Terbinafine, Indian WHO-GMP supply for dermatophyte and nail fungal infections.
Terbinafine covers two distinct procurement conversations under one molecule name. The 250mg oral tablet is a systemic prescription therapy for onychomycosis and tinea capitis that carries a hepatotoxicity label warning and needs liver-function screening before dispensing. The 1% topical cream, gel and spray are for interdigital and plantar tinea pedis, tinea cruris and tinea corporis, and in several of our export markets are available without prescription. Buyers asking us for "terbinafine" are usually asking for one of these two products, not both, and the regulatory file, the buyer type and the safety messaging differ enough that we handle them as separate supply lines rather than one generic SKU.
Terbinafine exporter and bulk supplier from India.
For tender desks and wholesale buyers evaluating terbinafine, tell us upfront whether you need the oral 250mg tablet, the topical 1% line, or both, along with your target country's registration status, because that determines which manufacturer in our network is the right fit and what documentation package you'll need for your own regulatory submission. We do not publish minimum order quantities, pricing or lead times on this page; those depend on formulation, pack size and destination-country registration status, so send us your specification and we'll come back with a sourced quote and documentation set rather than a generic estimate.
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.
Allylamine antifungal, sourced and documented for export.
Molecule: Terbinafine hydrochloride, allylamine-class antifungal. Oral form: 250mg tablets, once-daily systemic dosing, prescription-only in essentially every market we serve. Topical forms: 1% cream, gel and spray, twice-daily local application, OTC status varies by country. Core oral indications: toenail and fingernail onychomycosis, tinea capitis. Core topical indications: tinea pedis, tinea cruris, tinea corporis. Key safety flag on the oral line: hepatotoxicity, including rare cases of liver failure, transplant and death, has been reported in patients with and without pre-existing liver disease. Baseline and periodic liver function testing is standard label guidance, and terbinafine tablets are contraindicated in chronic or active liver disease. Not a scheduled or narcotics-controlled substance in the markets we export to; the regulatory hurdle is standard prescription-medicine registration, not narcotics control.
Active ingredient
Terbinafine hydrochloride. Allylamine antifungal.
Forms and strengths
250 mg (oral tablet); 1 % w/w (topical cream/gel/spray).
Indications
Terbinafine is an allylamine antifungal that inhibits squalene epoxidase, blocking ergosterol synthesis in the fungal cell membrane. The oral 250mg tablet is a systemic prescription therapy used for onychomycosis and tinea capitis and carries a hepatotoxicity label warning requiring baseline and periodic liver function monitoring. The 1% topical formulations (cream, gel, spray) are applied locally for tinea pedis, tinea cruris and tinea corporis, act with minimal systemic absorption, and are OTC-registered in a number of export markets, but have limited effectiveness against nail-plate infections.
Administration
Oral, Topical. Tablet (oral); Cream, gel and spray (topical).
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.
We source terbinafine tablets and topical formulations from WHO-GMP certified Indian manufacturers for licensed importers, hospital and tender procurement desks, and pharmaceutical wholesalers across the Gulf, Africa, the UK and EU, Southeast Asia and LATAM. Each shipment moves against the importer's own market authorisation and local labelling requirements; India is not a market we supply into. Because the oral tablet and the topical formulations sit under different registration dossiers and often different local prescribing rules, we handle enquiries for each as a separate sourcing conversation, and we ask early which formulation, strength and pack format a buyer's registration actually covers before quoting.
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 terbinafine.
The oral and topical terbinafine products are not interchangeable substitutes for each other, and procurement teams should treat them as such. Oral terbinafine is a systemic drug: it is contraindicated in patients with chronic or active liver disease, and prescribers are expected to check baseline serum transaminases (ALT/AST) before starting therapy and to monitor periodically during treatment, because hepatotoxicity, up to and including liver failure requiring transplant, has occurred in patients with no prior liver disease. Patients on the oral form are typically counselled to stop the drug and seek immediate evaluation if they develop persistent nausea, anorexia, fatigue, vomiting, right-upper-quadrant pain, jaundice, dark urine or pale stools. Terbinafine is a CYP2D6 inhibitor, so oral therapy has clinically relevant interactions with drugs metabolised through that pathway, including tricyclic antidepressants, SSRIs, beta-blockers, and monoamine oxidase type B inhibitors; rifampicin (a CYP inducer) can lower terbinafine exposure, while cimetidine can raise it. Taste and smell disturbance is a recognised adverse effect of oral terbinafine and, though uncommon, can be prolonged or in rare cases permanent, which is worth including in patient counselling material rather than omitting. Standard oral courses run roughly 6 weeks for fingernail onychomycosis and 12 weeks for toenail onychomycosis, with visible nail regrowth taking considerably longer than the treatment course itself because it tracks nail growth rate, not drug clearance. Topical terbinafine has a materially different profile: it is applied locally for periods as short as one to two weeks for interdigital or plantar tinea pedis, has negligible systemic absorption at labelled use, and does not carry the same hepatic monitoring requirement, though it does have poor efficacy against nail-plate infections because of limited penetration into the nail, so it should not be marketed or positioned as an onychomycosis treatment. Terbinafine is not a scheduled or narcotics-controlled substance in any of the markets we serve; import control is a standard prescription-medicine registration matter for the oral form, and in many jurisdictions the topical form is registered for OTC sale. Use in pregnancy and lactation should be left to the prescribing physician; we do not offer clinical dosing guidance on this page and buyers should rely on the product's own approved labelling and their national formulary.
