MONUROL 3 G — DIN 02240335
FOSFOMYCIN (FOSFOMYCIN TROMETHAMINE) : 3 G · ENDO OPERATIONS LTD. · POWDER FOR SOLUTION · wholesale supply in Canada
Health Canada status: MARKETED
What is MONUROL?
MONUROL 3 G contains FOSFOMYCIN (FOSFOMYCIN TROMETHAMINE) : 3 G. It is listed in the Health Canada Drug Product Database under DIN 02240335, held by ENDO OPERATIONS LTD., supplied as POWDER FOR SOLUTION for ORAL administration. Health Canada currently lists it as marketed, status dated 01-Apr-2026. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is MONUROL used for?
Treatment of acute uncomplicated lower urinary tract infections (acute cystitis) in women 18+ years caused by E. coli or E. faecalis. Not for pyelonephritis.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Fosfomycin cost around the world?
Fosfomycin is listed on 8 of the national price registers Nexara ingests. Each country publishes on a different basis, so those figures are not comparable with one another — or with a Canadian wholesale price.
What a market publishes matters more than the number it publishes. Bahrain publishes a retail (max); Greece publishes a producer price (ex-factory); Iceland publishes a max wholesale. Comparing an ex-factory ceiling against a pharmacy public price tells you nothing about either, and comparing either against a Canadian landed cost tells you less.
| Market | Price basis published there | Brands | Packs listed | Range |
|---|---|---|---|---|
| United States | acquisition | 1 | 10 | USD███.██ |
| South Africa | single exit price | 10 | 10 | ZAR███.██ |
| Saudi Arabia | public | 5 | 7 | SAR███.██ |
| Greece | producer price (ex-factory) | 3 | 3 | EUR███.██ |
| Romania | max producer price | 2 | 2 | RON███.██ |
| Bahrain | retail (max) | 1 | 1 | BHD███.██ |
| United Kingdom | hospital | 1 | 1 | GBP███.██ |
| Iceland | max wholesale | 1 | 1 | ISK███.██ |
35 pack listings across 24 brand entries and 8 price bases, refreshed 03 Sep 2026. Ranges span every Fosfomycin pack in that market, so a high figure is usually a larger pack rather than the same product.
Canada publishes no comparable public list price. For a delivered Canadian price on a licensed account, verify your licence — it takes about a minute.
Is there a generic Fosfomycin in Canada, and who makes it?
Every market authorization holder with a Canadian DIN for this molecule, and how many of their listings Health Canada currently shows as marketed.
3 holders have a Canadian DIN containing Fosfomycin, across 6 DINs, of which 3 are currently marketed. Marketed count is the number that matters: an approval that is not marketed cannot be bought.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| VERITY PHARMACEUTICALS INC. | 3 | 1 | IVOZFO | Sourceable in Canada |
| ENDO OPERATIONS LTD. | 2 | 1 | FOSFOMYCIN POWDER FOR ORAL SOLUTION, MONUROL | Sourceable in Canada |
| JAMP PHARMA CORPORATION | 1 | 1 | JAMP-FOSFOMYCIN | Sourceable in Canada |
Health Canada’s Drug Product Database does not flag which listing is the originator and which are subsequent-entry products, so Nexara does not label them here. Interchangeability is determined provincially, not federally — confirm for your province before a formulary switch. Nexara can confirm which of these is actually obtainable, and on what lead time, per order.
How is it supplied and stored?
Pack configuration, storage class and the handling constraints that drive cold-chain planning. One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced.
| Strength on the label | 3 G |
|---|---|
| Dosage form | POWDER FOR SOLUTION |
| Route | ORAL |
| Pack configuration (monograph) | Available as a single-dose sachet. |
| Storage | Not explicitly specified in provided text (Section 11 header present but content missing). Typically 15-30°C for this form. |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Fosfomycin |
|---|---|
| ATC code | J01XX01 |
| AHFS class | 08:36.00 |
| Biosimilar biologic | No |
Health Canada record and identifiers
The regulatory facts straight from the Drug Product Database, plus every identifier form Nexara accepts on a purchase order. A DIN written without its leading zeros is the commonest reason an order line fails to match.
| DIN (8-digit, as used in ordering) | 02240335 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2240335 |
| Brand name | MONUROL |
| Generic / active ingredient | FOSFOMYCIN (FOSFOMYCIN TROMETHAMINE) : 3 G |
| Market authorization holder | ENDO OPERATIONS LTD. |
| Health Canada schedule | Prescription |
| ATC code | J01XX01 |
| ATC anatomical main group | J — Anti-infectives for systemic use |
| ATC therapeutic subgroup | J01XX |
| Current status | MARKETED |
| Status date | 01-Apr-2026 |
| Original market date | 1999-09-15 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Single 3g dose sachet. Dissolve in 125 mL cold water and take immediately on an empty stomach or 2-3 hours after a meal.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to the drug or any ingredient, including sulphites (found in mandarin and orange flavourings).
