Fenofibrate strengths are not interchangeable milligram for milligram, and M Care sources tablets and capsules matched to the exact reference formulation your dossier requires.
Fenofibrate is not a single interchangeable dose. Different reference formulations use different particle-size and bioavailability-enhancement technology to reach a comparable fenofibric acid blood level, so a 145mg tablet is not the same dose as a 160mg tablet or a 200mg capsule from a different product family, even though all are labelled fenofibrate. M Care sources fenofibrate tablets and capsules matched to the strength and formulation your regulatory dossier already references, not a generic mg-for-mg substitute, from WHO-GMP certified Indian manufacturers.
Fenofibrate exporter and bulk supplier from India.
Export documentation for fenofibrate states the strength, dosage form (tablet or capsule) and the specific product line by name, since M Care carries strengths from more than one non-interchangeable formulation convention side by side and these are not substitutable on a purchase order. One catalogue line, sold under the brand Adilip at 45mg and 135mg, follows the choline fenofibrate (fenofibric acid) strength convention rather than the fenofibrate one; M Care confirms the exact salt on the proforma invoice before this line is registered or dispatched, and it is never treated as interchangeable with the 145mg, 160mg or 200mg fenofibrate lines. Each shipment ships with a batch-specific certificate of analysis, a certificate of pharmaceutical product or free sale certificate as required by the destination regulator, and stability data appropriate to solid oral dosage forms. Packing is standard blister or alu-alu strip in export cartons; no cold chain is required. Buyers should confirm the reference product their dossier names before ordering.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
Fibric acid derivative, PPAR-alpha agonist, sourced and documented for export.
Fenofibrate's label strength is tied to the specific product formulation, not fixed across brands. Different fenofibrate products use different particle-size and bioavailability-enhancement technology (micronized, nanocrystallized and other particle-reduction methods) to reach a comparable fenofibric acid blood level, so several non-interchangeable strength families exist for what is chemically one drug. The 145mg nanocrystallized-tablet strength, for example, is bioequivalent to the older 160mg micronized tablet and to the 200mg micronized capsule, not to any other strength at a similar number. M Care's fenofibrate catalogue spans 33 lines in oral tablet or capsule form, built predominantly on this 145mg, 160mg and 200mg family. One brand in the catalogue, Adilip, is listed at 45mg and 135mg instead: that pairing is the strength convention for choline fenofibrate (fenofibric acid), a related but distinct active ingredient, so M Care confirms the exact salt on the proforma invoice before this line is registered or offered as a substitute for any fenofibrate strength. Fenofibrate itself is a PPAR-alpha agonist used for hypertriglyceridemia and mixed dyslipidemia, prodrug-metabolised to fenofibric acid, and every line in this catalogue is monotherapy: none are fixed-dose combinations.
Active ingredient
Fenofibrate. Fibric acid derivative, PPAR-alpha agonist.
Forms and strengths
45 mg; 135 mg; 145 mg; 160 mg; 200 mg.
Indications
Fenofibrate is an oral fibric acid derivative and PPAR-alpha agonist, hydrolysed after absorption to its active metabolite fenofibric acid, indicated for hypertriglyceridemia and mixed dyslipidemia as an adjunct to diet. Different fenofibrate formulations use different particle-size and bioavailability-enhancement technology, so the same clinical strength is expressed as different milligram figures (145mg, 160mg or 200mg) depending on the reference product, and doses are not interchangeable on a straight milligram-for-milligram basis across formulations. One catalogue line is listed at 45mg and 135mg, the strength convention used for choline fenofibrate (fenofibric acid) rather than fenofibrate itself; its exact salt is confirmed before dispatch.
Administration
Oral. Tablet, Capsule.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Buyers are regulatory affairs teams and licensed importers in the UK and EU, Gulf and GCC tender desks, African and Latin American distributors, and procurement offices in Southeast Asia and CIS states building or refreshing a lipid-lowering tender line. Hospital and institutional procurement ask for fenofibrate when a formulary already carries a specific reference strength and needs a matched, re-supply source rather than a substitute dose. Regulatory affairs staff preparing a marketing authorisation or tender dossier for a new market are the other core buyer, since the reference formulation named in that dossier determines which strength they can actually order. India is the country of manufacture only, not a served market.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on fenofibrate.
A reviewing pharmacist should confirm which reference formulation a given strength is bioequivalent to before treating it as a substitute for another fenofibrate line already on formulary, since different particle-size and bioavailability-enhancement conventions are not dose-equivalent milligram for milligram. The catalogue's 45mg and 135mg line (brand Adilip) follows the choline fenofibrate (fenofibric acid) strength convention, a distinct active ingredient from fenofibrate, and its exact salt should be confirmed against the certificate of analysis before it is registered, prescribed or substituted for any fenofibrate-labelled product. Fenofibrate is contraindicated in severe renal impairment (including dialysis), in active or hepatic liver disease (including primary biliary cirrhosis and unexplained persistent liver function abnormality), and in preexisting gallbladder disease. Liver function should be checked at baseline and monitored periodically during therapy, and renal function should be tracked since fenofibrate can cause a reversible rise in serum creatinine. Myopathy and rhabdomyolysis risk rises when fenofibrate is co-administered with a statin, and risk factors include age, hypothyroidism and renal impairment. Fenofibrate potentiates oral anticoagulants and should be separated in time from bile acid sequestrants, which impair its absorption. Some formulations require administration with food to reach labelled bioavailability; this varies by product and should be checked against the specific line's label, not assumed.
