Fenofibrate

In today’s healthcare landscape, managing lipid disorders has become a top priority due to the increasing prevalence of cardiovascular diseases, metabolic syndrome, and type 2 diabetes. One of the most trusted lipid-lowering agents is Fenofibrate, a fibric acid derivative known for its efficacy in reducing triglyceride levels, increasing HDL cholesterol, and improving overall lipid profiles in patients at risk of atherosclerosis and heart disease.

At BluepillExpress, we offer third-party manufacturing services for Fenofibrate in compliance with global standards. Our WHO-GMP-certified facilities, end-to-end production capabilities, and global export infrastructure make us a preferred partner for pharmaceutical companies, government tenders, and private healthcare brands seeking high-quality Fenofibrate formulations.

About BluepillExpress

BluepillExpress is a globally recognized name in pharmaceutical contract manufacturing and exports, serving over 25 countries across Asia, Africa, the Middle East, CIS regions, and Latin America. We specialize in providing turnkey manufacturing solutions that include:

• API sourcing and formulation development
• WHO-GMP-compliant batch manufacturing
• Private labeling and customized packaging
• Regulatory documentation support
• International freight and export clearance

With deep expertise in manufacturing cardiovascular and metabolic drugs, we ensure that our clients receive reliable, cost-effective, and therapeutically robust products tailored to meet their regional and regulatory requirements.

Product Overview: Fenofibrate

Fenofibrate is a fibric acid derivative used to reduce serum triglycerides and LDL cholesterol levels, while increasing HDL (good) cholesterol. It plays a vital role in the management of mixed dyslipidemia, especially in patients with diabetes mellitus, obesity, or a high risk of cardiovascular events.

Fenofibrate is typically indicated for:

• Primary hypercholesterolemia (Type IIa)
• Mixed dyslipidemia (Type IIb)
• Severe hypertriglyceridemia (Type IV and V)
• Adjunct to statin therapy for patients not adequately controlled
• Hyperlipidemia associated with type 2 diabetes

It is also used off-label in the prevention of diabetic retinopathy and the treatment of fatty liver disease (NAFLD/NASH), making it a valuable product in cardiometabolic portfolios.

Mechanism of Action

Fenofibrate is a peroxisome proliferator-activated receptor-alpha (PPAR-α) agonist. Activation of PPAR-α leads to:

• Increased oxidation of fatty acids
• Enhanced lipoprotein lipase activity
• Reduction in apolipoprotein C-III
• Increased synthesis of apolipoproteins A-I and A-II
• Decreased hepatic production of very low-density lipoproteins (VLDL)

These mechanisms contribute to lowering triglycerides, reducing LDL, and raising HDL, thereby decreasing the risk of cardiovascular complications.

Available Dosage Forms

BluepillExpress manufactures Fenofibrate in a range of oral dosage forms and strengths, suitable for global regulatory and therapeutic requirements:

1. Fenofibrate Tablets / Capsules (Micronized / Standard)

• 67 mg
• 145 mg
• 160 mg
• 200 mg (on request)
• Micronized versions for enhanced bioavailability
• Film-coated or gelatin capsules as per market demand

2. Fenofibrate Extended-Release Capsules (custom development)

• Once-daily dosing options
• Suitable for chronic use with improved compliance

All products comply with IP, BP, USP, and Ph. Eur. standards, and are designed for optimal dissolution, stability, and absorption.

Packaging Solutions

We provide customized packaging solutions for different dosage forms to suit diverse market preferences and regulatory environments:

For Tablets / Capsules:

• Alu-Alu or PVC/Alu blister packs
• Strip packaging (10×10, 1×10, or 1×15 formats)
• Bulk HDPE containers for institutional supply
• Mono-cartons with printed inserts and patient leaflets

Optional Features:

• Child-resistant closures
• Tamper-evident labeling
• Multilingual text for international markets
• Country-specific barcoding and serialization

All packaging materials are sourced from certified suppliers and are compliant with WHO and FDA guidelines on labeling, stability, and patient safety.