Warnings and precautions
Clostridium difficile-associated disease (CDAD); hypersensitivity/anaphylaxis (contains sulphites); dizziness may affect driving; not for persistent/complicated infections.
What can be used instead?
Alternatives on every axis a buyer actually considers — the same molecule in another presentation, the same class, an adjacent class, or a fixed-dose combination. Every row is led by the marketed DIN count, because that is what can be bought this week.
1 · Same molecule, other Canadian presentations
3 of 6 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| IVOZFO | 4 G | POWDER FOR SOLUTION | VERITY PHARMACEUTICALS INC. | MARKETED | 02488086 |
| JAMP-FOSFOMYCIN | 3 G | POWDER FOR SOLUTION | JAMP PHARMA CORPORATION | MARKETED | 02473801 |
| FOSFOMYCIN POWDER FOR ORAL SOLUTION | 3 G | POWDER FOR SOLUTION | ENDO OPERATIONS LTD. | CANCELLED PRE MARKET | 02489457 |
| IVOZFO | 2 G | POWDER FOR SOLUTION | VERITY PHARMACEUTICALS INC. | APPROVED | 02488078 |
| IVOZFO | 8 G | POWDER FOR SOLUTION | VERITY PHARMACEUTICALS INC. | APPROVED | 02488094 |
2 · Same class — other molecules in ATC J01XX
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Linezolid | APO-LINEZOLID · JAMP LINEZOLID · LINEZOLID · LINEZOLID INJECTION · +6 more | 19 | 8 | Yes |
| Daptomycin | CUBICIN · CUBICIN RF · DAPTOMYCIN FOR INJECTION · DAPTOMYCIN FOR INJECTION RF | 13 | 3 | Yes |
| Fosfomycin | FOSFOMYCIN POWDER FOR ORAL SOLUTION · IVOZFO · JAMP-FOSFOMYCIN · MONUROL | 6 | 3 | Yes |
| Bacitracin | BACIJECT · BACITRACIN FOR INJECTION · BACITRACIN FOR INJECTION, USP · BACITRACIN USP | 5 | 1 | Yes |
| Lefamulin | XENLETA | 2 | 0 | Not in Canada |
| Methenamine | HIP REX TAB 1GM · MANDELAMINE | 2 | 0 | Not in Canada |
| Methenamine, Combinations | SAPROLEX TAB · URASAL GRANULES | 2 | 0 | Not in Canada |
| Tedizolid | SIVEXTRO | 2 | 0 | Not in Canada |
| Spectinomycin | TROBICIN INJ 400MG/ML | 1 | 0 | Not in Canada |
A molecule with zero marketed DINs cannot be sourced domestically, however many approvals it holds — if one of these sits on a formulary or in an older protocol, that is the line to check.
3 · Adjacent classes in ATC J01X
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| J01XA | Dalbavancin · Telavancin · Vancomycin | 62 | 23 |
| J01XE | Nitrofurantoin | 24 | 9 |
| J01XB | Colistin · Polymyxin B | 6 | 4 |
| J01XD | Metronidazole | 7 | 2 |
| J01XC | Fusidic Acid | 3 | 0 |
Not clinical advice. These tables describe what can be supplied in Canada, not what should be prescribed. Substitution within or across classes is a prescriber and pharmacist decision, and interchangeability is determined provincially.
What else is MONUROL called?
The same molecule, Fosfomycin, is registered under other names elsewhere. Buyers and prescribers searching from outside Canada — or working from a foreign prescription or tender document — often know it by one of these:
| Name | Script | Registered in |
|---|---|---|
| Fomicyt | Latin | Saudi Arabia |
| Actizone | Latin | South Africa |
| Fomnos | Latin | South Africa |
| FORURI | Latin | South Africa |
| Fosfomycin | Latin | Iceland |
| Tractinfect | Latin | South Africa |
| UNAIRA | Latin | Bahrain |
| Urinal | Latin | Saudi Arabia |
| UTICIDE | Latin | South Africa |
| Utimicyn | Latin | South Africa |
Names are taken from national medicine registers and published price lists. A product registered abroad is not authorized for sale in Canada unless it holds its own DIN; import is possible only through the routes Health Canada permits.
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address. Patients and unlicensed buyers are routed to a partner pharmacy.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Why is there no price on this page?
Nexara quotes a delivered Canadian price per order, against a verified licence. Foreign list prices are published on incompatible bases and are not a guide to what any buyer can obtain here, so this page shows which markets list the molecule and on what basis, and nothing more.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.