FLUDARABINE PHOSPHATE INJECTION 25 MG — DIN 02406381
FLUDARABINE PHOSPHATE : 25 MG · MYLAN PHARMACEUTICALS ULC · SOLUTION · wholesale supply in Canada
Health Canada status: CANCELLED PRE MARKET
What is FLUDARABINE PHOSPHATE INJECTION?
FLUDARABINE PHOSPHATE INJECTION 25 MG contains FLUDARABINE PHOSPHATE : 25 MG. It is listed in the Health Canada Drug Product Database under DIN 02406381, held by MYLAN PHARMACEUTICALS ULC, supplied as SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as cancelled pre market, status dated 28-Feb-2022. This Drug Identification Number is no longer authorized for sale in Canada, so Nexara does not supply it. The record is kept here because buyers still meet the number on old formularies, purchase orders and tender documents; Nexara can help identify an authorized alternative.
How much does Fludarabine cost around the world?
Fludarabine is listed on 6 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; Greece publishes a producer price (ex-factory); Hungary publishes a producer price (ex-factory). 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 |
|---|---|---|---|---|
| Australia | ex-manufacturer | 3 | 5 | AUD███.██ |
| Morocco | PPV (public price) | 1 | 4 | MAD███.██ |
| Greece | producer price (ex-factory) | 2 | 2 | EUR███.██ |
| Hungary | producer price (ex-factory) | 2 | 2 | HUF███.██ |
| United Kingdom | hospital | 1 | 1 | GBP███.██ |
| South Africa | single exit price | 1 | 1 | ZAR███.██ |
15 pack listings across 10 brand entries and 5 price bases, refreshed 08 Sep 2026. Ranges span every Fludarabine 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 Fludarabine 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.
9 holders have a Canadian DIN containing Fludarabine, across 10 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 |
|---|---|---|---|---|
| ACCORD HEALTHCARE INC | 1 | 1 | FLUDARABINE PHOSPHATE INJECTION, USP | Sourceable in Canada |
| SANOFI-AVENTIS CANADA INC | 1 | 1 | FLUDARA | Sourceable in Canada |
| TEVA CANADA LIMITED | 1 | 1 | FLUDARABINE PHOSPHATE FOR INJECTION | Sourceable in Canada |
| FRESENIUS KABI CANADA LTD | 2 | 0 | FLUDARABINE PHOSPHATE FOR INJECTION, FLUDARABINE PHOSPHATE INJECTION | No marketed DIN |
| AGILA JAMP CANADA INC | 1 | 0 | AJ-FLUDARABINE | No marketed DIN |
| HOSPIRA HEALTHCARE ULC | 1 | 0 | FLUDARABINE PHOSPHATE FOR INJECTION USP | No marketed DIN |
| MYLAN PHARMACEUTICALS ULC | 1 | 0 | FLUDARABINE PHOSPHATE INJECTION | No marketed DIN |
| OMEGA LABORATORIES LIMITED | 1 | 0 | FLUDARABINE PHOSPHATE INJECTION | No marketed DIN |
| SANOFI GENZYME, A DIVISION OF SANOFI-AVENTIS CANADA INC | 1 | 0 | FLUDARA | 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 | 25 MG |
|---|---|
| Dosage form | SOLUTION |
| Route | INTRAVENOUS |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Fludarabine |
|---|---|
| ATC code | L01BB05 |
| AHFS class | 10:00.00 |
| 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) | 02406381 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2406381 |
| Brand name | FLUDARABINE PHOSPHATE INJECTION |
| Generic / active ingredient | FLUDARABINE PHOSPHATE : 25 MG |
| Market authorization holder | MYLAN PHARMACEUTICALS ULC |
| Health Canada schedule | Prescription |
| ATC code | L01BB05 |
| ATC anatomical main group | L — Antineoplastic and immunomodulating agents |
| ATC therapeutic subgroup | L01BB |
| Current status | CANCELLED PRE MARKET |
| Status date | 28-Feb-2022 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
Is Fludarabine in shortage in Canada?