The documentation pack a regulator actually asks for.
M Care Exports is an ISO 9001:2015 certified merchant-exporter; we do not manufacture terbinafine and do not hold WHO-GMP or WHO-PQ certification ourselves. Every batch we supply is sourced from WHO-GMP certified Indian manufacturers, and documentation (COA, GMP certificate, and where applicable free-sale certificates) is passed through to the importer for their own regulatory submission. Because oral and topical terbinafine are typically registered as separate products in destination markets, buyers should confirm which formulation their existing or planned market authorisation covers before we finalise sourcing.
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.
Oral 250mg tablet carries a hepatotoxicity label warning, including rare reports of liver failure, transplant and death; contraindicated in chronic or active liver disease
Baseline and periodic liver function testing is standard label guidance for the oral formulation
Oral terbinafine is a CYP2D6 inhibitor with clinically relevant drug interactions (tricyclics, SSRIs, beta-blockers, MAO-B inhibitors); rifampicin and cimetidine alter exposure
Not a scheduled or narcotics-controlled substance in any export market we serve; standard prescription-medicine registration applies to the oral form
Topical formulation has poor efficacy against nail-plate infections due to limited nail penetration and should not be positioned as an onychomycosis treatment
Adjacent lines procurement desks order alongside terbinafine.
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 terbinafine.
- 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.
Terbinafine supply, the specific questions.
Do you supply terbinafine tablets and terbinafine cream as the same product?
No. We treat oral 250mg tablets and the topical 1% cream, gel and spray line as separate sourcing conversations because they are usually registered as separate products in destination markets, have different prescribing status, and carry different safety documentation. Tell us which formulation your registration covers and we source accordingly.
Why does the oral tablet need liver function testing and the cream doesn't?
Oral terbinafine is absorbed systemically and carries a hepatotoxicity warning on its label, including rare reports of liver failure in patients with no prior liver disease, which is why baseline and periodic liver function testing is standard guidance and why the tablet is contraindicated in patients with chronic or active liver disease. The topical formulation acts locally with negligible systemic absorption at labelled use and does not carry that same monitoring requirement.
Is terbinafine a controlled or scheduled substance?
No. Terbinafine is not scheduled or narcotics-controlled in any of the markets we export to. The oral tablet requires standard prescription-medicine market authorisation in the destination country; the topical formulation is OTC-registered in a number of our export markets, though buyers should confirm status against their own country's schedule.
Can topical terbinafine be used to treat nail fungus instead of the tablet?
Topical terbinafine has limited effectiveness against onychomycosis because it penetrates the nail plate poorly. It is indicated for skin infections such as tinea pedis, tinea cruris and tinea corporis, not for nail infections, and we would flag this distinction to any buyer sourcing topical stock against a nail-fungus indication.
What drug interactions matter most for oral terbinafine procurement documentation?
Terbinafine inhibits CYP2D6, so it interacts with drugs cleared through that pathway, including tricyclic antidepressants, SSRIs, beta-blockers and MAO-B inhibitors. Rifampicin can reduce terbinafine exposure and cimetidine can increase it. This is prescriber-facing information relevant to the package insert and pharmacovigilance file your registration will need, not something we adjust the product for.
How long does an oral terbinafine course typically run for onychomycosis?
Published treatment courses run roughly 6 weeks for fingernail infections and 12 weeks for toenail infections, though visible nail regrowth takes considerably longer than the course itself since it follows the nail's own growth rate. We note this for context; treatment duration is a prescribing decision for the physician, not a claim we make about the product.
Do you supply into India?
No. We export terbinafine from India to licensed importers, wholesalers and tender desks abroad. India is not a market we serve.
What documentation comes with a terbinafine order?
Each batch is sourced from a WHO-GMP certified Indian manufacturer, and we pass through the certificate of analysis, GMP certificate, and free-sale certificate where applicable, so you have what's needed for your own national registration and import clearance. We do not hold WHO-GMP or WHO-PQ status ourselves; that certification sits with the manufacturer.
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.