Fenofibrate API Manufacturer & Supplier in India
WHO-GMP certified bulk Fenofibrate supplier - micronized & non-micronized grades, USP/EP/BP/IP compliant, PMDA Japan approved
Looking for a reliable supplier of Fenofibrate?
DK Pharmachem is a WHO-GMP certified Fenofibrate API manufacturer based in India, supplying bulk Fenofibrate (CAS 49562-28-9) in micronized and non-micronized grades to pharmaceutical companies across regulated and emerging markets worldwide. With over four decades of API manufacturing expertise at our dedicated facility in Badlapur, Maharashtra, we produce Fenofibrate to USP, EP, BP, and IP pharmacopoeial standards – at ≥99% purity – backed by full regulatory documentation including Certificate of Analysis, MSDS, and Drug Master File (DMF/EDMF) support.
As one of the most widely prescribed lipid-lowering APIs globally, Fenofibrate is a high-volume, commercially critical molecule for cardiovascular and metabolic therapy formulation manufacturers. DK Pharmachem’s established production capacity, PMDA Japan approval, and multi-pharmacopoeia compliance make us a trusted single-source Fenofibrate supplier for both regulated and emerging market pharmaceutical companies.
Fenofibrate API
Technical Specifications
| Attribute | Details |
|---|---|
| Pharmacopoeia Standard | USP / EP |
| CAS Number | 49562-28-9 |
| Molecular Formula | C₂₀H₂₁ClO₄ |
| Molecular Weight | 360.83 g/mol |
| Therapeutic Application | Lipid-lowering agent (antihyperlipidemic) |
| DMF / EDMF Status | Available |
| Manufacturing Standard | WHO-GMP Certified |
| Appearance | White crystalline powder |
| Purity | ≥ 99% (HPLC) |
| Melting Point | 79-82°C |
| Available Forms | Micronized grade, Non-micronized grade |
| Particle Size (micronized) | D90 ≤10 μm |
| Shelf Life | 36 months from date of manufacture under recommended storage conditions |
| Available Pack Sizes | 1 kg, 5 kg, 25 kg, custom bulk quantities on request |
Fenofibrate API Manufacturing Process, WHO-GMP Compliance & Regulatory Filings
Fenofibrate API at DK Pharmachem is produced through a controlled multi-step organic synthesis and crystallisation process at our dedicated manufacturing facility in Badlapur, Maharashtra. Each stage — reaction, purification, drying, and micronisation (for micronized grade) — is validated and monitored under stringent cGMP conditions to ensure batch-to-batch consistency in purity, particle size distribution, and impurity profile. Our WHO-GMP certified facility operates in-house quality control laboratories equipped with HPLC, GC, UV spectrophotometry, and laser diffraction particle size analysis for comprehensive batch release testing.
DK Pharmachem holds PMDA Japan approval for Fenofibrate - one of the most stringent regulatory credentials in the global pharmaceutical industry - alongside Drug Master File (DMF/EDMF) documentation to support your market authorisation requirements across the US, EU, Japan, and other regulated markets. Full regulatory packages including Certificate of Analysis, MSDS, impurity profiles, and stability data are available on request.
WHO-GMP compliant manufacturing facilities
Validated processes for Fenofibrate Generic API
High purity Fenofibrate (≥99%) controlled impurities
Consistent particle size - Micronized & Non-micronized
In-process and final quality testing
Complete batch traceability and documentation
Our infrastructure supports dependable supply for both domestic and international markets.
Bulk Fenofibrate Supply, Packaging Options & Export Logistics
DK Pharmachem supplies Fenofibrate API in both micronized and non-micronized forms, packaged to maintain chemical stability and protect from light and moisture throughout transit. Standard packaging is in double-polyethylene lined HDPE drums or fibre drums, available in 1 kg, 5 kg, and 25 kg pack sizes. Custom bulk packaging configurations for high-volume procurement are available on request - contact our team with your specific quantity, grade, and timeline requirements.
We export bulk Fenofibrate API to pharmaceutical manufacturers across Asia-Pacific, the Middle East, Africa, Latin America, Europe, the United States, and Japan. Standard lead times from order confirmation are 10-15 working days for stocked material. All export shipments are accompanied by a complete documentation pack - Certificate of Analysis, MSDS, and any DMF/EDMF letters of access or market-specific regulatory documents required for your destination.
Packaging Options
- Pharmaceutical-grade sealed containers
- Customized bulk packaging available
- 1 kg, 5 kg, and 25 kg pack sizes
- Custom bulk + HDPE double-PE lined drums detail
Handling & Storage
- Store in a cool, dry environment
- Protect from moisture and excessive heat
- Keep containers tightly closed
- Handle according to standard pharmaceutical safety guidelines
Proper storage helps preserve shelf life and performance.
Bulk Fenofibrate Supply, Packaging Options & Export Logistics
Partner with a WHO-GMP certified supplier for consistent quality, regulatory compliance, and reliable supply of Fenofibrate for your critical applications.
Why Pharmaceutical Companies Source Bulk Fenofibrate API from India
India is one of the world's largest producers of cardiovascular and metabolic therapy APIs, supplying Fenofibrate and other lipid-lowering molecules to generic drug manufacturers across the US, Europe, Japan, and over 150 other countries. For procurement teams sourcing Fenofibrate API at commercial scale, Indian manufacturers offer a combination of production capacity, regulatory compliance depth, and formulation-grade quality that is difficult to match in other sourcing regions. DK Pharmachem, with over four decades of API manufacturing expertise and PMDA Japan approval, represents the highest standard of this capability.
Trusted fenofibrate manufacturer and fenofibrate supplier
High-purity API (≥99%) with consistent batch quality
WHO-GMP certified manufacturing
Strong regulatory and documentation support
Reliable bulk supply and long-term contracts
Competitive fenofibrate price based on volume and market
D.K. Pharmachem is a dependable partner for pharmaceutical companies seeking consistent, high-quality Fenofibrate supply.
Frequently Asked Questions
Find answers to common questions about Fenofibrate products and services