Monuril/Monurol (oral) and Fomicyt (intravenous) fosfomycin are licensed for uncomplicated cystitis and for serious multidrug-resistant infection respectively, and buyers can specify the originator brand or a licensed generic line against the same tender.
M Care Exports is a merchant exporter of fosfomycin, a phosphonic acid antibacterial marketed as oral Monuril (branded Monurol in the United States) and, in an intravenous formulation, as Fomicyt. We source both the originator brand and licensed generic fosfomycin lines through Indian WHO-GMP manufacturing and distribution channels, and dispatch against a buyer's specification rather than from our own manufacturing.
Fosfomycin exporter and bulk supplier from India.
For hospital pharmacy, wholesaler and MoH tender orders, M Care quotes fosfomycin against buyer specification: oral fosfomycin tromethamine as a single 3 g granules-for-oral-solution sachet (Monuril/Monurol or a licensed generic), and intravenous disodium fosfomycin as 2 g, 4 g or 8 g powder-for-infusion vials (Fomicyt or a licensed generic), sourced from licensed WHO-GMP manufacturer lines on the M Care roster. Because the oral sachet and the IV vial are separate dosage forms with separate licensed indications, and current UK and EU labelling requires intravenous fosfomycin to be given only as part of a combination antibacterial regimen, we confirm the exact dosage form, strength split and destination-market labelling a tender line specifies before we release a quote, 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.
Phosphonic acid derivative antibacterial, sourced and documented for export.
Fosfomycin is a phosphonic acid derivative antibacterial that blocks an early step in bacterial cell-wall synthesis, an action distinct from the beta-lactams and fluoroquinolones it is often used alongside or in place of, which is part of why it retains activity against many multidrug-resistant Gram-negative organisms. The oral form, fosfomycin tromethamine, is licensed in the US as Monurol and across the UK and EU as Monuril, for uncomplicated urinary tract infection (acute cystitis) in women caused by susceptible Escherichia coli and Enterococcus faecalis, given as a single 3 g sachet dissolved in water, and Monuril also carries a licensed indication for perioperative antibacterial prophylaxis before transrectal prostate biopsy; it is not licensed for pyelonephritis or perinephric abscess. The intravenous form, disodium fosfomycin, is licensed in the EU as Fomicyt across all age groups for serious infections, including complicated urinary tract infection, hospital-acquired pneumonia, bone and joint infection, skin and soft-tissue infection, endocarditis, meningitis, intra-abdominal infection and associated bacteraemia, where standard first-line agents are considered inappropriate. Adult IV dosing typically runs 12 to 24 g a day in divided doses for patients with near-normal renal function, adjusted down substantially as creatinine clearance falls, with a single dose capped at 8 g. Current EU and UK labelling for the IV form specifies it should be given as part of a combination antibacterial regimen, to reduce the risk of selecting for resistance.
Active ingredient
Fosfomycin (as fosfomycin tromethamine, oral; as disodium fosfomycin, intravenous). Phosphonic acid derivative antibacterial.
Forms and strengths
3 g granules for oral solution sachet; 2 g powder for solution for infusion vial; 4 g powder for solution for infusion vial; 8 g powder for solution for infusion vial.
Indications
Fosfomycin, a phosphonic acid antibacterial that inhibits early bacterial cell-wall synthesis, supplied as oral fosfomycin tromethamine (Monuril/Monurol) for uncomplicated cystitis and as intravenous disodium fosfomycin (Fomicyt) for serious multidrug-resistant infection.
Administration
oral, intravenous. Granules for oral solution (single-dose sachet); powder for solution for infusion (vial).
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 fosfomycin are hospital pharmacists stocking a reserve-tier intravenous option for multidrug-resistant Gram-negative infection when first-choice agents are unsuitable, primary and community pharmacies and urology outpatient services dispensing the single-dose oral sachet for uncomplicated cystitis, national and regional MoH tender desks specifying fosfomycin against antimicrobial-stewardship-restricted or reserve-antibiotic tender lines, licensed pharmaceutical wholesalers and importers maintaining a broad-spectrum anti-infective range, and infectious-disease and urology services managing recurrent or resistant urinary tract infection.
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 fosfomycin.
Oral and intravenous fosfomycin are dosed on entirely different scales, and mixing them up on a drug chart is an easy error: the oral sachet is a single 3 g dose for uncomplicated cystitis, with no repeat dosing needed, while the intravenous form for serious infection runs 12 to 24 g a day in divided doses, capped at 8 g per single dose, and needs stepped-down dosing as creatinine clearance falls. Reconstitute the IV powder for infusion as the SmPC directs and infuse over at least 15 to 60 minutes depending on pack size; the diluted solution holds for 24 hours at 25°C protected from light. Each gram of intravenous fosfomycin carries roughly 320 mg of sodium, so patients with heart failure or renal impairment need sodium and potassium monitoring across a course. Current EU and UK labelling requires the IV form to be given as part of a combination antibacterial regimen, never as monotherapy, specifically to reduce the risk of selecting for resistance during treatment.
