Oral ketoconazole tablets have carried a suspended EU marketing authorisation since 2013, a restriction that splits where each of M Care's 33 stocked ketoconazole lines can legally land.
In July 2013 the European Medicines Agency recommended suspending the marketing authorisation of every oral ketoconazole product across the EU on hepatotoxicity grounds, while the FDA narrowed US labelling to endemic mycoses only, when alternatives fail or are not tolerated. Topical ketoconazole was untouched by either action. M Care stocks 26 oral tablet lines at 200mg strength and 6 topical lines in 15g, 20g and 30g pack sizes, and the two categories now face very different import realities depending on the destination market.
Ketoconazole exporter and bulk supplier from India.
Export documentation for ketoconazole follows the standard pharmaceutical merchant pack: certificate of analysis per batch, certificate of pharmaceutical product or free sale certificate on request, MSDS, and packing lists that separate tablet cartons from topical tubes. Given the divergent regulatory status of the oral form, we ask every new oral-tablet buyer to confirm their national marketing authorisation or import licence covers ketoconazole tablets before we proceed, rather than assuming clearance. Topical tubes (15g, 20g and 30g) ship on our standard topical-antifungal documentation; buyers should still confirm their own national import requirements, since these vary by destination market. Shipment volumes and consignment terms are confirmed per order once the buyer's licence position is established.
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.
Imidazole antifungal, sourced and documented for export.
Since 2013 the European Union has suspended every marketing authorisation for oral ketoconazole, while the FDA kept the tablet and narrowed it to endemic mycoses where nothing else is tolerated, so the same carton is importable into one destination and illegal in the next. The EU suspended marketing authorisations for oral ketoconazole outright that year, with the CHMP concluding that its hepatotoxicity is idiosyncratic (not reliably tied to dose or duration of treatment) and that the risk outweighed the clinical benefit given other antifungals were available. The FDA did not withdraw the oral tablet but confined it to endemic mycoses when other antifungals are unavailable or not tolerated, removing dermatophyte and nail indications from the US label entirely. Ketoconazole also inhibits adrenal and gonadal steroidogenesis and is a strong CYP3A4 inhibitor, both properties that predate and reinforce the 2013 actions. Topical ketoconazole (creams, shampoos) carries none of these restrictions and remains a standard first-line treatment for dermatophytosis, pityriasis versicolor and seborrhoeic dermatitis worldwide, which is why M Care's catalogue still carries both formats.
Active ingredient
Ketoconazole. Imidazole antifungal.
Forms and strengths
200 mg.
Indications
Ketoconazole is a synthetic imidazole antifungal active against dermatophytes, yeasts including Candida and Malassezia, and certain endemic dimorphic fungi. Oral ketoconazole's marketing authorisation was suspended EU-wide in 2013 on hepatotoxicity grounds and its US labelling was narrowed to endemic mycoses when alternatives are unavailable or not tolerated; topical ketoconazole was unaffected by either action and remains widely used for superficial fungal and seborrhoeic skin conditions.
Administration
Oral, Topical. Tablet and topical preparation.
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.
M Care supplies ketoconazole to licensed importers, hospital pharmacy tenders and regulatory affairs teams across the Gulf, Africa, Latin America, Southeast Asia and the CIS. Authorisation status for the oral tablet form varies by country following the 2013 EU and US label actions, so we work with each buyer to confirm their national regulator's current position before an oral order proceeds. UK and EU buyers approach us almost exclusively for the topical lines: creams and shampoos that were never part of the 2013 suspension and remain routine formulary items. Procurement teams in either region typically request the product dossier and current national registration status before confirming an order, and we provide both on request rather than assuming one applies everywhere.
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 ketoconazole.
A reviewing pharmacist checks two things before clearing an oral ketoconazole order: whether the destination country's own regulator still carries an active marketing authorisation for the oral tablet (the EU suspension is not automatically mirrored by every non-EU regulator, so status has to be confirmed per country, not assumed from the EU position), and the intended indication, since current labels in the markets that followed the EU and US actions have narrowed to endemic or systemic mycoses rather than superficial dermatophyte or nail infection, for which oral ketoconazole is no longer considered appropriate given safer alternatives. Baseline and periodic liver function monitoring is standard for any oral course. Because ketoconazole is a strong CYP3A4 inhibitor and inhibits adrenal corticosteroid synthesis, a co-medication and endocrine history review is routine, particularly for statins, certain benzodiazepines and corticosteroid-dependent patients. None of this monitoring guidance applies to the topical formulations, which are reviewed only for standard local skin tolerability.
The documentation pack a regulator actually asks for.
