TOBRAMYCIN INHALATION SOLUTION USP 300 MG / 5 ML — DIN 02457563
TOBRAMYCIN (TOBRAMYCIN SULFATE) : 300 MG / 5 ML · LABORATOIRE RIVA INC. · SOLUTION · wholesale supply in Canada
Health Canada status: APPROVED
What is TOBRAMYCIN INHALATION SOLUTION USP?
TOBRAMYCIN INHALATION SOLUTION USP 300 MG / 5 ML contains TOBRAMYCIN (TOBRAMYCIN SULFATE) : 300 MG / 5 ML. It is listed in the Health Canada Drug Product Database under DIN 02457563, held by LABORATOIRE RIVA INC., supplied as SOLUTION for INHALATION administration. Health Canada currently lists it as approved, status dated 19-Sep-2017. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A). This DIN is not currently being marketed in Canada, so it is sourced to order where a compliant route exists rather than held in stock.
What is TOBRAMYCIN INHALATION SOLUTION USP used for?
Management of cystic fibrosis patients (6 years and older) with chronic pulmonary Pseudomonas aeruginosa infections.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Tobramycin cost around the world?
Tobramycin is listed on 14 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. Australia publishes a ex-manufacturer; Austria publishes a KVP (Kassenverkaufspreis); Bahrain publishes a retail (max). 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 | 3 | 19 | USD███.██ |
| Saudi Arabia | public | 13 | 13 | SAR███.██ |
| Australia | ex-manufacturer | 7 | 12 | AUD███.██ |
| Bahrain | retail (max) | 9 | 10 | BHD███.██ |
| South Africa | single exit price | 9 | 10 | ZAR███.██ |
| Romania | max producer price | 6 | 9 | RON███.██ |
| Greece | producer price (ex-factory) | 8 | 8 | EUR███.██ |
| Norway | max AUP (pharmacy retail) | 7 | 7 | NOK███.██ |
| Sweden | AIP (pharmacy purchase price) | 5 | 7 | SEK███.██ |
| United Kingdom | hospital | 5 | 5 | GBP███.██ |
| United Arab Emirates | public | 4 | 4 | AED███.██ |
| Luxembourg | reimbursement | 4 | 4 | EUR███.██ |
| Austria | KVP (Kassenverkaufspreis) | 2 | 2 | EUR███.██ |
| Czechia | max producer price (ex-factory) | 2 | 2 | CZK███.██ |
112 pack listings across 84 brand entries and 13 price bases, refreshed 08 Sep 2026. Ranges span every Tobramycin 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 Tobramycin 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.
10 holders have a Canadian DIN containing Tobramycin, across 23 DINs, of which 9 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 |
|---|---|---|---|---|
| FRESENIUS KABI CANADA LTD | 3 | 2 | TOBRAMYCIN FOR INJECTION, TOBRAMYCIN INJECTION | Sourceable in Canada |
| SANDOZ CANADA INCORPORATED | 3 | 2 | TOBRAMYCIN INHALATION SOLUTION, TOBRAMYCIN INJECTION USP | Sourceable in Canada |
| BGP PHARMA ULC | 2 | 2 | TOBI, TOBI PODHALER | Sourceable in Canada |
| STERIMAX INC | 3 | 1 | TOBRAMYCIN FOR INJECTION USP, TOBRAMYCIN INJECTION USP | Sourceable in Canada |
| JAMP PHARMA CORPORATION | 2 | 1 | JAMP-TOBRAMYCIN, TOBRAMYCIN INJECTION USP | Sourceable in Canada |
| TEVA CANADA LIMITED | 1 | 1 | TEVA-TOBRAMYCIN | Sourceable in Canada |
| ELI LILLY CANADA INC | 6 | 0 | NEBCIN INJ 1.2GM/30ML, NEBCIN INJ 10MG/ML, NEBCIN INJ 10MG/ML (VANTAGE VIAL), NEBCIN INJ 40MG/ML, NEBCIN INJ 60MG, +1 more | No marketed DIN |
| AGILA JAMP CANADA INC | 1 | 0 | AJ-TOBRAMYCIN | No marketed DIN |
| LABORATOIRE RIVA INC. | 1 | 0 | TOBRAMYCIN INHALATION SOLUTION USP | No marketed DIN |
| MYLAN PHARMACEUTICALS ULC | 1 | 0 | TOBRAMYCIN INJECTION, USP | No marketed DIN |
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 | 300 MG / 5 ML |
|---|---|
| Dosage form | SOLUTION |
| Route | INHALATION |
| Pack configuration (monograph) | Boxes of 56 single-use 5 mL ampoules (14 foil over-pouches containing 4 ampoules each). |
| Storage | Not explicitly detailed in provided text snippet (standard USP storage usually applies, but text cuts off before section 11 details). |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation, because this listing covers more than one of them.