The documentation pack a regulator actually asks for.
Each fenofibrate line ships with a batch-specific certificate of analysis, a certificate of pharmaceutical product or free sale certificate for the destination regulator, and stability data for the solid oral dosage form supplied. Because fenofibrate strengths are formulation-specific, dossier packs identify the exact reference product a given line is bioequivalent to, not just the milligram figure, so importers can bridge it correctly against their existing marketing authorisation or tender specification. The catalogue's 45mg and 135mg line is confirmed by salt, as choline fenofibrate (fenofibric acid) rather than fenofibrate, before it is referenced in any registration dossier or tender submission. M Care sources every line from WHO-GMP certified Indian manufacturers and can pass through the manufacturer's GMP certificate and manufacturing site details on request. M Care's own credentials are ISO 9001:2015 quality management certification and a CDSCO export licence; M Care is a merchant-exporter and does not hold WHO-GMP or WHO-PQ status itself, and does not represent otherwise in any tender submission.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
What a buyer should know before this line enters a formulary.
We publish the awkward facts alongside the useful ones. A supplier who omits them is not saving you work, only deferring it.
Fenofibrate is contraindicated in severe renal impairment, including dialysis
Fenofibrate is contraindicated in active or hepatic liver disease, including primary biliary cirrhosis and unexplained persistent liver function abnormality
Fenofibrate is contraindicated in preexisting gallbladder disease
Increased myopathy and rhabdomyolysis risk when co-administered with a statin
Fenofibrate strengths are formulation-specific (micronized versus nanocrystallized) and not interchangeable milligram for milligram across products
Fenofibrate potentiates oral anticoagulants; separate dosing from bile acid sequestrants
Adjacent lines procurement desks order alongside fenofibrate.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for fenofibrate.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Fenofibrate supply, the specific questions.
Why are fenofibrate strengths like 145mg and 160mg not interchangeable?
Fenofibrate formulations use different particle-size technology (micronized versus nanocrystallized) to reach the same fenofibric acid blood level, so the milligram figure alone does not indicate equivalence. A 145mg nanocrystallized tablet and a 160mg micronized tablet can be clinically comparable, but a straight substitution without checking the reference formulation is not safe practice for a dossier or a tender specification.
Why do some catalogue lines show fenofibrate at 45mg and 135mg instead of 145mg, 160mg or 200mg?
Those strengths, carried under the brand Adilip, follow the strength convention used for choline fenofibrate (fenofibric acid), a related but distinct active pharmaceutical ingredient from fenofibrate, rather than the 145mg, 160mg and 200mg fenofibrate convention described above. M Care confirms the exact salt against the certificate of analysis and states it on the proforma invoice before this line is registered with a regulator or offered against any other strength in this catalogue, so it should never be assumed interchangeable with a fenofibrate-labelled specification without that confirmation.
Does M Care hold WHO-GMP or WHO-PQ certification directly?
No. M Care is a merchant-exporter, not a manufacturer, and does not hold WHO-GMP or WHO-PQ certification itself. Fenofibrate lines are sourced from WHO-GMP certified Indian manufacturers, and the manufacturer's GMP certificate and site documentation can be passed through to buyers on request. M Care's own credentials are ISO 9001:2015 and a CDSCO export licence.
Which fenofibrate dosage forms does M Care actually stock?
M Care's fenofibrate catalogue is oral tablets and capsules only, across 33 lines. Most lines are labelled 145mg, 160mg or 200mg; one brand line is listed at 45mg and 135mg following the fenofibric acid convention, with the exact salt confirmed before dispatch (see above). M Care does not stock fenofibrate injection, oral suspension, or any topical, ophthalmic, inhaled or sachet form; these formats are not part of the current line list and no availability claim is made for them.
What should a dossier or purchase order specify to avoid a strength mismatch?
Name the exact strength, dosage form and product line, not just fenofibrate and a milligram figure. Because M Care's catalogue spans more than one strength convention, including the fenofibric acid convention at 45mg and 135mg, the purchase order should reference the specific reference formulation the buyer's marketing authorisation or tender document already cites and request salt confirmation on the proforma invoice where relevant, so the shipped line bridges correctly.
What renal, hepatic and gallbladder precautions apply to fenofibrate before shipment or reorder?
Fenofibrate is contraindicated in severe renal impairment, including dialysis, in active or hepatic liver disease including primary biliary cirrhosis and unexplained persistent liver function abnormality, and in preexisting gallbladder disease, and can cause a reversible rise in serum creatinine during use. These are prescribing and monitoring considerations for the importer's own regulatory and clinical teams; M Care does not provide patient-level dosing guidance.
What export documentation accompanies a fenofibrate shipment?
Each batch ships with a certificate of analysis specific to that batch, a certificate of pharmaceutical product or free sale certificate as the destination regulator requires, and stability data for the solid oral dosage form. Manufacturer GMP certification is available on request to support the importer's own registration file.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-22.
This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.
Send the specifics. You'll have a price inside one working day.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.