Manufacturing Infrastructure

All Fenofibrate formulations are produced at our WHO-GMP-certified facilities, equipped with:

• Granulation and fluid-bed processing systems
• Tablet compression, coating, and capsule filling lines
• HVAC-controlled cleanroom environments
• In-house water purification and sterilization systems
• Dedicated microbiology and analytical testing labs
• Controlled-access storage and warehousing systems

Our batch manufacturing follows strict Standard Operating Procedures (SOPs), overseen by trained personnel and supported by a robust quality assurance framework.

Quality Control and Assurance

At BluepillExpress, we implement a multi-stage quality control system to ensure that each Fenofibrate product meets the highest standards of efficacy and safety. Our QA/QC practices include:

• Raw material and API identification and assay
• In-process controls during granulation, compression, and packaging
• Finished product testing:
  • Assay
  • Dissolution and disintegration
  • Uniformity of dosage units
  • Stability (accelerated and real-time)
  • Microbial load and sterility (where applicable)

We manufacture Fenofibrate formulations in full compliance with:

• IP/BP/USP/Ph. Eur. monographs
• ICH Q6A and Q1A stability guidelines
• WHO and ISO 9001:2015 quality systems

Regulatory Support and Documentation

We provide complete regulatory documentation support to facilitate product registration and market entry in both regulated and semi-regulated markets. Our documentation package includes:

• Certificate of Pharmaceutical Product (CoPP)
• Certificate of Analysis (CoA)
• Manufacturing license and WHO-GMP certificate
• Free Sale Certificate
• Common Technical Document (CTD) Dossiers
• Method validation and analytical data
• Stability studies and packaging information
• Material Safety Data Sheet (MSDS)

Our regulatory affairs team ensures quick turnaround times and full support during product registration, dossier evaluation, and approval processes.

Export Market and Logistics Support

BluepillExpress has a proven track record of exporting pharmaceuticals to over 25 countries across five continents. Our logistics and supply chain teams ensure:

• Timely production and dispatch
• Export documentation and regulatory support
• Labeling and barcoding as per destination requirements
• Door-to-door logistics solutions (air, sea, or multimodal)
• Cold chain management (for temperature-sensitive products)

We serve clients in:

• Africa – Nigeria, Kenya, Ghana, Ethiopia, South Africa
• Asia – Vietnam, Sri Lanka, Myanmar, Philippines, Bangladesh
• Middle East – UAE, Saudi Arabia, Iraq, Oman, Jordan
• CIS – Kazakhstan, Uzbekistan, Georgia
• LATAM – Peru, Bolivia, Dominican Republic

Target Clients and Market Applications

BluepillExpress supports a wide range of healthcare stakeholders, including:

• Generic pharmaceutical companies
• Branded marketers and private-label suppliers
• Government tenders and institutional procurement
• Hospitals and cardiovascular clinics
• E-commerce and telemedicine platforms
• Global distributors and wholesalers

We provide scalable production volumes, starting from low minimum order quantities (MOQs) to large-scale institutional supplies, making our services ideal for startups and established enterprises alike.

Why Partner with BluepillExpress?

1. WHO-GMP Certified Production Facilities
   Delivering high-quality formulations with international regulatory acceptance.
2. Flexible Manufacturing and Customization
   Offering various dosage strengths, forms, and packaging configurations.
3. Comprehensive Regulatory and Dossier Support
   Supporting quick and smooth market registration across global territories.
4. End-to-End Export and Logistics Services
   Ensuring timely delivery with full compliance and tracking.
5. Experienced in Cardiovascular and Metabolic Formulations
   Proven manufacturing history of lipid-lowering and chronic care medications.
6. Affordable Pricing and Global Reach
   Ensuring quality healthcare at accessible costs in both developed and developing markets.

Conclusion

Fenofibrate is a globally trusted medication for managing complex lipid profiles and reducing cardiovascular risk, especially in patients with diabetes and metabolic disorders. Its strong efficacy, favorable tolerability, and broad clinical acceptance make it an essential product in the cardiometabolic drug portfolio.

At BluepillExpress, we bring together scientific expertise, state-of-the-art infrastructure, and regulatory acumen to offer reliable third-party manufacturing solutions for Fenofibrate. Whether you are expanding your chronic care range or building a cardiovascular brand, we help you deliver products that meet the highest standards of safety, quality, and therapeutic effectiveness.