Substance and classification
| Active substance | Tobramycin |
|---|---|
| ATC code | J01GB01 |
| 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) | 02457563 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2457563 |
| Brand name | TOBRAMYCIN INHALATION SOLUTION USP |
| Generic / active ingredient | TOBRAMYCIN (TOBRAMYCIN SULFATE) : 300 MG / 5 ML |
| Market authorization holder | LABORATOIRE RIVA INC. |
| Health Canada schedule | Prescription |
| ATC code | J01GB01 |
| ATC anatomical main group | J — Anti-infectives for systemic use |
| ATC therapeutic subgroup | J01GB |
| Current status | APPROVED |
| Status date | 19-Sep-2017 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
300 mg (one ampoule) via nebulizer twice daily for 28 days, followed by 28 days off. Doses should be ~12 hours apart (min 6 hours). Not for SC, IV, or intrathecal use.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Known hypersensitivity to any aminoglycoside or to any ingredient in the formulation.
Warnings and precautions
Risk of ototoxicity (hearing/vestibular), nephrotoxicity, and neuromuscular blockade. Bronchospasm may occur. Risk of ototoxicity may be increased in patients with certain mitochondrial DNA variants.
Is Tobramycin in shortage in Canada?
A Canadian shortage report is on file for a product containing this molecule: Resolved — reported by FRESENIUS KABI CANADA LTD, last seen 04 Sep 2026. A shortage on one presentation does not always affect every DIN of the molecule — the alternatives below list what else is marketed in Canada. Nexara can confirm current availability and identify substitutions or import options where permitted.
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
9 of 23 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| TEVA-TOBRAMYCIN | 60 MG | SOLUTION | TEVA CANADA LIMITED | MARKETED | 02389622 |
| TOBI | 300 MG / 5 ML | SOLUTION | BGP PHARMA ULC | MARKETED | 02239630 |
| TOBI PODHALER | 28 MG | CAPSULE | BGP PHARMA ULC | MARKETED | 02365154 |
| TOBRAMYCIN FOR INJECTION | 1.2 G | POWDER FOR SOLUTION | FRESENIUS KABI CANADA LTD | MARKETED | 00533688 |
| TOBRAMYCIN INJECTION | 40 MG | SOLUTION | FRESENIUS KABI CANADA LTD | MARKETED | 02230640 |
| TOBRAMYCIN INJECTION USP | 40 MG | SOLUTION | STERIMAX INC | MARKETED | 02502372 |
| TOBRAMYCIN INJECTION USP | 40 MG | SOLUTION | JAMP PHARMA CORPORATION | MARKETED | 02533103 |
| TOBRAMYCIN INJECTION USP | 10 MG | SOLUTION | SANDOZ CANADA INCORPORATED | MARKETED | 02241209 |
| TOBRAMYCIN INJECTION USP | 40 MG | SOLUTION | SANDOZ CANADA INCORPORATED | MARKETED | 02241210 |
| AJ-TOBRAMYCIN | 40 MG | LIQUID | AGILA JAMP CANADA INC | CANCELLED PRE MARKET | 02384930 |
2 · Same class — other molecules in ATC J01GB
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Tobramycin | AJ-TOBRAMYCIN · JAMP-TOBRAMYCIN · NEBCIN INJ 1.2GM/30ML · NEBCIN INJ 10MG/ML · +14 more | 23 | 9 | Yes |
| Gentamicin | CIDOMYCIN INJ 10MG/ML · CIDOMYCIN INJ 40MG/ML · CIDOMYCIN INJ PEDIATRIC 10MG · GARAMYCIN INJ 10MG/ML PEDIATRIC · +10 more | 20 | 6 | Yes |
| Amikacin | AMIKACIN SULFATE INJECTION · AMIKACIN SULFATE INJECTION USP · AMIKIN · ERFA-AMIKACIN · +1 more | 9 | 4 | Yes |
| Neomycin | MYCIFRADIN SULFATE ORAL SOLUTION · MYCIFRADIN SULFATE TABLETS 0.5 GM | 2 | 0 | Not in Canada |
| Netilmicin | NETROMYCIN INJ 100MG/ML · NETROMYCIN INJ 50MG/ML | 2 | 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 J01G
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| J01GA | Streptomycin | 2 | 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 TOBRAMYCIN INHALATION SOLUTION USP called?
The same molecule, Tobramycin, 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 |
|---|---|---|
| Tobi | Latin | Australia, Bahrain, Norway, Sweden |
| Tobi podhaler | Latin | Australia, Czechia, Norway |
| Bramitob | Latin | Bahrain, Czechia, Norway, Sweden |
| Micro-Tobramicin | Latin | South Africa |
| TOBRACIN | Latin | Bahrain |
| TOBRAMYCIN SUN | Latin | Australia |
| TOBRAMYCIN WKT | Latin | Australia |
| Tobrasone | Latin | Norway, Sweden |
| Tofibra | Latin | Bahrain, Saudi Arabia |
| Toflacort | Latin | Norway, Sweden |
| MYDEX | Latin | South Africa |
| Nebcin | Latin | South Africa |
| OPTIDEX T | Latin | Bahrain |
| OPTIDEX-T STERILE OPHTALMIC SUSP | Latin | Saudi Arabia |
| Pfizer Australia Pty Ltd | Latin | Australia |
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?
This product is approved by Health Canada but not yet marketed in Canada, so there is no Canadian supply to draw on today. Nexara can tell you whether it has been launched, and can look at supply from other markets where a Canadian pack is not required or where importation is permitted.
Ask about availability of TOBRAMYCIN INHALATION SOLUTION USP
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.