, clean steam, and compressed air systems.

Quality Standards & Multi-Pharmacopeial Compliance

Our Fenofibrate API is produced and released in compliance with European Pharmacopoeia (EP), United States Pharmacopeia (USP), and British Pharmacopoeia (BP) specifications. The analytical control strategy includes assay by HPLC (purity ≥99.0%), related substances profiling with specified and unspecified impurity limits, identification by IR and HPLC, melting point determination, loss on drying, residue on ignition, heavy metals testing, and particle size distribution analysis for micronized grades.

Both standard crystalline and micronized grades are available, with the micronized form produced under validated milling processes with in-line laser diffraction particle size monitoring. Our QC laboratory operates with a complete instrument suite including Waters UPLC, Malvern Mastersizer for particle sizing, TA Instruments DSC for polymorphic form confirmation, and Bruker X-ray diffractometer. All methods are validated per ICH Q2(R1) guidelines.

Regulatory Documentation & Export Support

Our Fenofibrate API is supported by an extensive regulatory documentation package including US FDA Drug Master File (DMF), Certificate of Suitability (CEP) issued by EDQM for European market access, and WHO Prequalification documentation. Additional standard deliverables include batch Certificates of Analysis, MSDS/SDS, stability study reports per ICH Q1A, and process validation summaries. We have successfully supported customer ANDA filings with the US FDA and generic drug applications across Europe, Asia, and Latin America.

Our experienced regulatory affairs team provides responsive support for customer regulatory queries, post-approval change notifications, and annual product quality review documentation. We maintain active pharmacovigilance monitoring and regulatory intelligence tracking across key markets.

Packaging & Global Logistics

Fenofibrate API is packaged in double-layer polyethylene bags within fiber drums, with standard net weights of 25 kg per drum. For micronized grades, packaging is conducted under controlled humidity conditions with nitrogen overlay to prevent moisture uptake and agglomeration. Bulk packaging in 50 kg drums and custom configurations are available for high-volume orders. All packaging is labeled with complete regulatory and traceability information.

We support all major Incoterms including FOB, CIF, and DDP, with shipments typically routed through Shanghai or Ningbo ports. Standard ocean freight transit times range from 18-25 days to European destinations and 25-35 days to Latin American ports. For time-sensitive requirements, air freight delivery is available within 5-7 business days to most global destinations.

Competitive Pricing & Supply Reliability

Our large-scale production capacity and integrated manufacturing model enable us to offer Fenofibrate at the most competitive competitive pricing available from any quality-certified source globally. We provide transparent pricing with volume-based discounts, annual contract options with price guarantees, and flexible payment terms for established customers. Our pricing competitiveness has made us a preferred supplier for cost-sensitive generic drug manufacturers across emerging markets.

Supply reliability is anchored by substantial production capacity, diversified raw material sourcing, and strategic finished goods inventory management. We maintain buffer stock equivalent to 60-90 days of average demand, ensuring rapid response to both planned orders and urgent requirements. Historical on-time delivery performance exceeds 98% across all customer accounts.

Fenofibrate Technical Specifications