The documentation pack a regulator actually asks for.
Both dosage forms ship at room temperature with no cold-chain requirement, so M Care's documentation chain runs the standard non-biologic export file: batch-specific certificate of analysis, WHO-GMP manufacturing site documentation from the sourcing partner, and CDSCO (Central Drugs Standard Control Organization, India) export paperwork from the Mumbai desk, with CTD/eCTD dossier support for destination markets such as MHRA, SFDA, MOHAP, NAFDAC, PPB or SAHPRA that require local registration or tender-listing documentation before import. Fosfomycin does not appear on the WHO Essential Medicines List core or complementary lists, but the WHO AWaRe antimicrobial-stewardship framework classifies the oral form as WATCH and the intravenous form as RESERVE, the tier WHO reserves for last-resort agents against multidrug-resistant organisms, which buyers running stewardship-linked tender specifications should factor into procurement. On brand versus generic: Monuril, Monurol and Fomicyt are separate marketing authorisations held by their respective current authorisation holders in each market. A licensed generic fosfomycin tromethamine oral sachet is registered in the US alongside the Monurol brand; buyers with a formulary or tender preference for the originator brand or a licensed generic line genuinely have that choice for the oral form, and we confirm current generic registration status for the intravenous form against the destination market before quoting. We do not manufacture fosfomycin ourselves and hold no WHO-GMP or WHO-PQ certification in our own name; every batch we export carries its manufacturing partner's own certification.
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 fosfomycin.
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 fosfomycin.
- 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.
Fosfomycin supply, the specific questions.
What is the difference between oral fosfomycin (Monuril/Monurol) and intravenous fosfomycin (Fomicyt)?
Oral fosfomycin tromethamine, marketed as Monuril in the UK and EU and Monurol in the US, is licensed for uncomplicated urinary tract infection (acute cystitis) in women, given as a single 3 g sachet, and Monuril also carries a licensed indication for perioperative antibacterial prophylaxis before transrectal prostate biopsy in some markets. Intravenous disodium fosfomycin, marketed in the EU as Fomicyt, is licensed across all age groups for serious infections, including complicated urinary tract infection, bone and joint infection, hospital-acquired pneumonia and bacteraemia, when standard first-line agents are considered inappropriate, dosed at 12 to 24 g a day in divided doses. They are separate registrations, separate dosage forms and not interchangeable.
Is there a generic version of Monurol or Monuril?
Yes for the oral form in the US: a licensed generic fosfomycin tromethamine granules-for-oral-solution product is registered alongside the Monurol brand. M Care can source either the originator brand or a licensed generic oral sachet, depending on what a tender or formulary specification requires; we confirm current generic registration status for the intravenous Fomicyt formulation against the destination market before quoting, since generic entry varies more by country for the IV form.
Is fosfomycin on the WHO Essential Medicines List?
No, fosfomycin does not currently appear on the WHO Essential Medicines List. It is, however, tracked under the WHO AWaRe antimicrobial-stewardship classification: the oral form sits in the WATCH group and the intravenous form sits in the RESERVE group, the category WHO reserves for last-resort agents against multidrug-resistant infection. Buyers running stewardship-linked or reserve-antibiotic tender lines should specify the dosage form accordingly, since the two forms carry different AWaRe tiers.
Why must intravenous fosfomycin be given with another antibiotic?
Current EU and UK labelling for intravenous fosfomycin states it should be given as part of a combination antibacterial drug regimen rather than as monotherapy. The requirement was added following the European Medicines Agency's 2020 review of fosfomycin-containing medicines, specifically to reduce the risk of selecting for antibiotic resistance during treatment. Hospital pharmacies and prescribers should build this into protocol and formulary guidance rather than treating fosfomycin as a standalone agent for serious infection.
What is the sodium-content concern with intravenous fosfomycin?
Disodium fosfomycin carries a high sodium load of approximately 320 mg per gram of active fosfomycin, so a typical adult dose of 12 to 24 g a day delivers a substantial daily sodium quantity. Current labelling calls for monitoring of sodium and potassium levels, particularly in patients with heart failure or renal impairment, across a treatment course. This is a standard checkpoint for hospital pharmacies building an infusion protocol or reviewing a patient's fluid and electrolyte balance.
What strengths and dosage forms of fosfomycin can M Care supply?
Oral fosfomycin tromethamine as a single 3 g granules-for-oral-solution sachet, matching the Monuril/Monurol presentation and the equivalent licensed US generic, and intravenous disodium fosfomycin as 2 g, 4 g or 8 g powder-for-infusion vials, matching the Fomicyt presentation. Tell us your dosing protocol, indication mix and destination market and we quote the split accordingly.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-19.
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.