M Care is a merchant-exporter, not a manufacturer: ketoconazole is sourced from Indian manufacturing sites holding WHO-GMP certification, and M Care's own credentials are ISO 9001:2015 and a CDSCO export licence, which cover export documentation and quality management, not manufacturing GMP status. Standard documentation includes a certificate of analysis per batch, MSDS, and manufacturer GMP certificates or a certificate of pharmaceutical product where the destination regulator requires one. Given the 2013 EU suspension of oral ketoconazole marketing authorisations, buyers importing the tablet form should request confirmation of the manufacturing site's current registration status in their own jurisdiction rather than relying on EU precedent either way, since several non-EU regulators retained authorisation for oral ketoconazole after 2013 while others followed the EU's lead. Topical ketoconazole documentation follows the standard topical-antifungal dossier with no molecule-specific regulatory caveat beyond routine stability and microbial-limit data.
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.
EU marketing authorisations for oral ketoconazole were suspended EU-wide by CHMP recommendation in July 2013 on hepatotoxicity grounds; buyers must confirm current national status before ordering the tablet form.
FDA has restricted oral ketoconazole to endemic mycoses only, when alternative antifungal therapies are unavailable or not tolerated, and removed dermatophyte and nail indications from the US label.
Oral ketoconazole carries a boxed warning for hepatotoxicity, including reports of fatal and liver-transplant-requiring liver injury.
Ketoconazole inhibits adrenal and gonadal steroidogenesis and can cause adrenal insufficiency, particularly at higher doses or with hepatic impairment.
Ketoconazole is a strong CYP3A4 inhibitor with multiple contraindicated and dose-limiting drug interactions; co-medication review is required.
Oral ketoconazole is contraindicated in patients with acute or chronic liver disease.
Adjacent lines procurement desks order alongside ketoconazole.
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 ketoconazole.
- 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.
Ketoconazole supply, the specific questions.
Does M Care hold WHO-GMP or WHO-PQ certification directly?
No. M Care is a merchant-exporter, not a manufacturer, so it cannot hold WHO-GMP or WHO-PQ status itself. Ketoconazole is sourced from Indian manufacturing sites that hold WHO-GMP certification, and M Care's own credentials are ISO 9001:2015 and a CDSCO export licence covering export operations and documentation.
Can M Care supply oral ketoconazole tablets to buyers in the European Union?
The EU suspended marketing authorisations for oral ketoconazole products across all member states in 2013 on hepatotoxicity grounds. We ask EU buyers requesting the tablet form to confirm current national registration status before we proceed, since we will not assume clearance that the suspension may have removed. Our topical ketoconazole lines are unaffected and supply normally to EU buyers.
Why was oral ketoconazole restricted in 2013?
The EMA concluded that oral ketoconazole's hepatotoxicity is idiosyncratic, not reliably predicted by dose, duration or pre-treatment screening, and that this risk outweighed the clinical benefit given other antifungal treatments were available, so it suspended EU marketing authorisations. The FDA instead narrowed the US label to endemic mycoses only, when alternatives are unavailable or not tolerated, and removed dermatophyte and nail (onychomycosis) indications.
Is topical ketoconazole (cream, shampoo) affected by the 2013 restrictions?
No. The EU suspension and the FDA label narrowing applied only to oral ketoconazole. Topical formulations were not implicated in the hepatotoxicity signal and remain a standard, widely registered treatment for dermatophyte infections, pityriasis versicolor and seborrhoeic dermatitis in essentially every market M Care supplies.
What dosage forms and strengths does M Care stock for ketoconazole?
M Care stocks 33 ketoconazole lines across two formats: oral tablets at 200mg, and topical preparations supplied in 15g, 20g and 30g pack sizes. We do not stock ketoconazole capsules, injectable, oral suspension, ophthalmic, inhaled or sachet presentations, though we can advise on their clinical use if a buyer is comparing formats.
What documentation accompanies a ketoconazole export shipment?
Each shipment carries a certificate of analysis per batch, an MSDS, and manufacturer GMP documentation or a certificate of pharmaceutical product where the destination regulator requires one. For oral tablet orders we also request the buyer's own confirmation of current national marketing authorisation status before dispatch, given the divergent regulatory position since 2013.
Does oral ketoconazole require liver function monitoring during treatment?
Regulatory labelling in markets where the oral tablet remains authorised calls for baseline and periodic liver function assessment, reflecting the hepatotoxicity signal behind the 2013 EU suspension and FDA label narrowing. This is prescriber and clinical-pharmacist guidance, not an M Care recommendation; we supply against the buyer's own licensed use.
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.