WHO-GMP sourced EU-GMP partners ISO 9001:2015 49+ export markets Since 2003

Griseofulvin, sold in the US as Gris-PEG and supplied generically across most other markets, is an oral first-line therapy for Microsporum-driven tinea capitis and other dermatophyte infections, and buyers can specify ultramicrosize, microsize or oral-suspension presentations against the same tender line.

Griseofulvin, an orally active antifungal first isolated from Penicillium moulds and marketed in the US as Gris-PEG (ultramicrosize) alongside generic tablets, remains a mainstay for tinea capitis, tinea corporis, tinea cruris, tinea pedis and tinea unguium caused by Trichophyton, Microsporum and Epidermophyton species. M Care Exports is a merchant exporter: we source Gris-PEG-equivalent ultramicrosize tablets and licensed generic microsize tablets and oral suspension through Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.

Also marketed as Grisactin, Grifulvin V and Fulvicin-U/F.

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WHO-GMP sourcing CDSCO licensed exporter EU-GMP capable partners Cold-chain validated (2–8°C & −25°C) CTD / eCTD dossier-ready ISO 9001:2015
Bulk supply and export terms

Griseofulvin exporter and bulk supplier from India.

Tell us the strength mix (125mg or 250mg ultramicrosize, 500mg microsize, or 125mg/5mL suspension), pack size and destination market, and we quote against your specification, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because griseofulvin courses run long, 2-4 weeks for tinea corporis up to 6 months for toenail onychomycosis, tender desks often need to plan continuity of supply across a full treatment cycle rather than a single dispatch, and we align pack quantities and re-order timing to that reality before releasing a quote. We 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.

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At a glance

Fungistatic antifungal antibiotic (microtubule/mitotic-spindle inhibitor), sourced and documented for export.

Griseofulvin is a fungistatic antibiotic that binds fungal microtubules and disrupts mitotic spindle formation, deposits in newly formed keratin, and so works from the inside out as new skin, hair and nail grow through. Its flagship licensed use, per the current US label, is ringworm infections of the body, groin, scalp, beard, feet and nails (tinea corporis, cruris, capitis, barbae, pedis and unguium) caused by Trichophyton, Microsporum and Epidermophyton species, when topical therapy is inappropriate or has failed; UK labelling for the licensed generic product carries the same dermatophytosis indication. It sits in a shrinking but genuine clinical niche: terbinafine and itraconazole have taken share for Trichophyton-driven adult tinea, but a meta-analysis of randomised trials found griseofulvin likely superior to terbinafine against Microsporum species, which keeps it in active use for paediatric tinea capitis in Microsporum-endemic regions. It is supplied as ultramicrosize tablets (125mg, 250mg), microsize tablets (500mg) and a 125mg/5mL oral suspension, taken with a fatty meal to raise absorption. Storage is ambient, 15-30°C in a tight, light-resistant container, with no cold-chain requirement.

Active ingredient

Griseofulvin. Fungistatic antifungal antibiotic (microtubule/mitotic-spindle inhibitor).

Forms and strengths

125 mg ultramicrosize tablet; 250 mg ultramicrosize tablet; 500 mg microsize tablet; 125 mg/5mL oral suspension.

Indications

Griseofulvin, marketed in the US as Gris-PEG (ultramicrosize) alongside generic tablets, is a fungistatic oral antibiotic indicated for dermatophyte infections of the skin, scalp, hair and nails caused by Trichophyton, Microsporum and Epidermophyton species. Supplied from Indian WHO-GMP facilities to regulated and semi-regulated export markets.

Administration

Oral. Tablet (ultramicrosize and microsize) and oral suspension.

Documentation

Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.

Who we supply

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 griseofulvin are hospital and community-dermatology pharmacists managing long dermatophyte treatment courses, paediatric departments and MoH tender desks running standard antifungal formulary lines (Microsporum-driven tinea capitis remains common in African and South Asian paediatric populations), licensed importers and wholesalers stocking routine antifungal ranges, and NGO or public-health procurement programmes supplying primary-care and school-health dermatophyte treatment in lower-resource settings where topical therapy alone is insufficient.

GCC registration routes

Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.

MoH registration, GCC →

UK unlicensed routes

Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.

MHRA Specials →

Tender desks

Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.

Tender response →

Dossier support

CTD documentation from the sourcing manufacturer, compiled for your regulator's format.

Dossier preparation →

Pharmacist's note

What the dispensing pharmacist checks on griseofulvin.