A Canadian shortage report is on file for a product containing this molecule: Resolved — reported by ACCORD HEALTHCARE INC, 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
3 of 10 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| FLUDARA | 10 MG | TABLET | SANOFI-AVENTIS CANADA INC | MARKETED | 02246226 |
| FLUDARABINE PHOSPHATE FOR INJECTION | 25 MG | SOLUTION | TEVA CANADA LIMITED | MARKETED | 02283859 |
| FLUDARABINE PHOSPHATE INJECTION, USP | 25 MG | SOLUTION | ACCORD HEALTHCARE INC | MARKETED | 02438577 |
| AJ-FLUDARABINE | 25.0 MG | SOLUTION | AGILA JAMP CANADA INC | CANCELLED PRE MARKET | 02409046 |
| FLUDARA | 50 MG | POWDER FOR SOLUTION | SANOFI GENZYME, A DIVISION OF SANOFI-AVENTIS CANADA INC | CANCELLED POST MARKET | 01989537 |
| FLUDARABINE PHOSPHATE FOR INJECTION | 50 MG | POWDER FOR SOLUTION | FRESENIUS KABI CANADA LTD | CANCELLED PRE MARKET | 02351730 |
| FLUDARABINE PHOSPHATE FOR INJECTION USP | 50 MG | POWDER FOR SOLUTION | HOSPIRA HEALTHCARE ULC | CANCELLED POST MARKET | 02293846 |
| FLUDARABINE PHOSPHATE INJECTION | 25 MG | SOLUTION | FRESENIUS KABI CANADA LTD | DORMANT | 02351722 |
| FLUDARABINE PHOSPHATE INJECTION | 25 MG | LIQUID | OMEGA LABORATORIES LIMITED | APPROVED | 02416069 |
2 · Same class — other molecules in ATC L01BB
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Fludarabine | AJ-FLUDARABINE · FLUDARA · FLUDARABINE PHOSPHATE FOR INJECTION · FLUDARABINE PHOSPHATE FOR INJECTION USP · FLUDARABINE PHOSPHATE INJECTION · FLUDARABINE PHOSPHATE INJECTION, USP | 10 | 3 | Yes |
| Cladribine | CLADRIBINE INJECTION · LEUSTATIN 1MG/ML | 3 | 2 | Yes |
| Mercaptopurine | MERCAPTOPURINE TABLETS USP · PURINETHOL | 2 | 2 | Yes |
| Clofarabine | CLOLAR | 1 | 1 | Yes |
| Nelarabine | ATRIANCE | 1 | 1 | Yes |
| Tioguanine | LANVIS | 1 | 1 | 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 L01B
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| L01BA | Methotrexate · Pemetrexed · Pralatrexate% · Raltitrexed | 90 | 36 |
| L01BC | Azacitidine · Capecitabine · Cytarabine · Decitabine · Decitabine, Combinations · Fluorouracil · Fluorouracil, Combinations · Gemcitabine · Trifluridine, Combinations | 112 | 34 |
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 FLUDARABINE PHOSPHATE INJECTION called?
Also recorded in Canada as: fludarabine phosphate 50 MG Injection (US), 2 ML fludarabine phosphate 25 MG/ML Injection (US), fludarabine phosphate 10 MG Oral Tablet (US), FLUDARABINE PHOSPHATE (US).
The same molecule, Fludarabine, 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 |
|---|---|---|
| Fludara | Latin | Australia, Morocco |
| Fludarabine Ebewe | Latin | Australia |
| Fludarabine Juno | 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.
Can this still be bought in Canada?
No. This Drug Identification Number is cancelled pre market in Health Canada's Drug Product Database, so the product is no longer authorized for sale in Canada and Nexara does not supply it. This page is kept as a regulatory record.
If you are looking for a current equivalent, the alternatives above list every product sharing this therapeutic class, with the marketed ones first. Ask us to source an alternative
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.