Fucidin (fusidic acid) is a narrow-spectrum fusidane antibiotic for staphylococcal skin, bone and eye infections, tracked in WHO's AWaRe framework for antibiotic monitoring though not assigned to the Access, Watch or Reserve tiers, and licensed generic fusidic acid tablets, cream, ointment and eye drops are available alongside the originator brand outside the United States.
M Care Exports supplies Fucidin (fusidic acid), a fusidane-class antibiotic originated by LEO Pharma and marketed internationally as Fucidin, together with licensed generic fusidic acid tablets, cream, ointment and viscous eye drops. It targets staphylococcal skin, bone, joint and eye infections where broader-spectrum antibiotics are best held in reserve. M Care is a merchant exporter: we source Fucidin and generic fusidic acid lines through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Fusidic acid exporter and bulk supplier from India.
For hospital pharmacy, dermatology clinic and MoH tender-desk orders, M Care quotes fusidic acid against buyer specification: brand (Fucidin/Fucithalmic) or generic, tablet, cream, ointment or eye-drop format, and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because systemic Fucidin tablets carry a strict contraindication against co-administration with statins, we confirm the buyer's intended prescribing pathway and patient information leaflet 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.
Fusidane antibiotic; bacterial protein synthesis inhibitor (elongation factor G translocation), sourced and documented for export.
Fusidic acid is a fusidane-class antibiotic, structurally unrelated to other antibacterial groups, that inhibits bacterial protein synthesis by blocking the translocation of elongation factor G on the ribosome. Its spectrum is narrow and deliberately so: it targets Staphylococcus aureus, including many meticillin-resistant strains, and related Gram-positive organisms, which is why WHO tracks it under the AWaRe framework for antibiotic monitoring, outside the Access, Watch and Reserve tiers, rather than reaching for it as a first-line agent. The UK SmPC's flagship uses split by route: oral Fucidin tablets for staphylococcal osteomyelitis, septicaemia, endocarditis, pneumonia and deep wound infection; Fucidin cream and ointment for impetigo, folliculitis, sycosis barbae, paronychia and erythrasma; and Fucithalmic viscous eye drops for bacterial conjunctivitis, dosed just twice daily thanks to a sustained-release gel base, unlike the four-to-six-times-daily regimen typical of other topical ophthalmic antibiotics. Destination-country labelling should be checked against this before a quote is finalised. Fucidin is supplied as 250 mg film-coated tablets, 20 mg/g cream, 20 mg/g ointment and 1% w/w viscous eye drops.
Active ingredient
Fusidic acid (as sodium fusidate in the oral tablet). Fusidane antibiotic; bacterial protein synthesis inhibitor (elongation factor G translocation).
Forms and strengths
250 mg film-coated tablet; 20 mg/g cream; 20 mg/g ointment; 1 % w/w viscous eye drops.
Indications
Fusidic acid, a fusidane-class antibiotic narrowly targeted at Staphylococcus aureus and related Gram-positive organisms, licensed for staphylococcal skin, bone, joint and eye infections. Supplied as originator Fucidin/Fucithalmic and licensed generic lines from Indian WHO-GMP facilities to regulated and semi-regulated markets outside India and the United States.
Administration
Oral, Topical, Ophthalmic. Film-coated tablet, cream, ointment and viscous eye drops.
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 fusidic acid are hospital dermatology and orthopaedic pharmacies stocking a staphylococcal skin and bone-infection line, ophthalmology and A&E departments using Fucithalmic eye drops for bacterial conjunctivitis, national and regional MoH tender desks running anti-infective and antimicrobial-stewardship formulary lists, licensed pharmaceutical wholesalers and importers, and retail pharmacy chains across our GCC and African markets stocking a topical antistaphylococcal range where local scheduling permits.
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 fusidic acid.
Fucidin tablet dosing depends on severity: 250 mg (one tablet) sodium fusidate twice daily for cutaneous infections, rising to 500 mg three times daily, doubled in the most severe cases, for osteomyelitis, septicaemia or endocarditis, typically for five to ten days. The single most important prescribing check is the statin interaction: systemic Fucidin must not be co-administered with any HMG-CoA reductase inhibitor, because the combination has caused rhabdomyolysis, including fatal cases, and statin therapy should not resume until seven days after the course ends. Liver function should be monitored where hepatic impairment is suspected, since elevated transaminases and jaundice, usually reversible, have occurred during systemic therapy. Fucithalmic eye drops are dosed just twice daily, a sustained-release advantage over antibiotic eye drops that need four to six applications, but contact lenses must be removed for the duration of treatment. Topical cream and ointment courses should stay short: prolonged or repeated use invites resistant Staphylococcus aureus, precisely why WHO tracks fusidic acid under its AWaRe antibiotic-monitoring framework even though it sits outside the Access, Watch and Reserve tiers. No reconstitution and no cold-chain handling are required for any format.
