Daktarin (miconazole), sold in the US as Monistat, is licensed across skin, oral and vaginal candidiasis, and licensed generic miconazole cream, oral gel and pessaries are available alongside the originator brand.
M Care Exports supplies Daktarin (miconazole), an imidazole antifungal originated by Janssen and marketed today by McNeil (UK oral gel and cream) and, in the US vaginal segment, by Insight Pharmaceuticals as Monistat, alongside FDA- and MHRA-licensed generic miconazole lines. It treats fungal skin infections, oral thrush and vaginal candidiasis across three distinct dosage forms. M Care is a merchant exporter: we source Daktarin/Monistat and generic miconazole through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Miconazole exporter and bulk supplier from India.
For hospital pharmacy, wholesaler and retail-chain orders, M Care quotes miconazole against buyer specification: brand (Daktarin/Monistat) or generic, cream, oral gel or vaginal cream/insert, and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because the oral gel carries an infant choking warning and a clinically significant warfarin interaction not shared by the topical cream, we confirm the buyer's intended dosage form and patient population before dispatch, then align CTD/eCTD or country-specific dossier paperwork to the destination regulator's requirements.
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.
Miconazole is an imidazole-class antifungal that inhibits fungal cytochrome P450 14-alpha-demethylase, blocking ergosterol synthesis and disrupting the fungal cell membrane; at higher concentrations it is also fungicidal. It is dosed topically or locally, never injected, and needs no reconstitution. The MHRA-approved oral gel (20 mg per gram) is licensed for oropharyngeal candidosis in adults, children and infants from 4 months; the 2% cream is licensed for fungal skin and nail infections, including secondary bacterial infection with gram-positive organisms; and, in the US, Monistat vaginal formulations (miconazole nitrate 4% cream for a 3-night regimen, or a single 1200 mg vaginal insert) treat vulvovaginal candidiasis. Destination-country labelling should be checked against this before a quote is finalised. Daktarin is supplied as oral gel, cream and, regionally, pessaries; Monistat is supplied as vaginal cream (3- and 7-night regimens) and a single-dose vaginal insert (1-day regimen).
Active ingredient
Miconazole nitrate. Imidazole antifungal.
Forms and strengths
2 % w/w cream; 20 mg/g oral gel; 4 % w/w vaginal cream.
Indications
Miconazole, an imidazole antifungal indicated across fungal skin infection, oropharyngeal candidosis and vulvovaginal candidiasis. Supplied as originator Daktarin/Monistat and licensed generic formulations from Indian WHO-GMP facilities to regulated and semi-regulated markets outside India.
Administration
Topical, Oromucosal, Vaginal. Cream, oral gel, vaginal cream and vaginal insert.
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 for miconazole are mainly hospital and community pharmacies dispensing for oral and skin candidiasis, obstetrics and gynaecology outpatient clinics managing vulvovaginal candidiasis, national and regional MoH tender desks running dermatology and women's-health formulary lists, licensed pharmaceutical wholesalers and importers, and NGO or foundation procurement programmes supporting maternal and reproductive health access in markets where local registration is in place.
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 miconazole.
Miconazole's three licensed dosage forms carry different risk profiles that pack-mix planning should reflect. Oral gel is contraindicated in liver disease and carries an infant choking warning: the gel must not be applied to the back of the throat and should be worked into the mouth in small portions with a clean finger, not swallowed as a bolus. The UK SmPC doses infants aged 4 to 24 months at 1.25 ml (a quarter measuring spoon) four times daily after meals. It also carries a clinically significant interaction with warfarin and other vitamin K antagonists, with UK labelling requiring INR monitoring and reports of serious, sometimes fatal, bleeding on concomitant use; the same caution applies to oral hypoglycaemics and phenytoin. The gel contains benzyl alcohol, so UK labelling advises against use in neonates under four weeks. The topical cream carries a milder version of the warfarin caution but no infant restriction. None of the three forms requires cold-chain handling or reconstitution; all are stored below 25-30 degrees C, and typical shelf life at dispatch is 24 months unopened for the cream and 3 years for the oral gel.
The documentation pack a regulator actually asks for.
As topical, oromucosal and vaginal dosage forms, miconazole travels on standard ambient-temperature logistics rather than the cold-chain lanes M Care validates for biologics and insulins. What buyers need instead is batch-level certificate of analysis, CDSCO export documentation and, where the destination market requires it, CTD or eCTD-format dossier support so the buyer's own regulator can register the product. Topical miconazole nitrate (2% cream/ointment) has featured on WHO Model Lists of Essential Medicines as a first-line dermatological antifungal, reflecting its established role in fungal skin infection management in resource-limited settings; buyers building an EML-aligned tender specification should confirm current listing against their own national essential-medicines list. On the brand-versus-generic question, Daktarin remains the originator brand in the UK and much of Europe (McNeil), and Monistat the originator brand in the US vaginal segment (Insight Pharmaceuticals), while FDA- and MHRA-approved generic miconazole cream, oral gel and vaginal formulations from multiple manufacturers are separately registered in the US, UK and EU, so buyers genuinely have a brand-or-generic choice across all three dosage forms.
Permit sequence, registration status and customs handling are documented in importing medicines from India through the licensed route; this page sticks to what is specific to the molecule.
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.
Adjacent lines procurement desks order alongside miconazole.
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 miconazole.
- 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.
Miconazole supply, the specific questions.
Does a generic version of Daktarin or Monistat exist?
Yes. FDA- and MHRA-approved generic miconazole cream, oral gel and vaginal formulations are registered and marketed in the US, UK and EU alongside the originator brands Daktarin and Monistat. Registration status varies by destination country and dosage form, so M Care checks local approval before quoting brand or generic against a specific tender.
Can M Care supply Daktarin or Monistat to our market?
Yes, on an import basis. We source Daktarin through McNeil's and Monistat through Insight Pharmaceuticals' licensed Indian distribution channels and dispatch against your import authorisation and any local registration your pharmacy, hospital or wholesaler holds.
What dosage forms of miconazole are available?
Oral gel (20 mg per gram, for oropharyngeal candidosis from 4 months), 2% cream (for fungal skin and nail infections), and, regionally, vaginal cream and a single-dose vaginal insert for vulvovaginal candidiasis. Tell us your indication and destination market and we quote the matching dosage form.
Is miconazole oral gel safe to use with warfarin?
Not without monitoring. Miconazole oral gel has a clinically significant interaction with warfarin and other vitamin K antagonists; UK labelling requires careful INR monitoring during concomitant use because of reports of serious bleeding. This warning should be flagged clearly on any dispensing record for a patient on anticoagulant therapy.
Can miconazole oral gel be given to infants?
UK labelling permits use from 4 months of age, dosed at 1.25 ml four times daily for infants aged 4 to 24 months. The gel must not be applied to the back of the throat because of a choking risk, and it contains benzyl alcohol, so UK labelling advises against use in neonates under four weeks.
What documentation does M Care provide with a miconazole shipment?
Batch-level certificate of analysis, CDSCO export documentation from the Indian side, and CTD/eCTD-aligned dossier support where the destination regulator requires local registration. We confirm the specific dosage form's regulatory pack against your market's requirements before dispatch.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-25.
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.