Lipid-regulating agent API
Fenofibrate API
Manufactured in-house at our Saykha GIDC plant in IP, BP, USP and EP grades — micronised and defined particle-size options available, supplied with batch CoA as standard and DMF support for regulated filings.
Overview
Fenofibrate is a fibrate lipid-regulating agent used in formulations for hypercholesterolaemia and mixed dyslipidaemia. Because it is poorly water-soluble, particle size directly governs dissolution and bioavailability, so formulators need a source that can hold both the impurity profile and the particle-size specification steady across every campaign.
Apex Pharma API has manufactured Fenofibrate since 2015 on a single established route and can supply micronised and defined particle-size grades from the same plant. You buy directly from the site that makes and mills it, with the QC team that released the batch available to answer your questions.
Specifications
| Product name | Fenofibrate (bulk active pharmaceutical ingredient) |
|---|---|
| CAS number | 49562-28-9 |
| Molecular formula | C20H21ClO4 |
| Molecular weight | 360.83 |
| Grades available | IP · BP · USP · EP |
| Appearance | White to almost white crystalline powder |
| Assay | Per applicable pharmacopoeial monograph (grade-specific) |
| Packaging | 1 kg / 5 kg / 25 kg — HDPE drum with double LDPE liner; other configurations on request |
| Storage | Store in a tightly closed container, protected from light and moisture, at controlled room temperature |
| Supply capacity | Trial quantities to repeat commercial volumes — confirmed at quotation |
Full specification sheet and method of analysis issued with the quotation. Packaging and storage confirmed per destination market.
Applications
Oral solid dosage forms for hypercholesterolaemia and mixed dyslipidaemia.
Micronised grade supplied where particle size drives dissolution and bioavailability.
Defined particle-size material for capsule and modified-bioavailability formats.
Fixed-dose combinations where a consistent impurity and particle-size profile is required.
Regulatory & documentation
Everything your QA and regulatory teams need to open a file on us, issued at quotation stage rather than after the order.
Fenofibrate API — buyer questions
What is the minimum order quantity for Fenofibrate API?
We supply from trial quantities upward. The commercial MOQ depends on the grade, particle-size specification and pack size you need and is confirmed at quotation.
Can I request a micronised sample with a CoA?
Yes. Samples — including micronised grade — are issued with the batch CoA so your QC team can check particle size and assay against your specification before ordering.
What lead time applies?
Stocked grades despatch within days of order confirmation. Micronised campaigns and larger volumes are scheduled with a firm date given before you commit.
Is a DMF available for regulated markets?
DMF support and open-part documentation are available on request. Tell us the market and particle-size requirement and we will confirm what we can provide.
Related products
Read: Fenofibrate uses and applications →Get a Fenofibrate API quote
Grade, quantity, destination — we will come back with price, lead time and documentation.