The documentation pack a regulator actually asks for.
As oral, topical and ophthalmic dosage forms, fusidic acid travels on standard ambient-temperature logistics rather than the validated cold-chain lanes M Care runs for biologics; UK shelf life for tablets, cream, ointment and eye drops runs three years, with the eye-drop tube discarded one month after opening. 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. Fusidic acid was never listed on the WHO Model List of Essential Medicines, but WHO tracks it under the AWaRe classification for antibiotic monitoring, outside the Access, Watch and Reserve tiers, because its narrow anti-staphylococcal spectrum, including activity against many meticillin-resistant strains, makes it a stewardship-sensitive agent rather than a first-line antibiotic; tender desks running antimicrobial-stewardship formularies increasingly ask suppliers to confirm this status. On the brand-versus-generic question, Fucidin (tablets, cream, ointment), developed and marketed internationally by LEO Pharma, and Fucithalmic (eye drops), currently licensed in the UK by ADVANZ Pharma, remain the originator lines; licensed generic fusidic acid tablets, cream and eye drops from multiple manufacturers are separately registered and marketed in the UK, EU and across most GCC and African markets we serve, so buyers genuinely have a brand-or-generic choice. Fusidic acid has never been granted marketing approval in the United States, so no US-labelled originator or generic exists there; any US-linked enquiry should specify a destination outside the US before M Care quotes. It is not a controlled substance in the markets we currently review.
Buyers new to sourcing from India usually read the licensed import route explainer first, then the product page.
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 fusidic acid.
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 fusidic acid.
- 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.
Fusidic acid supply, the specific questions.
Does a generic version of Fucidin exist?
Yes, in most of our served markets. Licensed generic fusidic acid tablets, cream and eye drops from multiple manufacturers are registered alongside the originator Fucidin and Fucithalmic brands in the UK, EU and across most GCC and African markets M Care serves. Fusidic acid has never been approved in the United States, so no US-labelled brand or generic exists there; M Care checks destination-country registration before quoting brand or generic against a specific tender.
Why is fusidic acid not available in the United States?
Fusidic acid has never received FDA marketing approval, despite decades of use in the UK, Europe, GCC states and across Africa. Development efforts to bring it to the US market have not resulted in an approved product, so there is no US-labelled Fucidin brand or generic. M Care supplies fusidic acid only into markets outside the United States where the product carries local or regional registration.
What strengths and forms of fusidic acid does M Care supply?
250 mg film-coated tablets (as sodium fusidate) for staphylococcal infections, 20 mg/g cream and 20 mg/g ointment for skin infections, and 1% w/w viscous eye drops for bacterial conjunctivitis, matching the Fucidin and Fucithalmic formats. Tell us your buyer mix, hospital, dermatology, ophthalmology or retail formulary, and we quote the strength and pack format accordingly.
Can fusidic acid tablets be given alongside statin therapy?
No. Systemic Fucidin tablets must not be co-administered with any statin (HMG-CoA reductase inhibitor); the combination has caused rhabdomyolysis, including fatal cases. Statin therapy should be paused for the course and not restarted until seven days after fusidic acid treatment ends. This interaction should be flagged clearly on any dispensing record and formulary listing.
Is fusidic acid on the WHO Essential Medicines List?
No. Fusidic acid has never been listed on the WHO Model List of Essential Medicines, but WHO tracks it under the AWaRe classification for antibiotic monitoring, outside the Access, Watch and Reserve tiers, because of its narrow, staphylococcus-targeted spectrum, including activity against many meticillin-resistant strains. Tender desks running antimicrobial-stewardship formularies typically flag fusidic acid as a stewardship-sensitive agent rather than a first-line EML antibiotic.
Why are the Fucithalmic eye drops dosed only twice daily?
Fucithalmic viscous eye drops use a sustained-release gel base that maintains therapeutic fusidic acid concentrations in ocular tissue for longer than a standard solution, so twice-daily dosing is sufficient for bacterial conjunctivitis, compared with the four-to-six-times-daily regimen typical of other topical ophthalmic antibiotics. Treatment should continue for at least 48 hours after the eye appears normal, and contact lenses should not be worn during the course.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-14.
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.