Griseofulvin absorption rises substantially with a fatty meal, so counsel patients to take it with milk or a meal containing fat rather than on an empty stomach, and confirm which particle-size product (ultramicrosize versus microsize) a formulary line specifies: ultramicrosize achieves roughly 1.5 times the absorption of microsize at the same nominal dose per the manufacturer's dosing guidance, and the two are not interchangeable milligram-for-milligram. Griseofulvin is contraindicated in pregnancy (conjoined-twin cases have been reported after first-trimester exposure), in porphyria and in hepatocellular failure, and it reduces warfarin's anticoagulant effect and can reduce combined oral contraceptive reliability, so flag both interactions on dispensing and advise a barrier method during treatment and for one month after the last dose. Photosensitivity reactions occur occasionally; advise patients to limit strong sun exposure. Courses are long, weeks for skin and scalp infections, four to six months for fingernails and at least six months for toenails, so continuity of supply across the full course matters more than for most anti-infectives.

Regulatory & quality

The documentation pack a regulator actually asks for.

Griseofulvin has sat on the WHO Model List of Essential Medicines since 1977 (antifungal medicines section, oral solid 125mg/250mg and oral liquid 125mg/5mL), and it carries no AWaRe classification because AWaRe applies to antibiotics used against bacteria, not antifungals. It is not a controlled substance under US, UK or WHO scheduling, and it needs no cold-chain handling: an ordinary ambient, light-controlled logistics lane covers it. On the brand-versus-generic question, the picture differs by market: in the US, the Gris-PEG ultramicrosize brand is still FDA-approved and marketed alongside generic ultramicrosize and microsize tablets, so buyers there have a genuine brand-or-generic choice; in the UK, current registrations on the emc are generic griseofulvin tablets (Brown & Burk UK Ltd) with no originator brand presently marketed, so UK tender lines are written generically by default. Buyers should specify particle size (ultramicrosize or microsize) on any tender or formulary line, since the two are not bioequivalent at the same nominal milligram dose and a straight brand-to-generic or microsize-to-ultramicrosize swap needs the prescribing team's sign-off, not a substitution made at the supply desk.

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.

How the enquiry works

Molecule · strength · volume · destination. One working day to a quote.

  1. Send us the specifics. Form and strength, pack preference, destination market and indicative volume for griseofulvin.
  2. We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
  3. Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
  4. Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
  5. After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Frequently asked

Griseofulvin supply, the specific questions.

What is griseofulvin licensed to treat?

Griseofulvin is licensed for dermatophyte (ringworm-type) fungal infections of the skin, scalp, hair and nails, specifically tinea corporis, tinea cruris, tinea capitis, tinea barbae, tinea pedis and tinea unguium (onychomycosis), where the causative organism is a Trichophyton, Microsporum or Epidermophyton species and topical antifungal therapy is inappropriate or has already failed. It is an oral therapy, not a topical cream.

How does griseofulvin compare with terbinafine for tinea capitis?

Both are effective, but the choice depends on which fungus is involved. Terbinafine clears Trichophyton-driven tinea capitis reliably in a shorter three-to-four-week course, but a meta-analysis of randomised trials found it performs worse against Microsporum species. Griseofulvin is likely superior to terbinafine against Microsporum, which is why it stays in active use in Microsporum-endemic paediatric populations even though its own course runs longer, typically four to six weeks for scalp infections.

Is griseofulvin safe in pregnancy or for patients trying to conceive?

No. Griseofulvin is contraindicated in pregnancy; conjoined-twin cases have been reported following first-trimester exposure in the published literature. It also reduces the reliability of combined oral contraceptives, so prescribers typically advise an additional barrier method during treatment and for one month after the last dose, and men are usually advised to avoid fathering a child for a defined period after treatment. This should be confirmed against the receiving country's current label.

What is the difference between ultramicrosize and microsize griseofulvin tablets?

Ultramicrosize griseofulvin has a smaller drug particle size that gives roughly one-and-a-half times the absorption of microsize griseofulvin at the same nominal milligram dose, which is why ultramicrosize products such as Gris-PEG can be dosed lower than older microsize tablets. The two are not interchangeable milligram-for-milligram, so tender and formulary lines should specify which particle-size product is required rather than treating griseofulvin as one interchangeable line.

Does griseofulvin need cold-chain storage, and is it a controlled substance?

No to both. Griseofulvin tablets and oral suspension are stored at normal room temperature, 15 to 30°C, in a tight, light-resistant container, and travel on standard ambient pharmaceutical logistics rather than validated cold-chain lanes. It is not scheduled as a controlled substance in the US, UK or under WHO drug-control conventions, so it does not carry the additional import-licensing burden that narcotics or psychotropics do.

Can M Care supply either the Gris-PEG brand or a generic griseofulvin line?

Yes, buyers can specify either. In the US, Gris-PEG (ultramicrosize) remains a marketed originator brand alongside FDA-approved generic ultramicrosize and microsize tablets. In the UK and most of the markets M Care serves, griseofulvin is currently supplied generically, with no originator brand in active distribution, so the standard tender line there is written generically. Tell us your destination market and we confirm which form the registration actually requires before quoting.

Sources and review

Who stands behind this page, and where its statements come from.

Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-13.

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.

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