Lipid-regulating agent API
Fenofibrate API Manufacturer & Supplier in India
Apex Pharma API is a Fenofibrate API manufacturer and supplier based in India, producing bulk active pharmaceutical ingredient for pharmaceutical formulation companies and distributors. Fenofibrate remains one of the most widely prescribed lipid-regulating molecules, and we supply it in-house from our Saykha GIDC plant to the documentation and quality standards B2B buyers rely on when qualifying a new source.
What is Fenofibrate API?
Fenofibrate (CAS No. 49562-28-9) is a fibrate-class, fibric acid derivative that functions as an agonist of peroxisome proliferator-activated receptor alpha (PPARα). Activation of PPARα regulates the expression of genes involved in lipid and lipoprotein metabolism, reducing plasma triglyceride levels and raising HDL cholesterol. Fenofibrate is used in the formulation of antilipemic medicines for hypercholesterolaemia, hypertriglyceridaemia and mixed dyslipidaemia, either alone or alongside other lipid-lowering classes such as statins.
As a third-generation fibrate available generically worldwide, Fenofibrate benefits from an extensive, well-characterised pharmacological and manufacturing literature base — a genuine advantage for formulation companies evaluating process and analytical reference standards.
Fenofibrate API manufacturing at Apex Pharma API
We have manufactured Fenofibrate in-house since 2015 at our Saykha GIDC plant, so the impurity profile stays consistent between campaigns. Because Fenofibrate is poorly water-soluble and particle size directly governs dissolution and bioavailability, we can supply micronised and defined particle-size grades on request, matched to your formulation specification. Our complete product range and general sourcing process are covered on our API manufacturing page.
Applications and uses
Fenofibrate API is formulated into medicines used to manage elevated cholesterol and triglyceride levels, typically as part of a treatment approach that also includes dietary and lifestyle intervention. By activating PPARα, it reduces circulating triglycerides and raises HDL cholesterol, and is used alone or in combination with statin therapy depending on a patient’s lipid profile. This is general pharmacological context for buyer understanding, not a claim about the specific finished-dose products manufactured by any Apex Pharma API customer.
Industries and customers we serve
Fenofibrate API from Apex Pharma API is supplied to pharmaceutical formulation manufacturers producing cardiovascular and metabolic-health tablets and capsules, to distributors supplying API onward within their own network, and to R&D and generic-development teams needing API for formulation trials ahead of scale-up. Our full buyer-segment breakdown is on the API manufacturing companies in India page.
Why choose Apex Pharma API for Fenofibrate API
- Micronised and defined particle-size options on request — so you can match the grade to your dissolution and bioavailability requirement rather than qualifying a second source.
- GMP- and GLP-certified manufacturing (Gujarat FDCA), with an ISO 9001:2015 quality management system and MSME ZED Bronze certification.
- In-house manufacturing since 2015, so the impurity profile is consistent campaign to campaign.
- Manufacturer pricing, quoted directly — you are buying from the plant that makes it, with a batch CoA as standard and DMF documentation available on request.
Product & technical information
| Product name | Fenofibrate (bulk active pharmaceutical ingredient) |
|---|---|
| CAS number | 49562-28-9 |
| Drug class | Fibrate / lipid-regulating agent |
| 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.
Quality & compliance
Manufactured under GMP and GLP certificates from the Gujarat FDCA, with an ISO 9001:2015 quality management system and MSME ZED Bronze certification. A batch-wise Certificate of Analysis is issued as standard, and everything your QA and regulatory teams need is available at quotation stage.
Fenofibrate API — frequently asked questions
What is Fenofibrate API used for?
It is formulated into antilipemic medicines that lower elevated cholesterol and triglyceride levels, typically used alongside diet, exercise and, in some cases, statin therapy. This is general pharmacological context, not a claim about specific finished products manufactured by our customers.
What is the CAS number for Fenofibrate?
The CAS number for Fenofibrate is 49562-28-9.
Do you supply micronised Fenofibrate?
Micronised and defined particle-size grades are available on request. Because Fenofibrate is poorly water-soluble, particle size drives dissolution and bioavailability, so tell us your specification and we will confirm what we can supply.
What grades of Fenofibrate API do you supply?
IP, BP, USP and EP grades, against the applicable pharmacopoeial monograph, with micronised and defined particle-size options available on request.
Is a Certificate of Analysis provided with each batch?
Yes. A batch-wise Certificate of Analysis is issued as standard with every despatch, alongside the MSDS, specification sheet and method of analysis.
Is a DMF available for regulated markets?
DMF documentation is available on request — tell us your destination market and filing type and we will confirm what we can provide.
What is the minimum order quantity?
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.
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.