AMPHOTERICIN B FOR INJECTION, USP 50 MG — DIN 02405032
AMPHOTERICIN B : 50 MG · STERIMAX INC · POWDER FOR SOLUTION · wholesale supply in Canada
Health Canada status: APPROVED
What is AMPHOTERICIN B FOR INJECTION, USP?
AMPHOTERICIN B FOR INJECTION, USP 50 MG contains AMPHOTERICIN B : 50 MG. It is listed in the Health Canada Drug Product Database under DIN 02405032, held by STERIMAX INC, supplied as POWDER FOR SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as approved, status dated 22-Apr-2013. 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.
Is there a generic Amphotericin B 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.
6 holders have a Canadian DIN containing Amphotericin B, across 7 DINs, of which 2 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 |
|---|---|---|---|---|
| ASTELLAS PHARMA CANADA INC | 1 | 1 | AMBISOME | Sourceable in Canada |
| CHEPLAPHARM ARZNEIMITTEL GMBH | 1 | 1 | FUNGIZONE | Sourceable in Canada |
| THREE RIVERS PHARMACEUTICALS LLC | 2 | 0 | AMPHOTEC 100 MG, AMPHOTEC 50 MG | No marketed DIN |
| LEADIANT BIOSCIENCES, INC | 1 | 0 | ABELCET | No marketed DIN |
| STERIMAX INC | 1 | 0 | AMPHOTERICIN B FOR INJECTION, USP | No marketed DIN |
| TARO PHARMACEUTICALS INC | 1 | 0 | TARO-AMPHOTERICIN B LIPOSOMAL | 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 | 50 MG |
|---|---|
| Dosage form | POWDER FOR SOLUTION |
| Route | INTRAVENOUS |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Amphotericin B |
|---|---|
| ATC code | J02AA01 |
| AHFS class | 08:14.28 |
| 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) | 02405032 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2405032 |
| Brand name | AMPHOTERICIN B FOR INJECTION, USP |
| Generic / active ingredient | AMPHOTERICIN B : 50 MG |
| Market authorization holder | STERIMAX INC |
| Health Canada schedule | Prescription |
| ATC code | J02AA01 |
| ATC anatomical main group | J — Anti-infectives for systemic use |
| ATC therapeutic subgroup | J02AA |
| Current status | APPROVED |
| Status date | 22-Apr-2013 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
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
2 of 7 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| AMBISOME | 50 MG | POWDER FOR SOLUTION | ASTELLAS PHARMA CANADA INC | MARKETED | 02241630 |
| FUNGIZONE | 50 MG | POWDER FOR SOLUTION | CHEPLAPHARM ARZNEIMITTEL GMBH | MARKETED | 00029149 |
| ABELCET | 5 MG | SUSPENSION | LEADIANT BIOSCIENCES, INC | CANCELLED POST MARKET | 02231590 |
| AMPHOTEC 100 MG | 100 MG | POWDER FOR SUSPENSION | THREE RIVERS PHARMACEUTICALS LLC | CANCELLED POST MARKET | 02241749 |
| AMPHOTEC 50 MG | 50 MG | POWDER FOR SUSPENSION | THREE RIVERS PHARMACEUTICALS LLC | CANCELLED POST MARKET | 02241750 |
| TARO-AMPHOTERICIN B LIPOSOMAL | 50 MG | POWDER FOR SOLUTION | TARO PHARMACEUTICALS INC | APPROVED | 02554186 |
2 · Same class — other molecules in ATC J02AA
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Amphotericin B | ABELCET · AMBISOME · AMPHOTEC 100 MG · AMPHOTEC 50 MG · +3 more | 7 | 2 | Yes |
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 J02A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| J02AC | Fluconazole · Isavuconazole · Itraconazole · Posaconazole · Voriconazole | 115 | 54 |
| J02AX | Anidulafungin · Caspofungin · Micafungin | 25 | 12 |
| J02AB | Ketoconazole | 5 | 2 |
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.
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.
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.