GEMCITABINE FOR INJECTION 1 G — DIN 02412098
GEMCITABINE (GEMCITABINE HYDROCHLORIDE) : 1 G · FRESENIUS KABI CANADA LTD · POWDER FOR SOLUTION · wholesale supply in Canada
Health Canada status: APPROVED
What is GEMCITABINE FOR INJECTION?
GEMCITABINE FOR INJECTION 1 G contains GEMCITABINE (GEMCITABINE HYDROCHLORIDE) : 1 G. It is listed in the Health Canada Drug Product Database under DIN 02412098, held by FRESENIUS KABI CANADA LTD, supplied as POWDER FOR SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as approved, status dated 19-May-2015. 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 GEMCITABINE FOR INJECTION used for?
Treatment of adenocarcinoma of the pancreas, non-small cell lung cancer (NSCLC), transitional cell carcinoma of the bladder, and breast cancer (in combination with paclitaxel).
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Gemcitabine cost around the world?
Gemcitabine 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); Morocco publishes a PPV (public price). 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 |
|---|---|---|---|---|
| Saudi Arabia | public | 16 | 19 | SAR███.██ |
| United Kingdom | hospital | 14 | 14 | GBP███.██ |
| Greece | producer price (ex-factory) | 13 | 13 | EUR███.██ |
| Morocco | PPV (public price) | 6 | 8 | MAD███.██ |
| South Africa | single exit price | 8 | 8 | ZAR███.██ |
| Australia | ex-manufacturer | 3 | 6 | AUD███.██ |
68 pack listings across 60 brand entries and 6 price bases, refreshed 08 Sep 2026. Ranges span every Gemcitabine 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 Gemcitabine 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.
16 holders have a Canadian DIN containing Gemcitabine, across 38 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 |
|---|---|---|---|---|
| SANDOZ CANADA INCORPORATED | 3 | 1 | GEMCITABINE HYDROCHLORIDE FOR INJECTION, GEMCITABINE INJECTION | Sourceable in Canada |
| PFIZER CANADA ULC | 1 | 1 | GEMCITABINE INJECTION | Sourceable in Canada |
| ACCORD HEALTHCARE INC | 4 | 0 | GEMCITABINE FOR INJECTION, GEMCITABINE FOR INJECTION CONCENTRATE | No marketed DIN |
| ACTAVIS PHARMA COMPANY | 3 | 0 | ACT GEMCITABINE | No marketed DIN |
| AGILA JAMP CANADA INC | 3 | 0 | AJ-GEMCITABINE | No marketed DIN |
| DR REDDY'S LABORATORIES LTD | 3 | 0 | GEMCITABINE FOR INJECTION, USP | No marketed DIN |
| FRESENIUS KABI CANADA LTD | 3 | 0 | GEMCITABINE FOR INJECTION | No marketed DIN |
| HOSPIRA HEALTHCARE ULC | 3 | 0 | GEMCITABINE FOR INJECTION, USP | No marketed DIN |
| MYLAN PHARMACEUTICALS ULC | 3 | 0 | GEMCITABINE FOR INJECTION, USP | No marketed DIN |
| ELI LILLY CANADA INC | 2 | 0 | GEMZAR (1GM/VIAL), GEMZAR (200MG/VIAL) | No marketed DIN |
| GENERIC MEDICAL PARTNERS INC | 2 | 0 | GEMCITABINE FOR INJECTION USP | No marketed DIN |
| TELIP, LLC, A SUBSIDIARY OF TELIGENT, INC. | 2 | 0 | GEMCITABINE FOR INJECTION | 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 | 1 G |
|---|---|
| Dosage form | POWDER FOR SOLUTION |
| Route | INTRAVENOUS |
| Pack configuration (monograph) | 200 mg, 1 g and 2 g gemcitabine (as gemcitabine hydrochloride) per vial. |
| Storage | Not explicitly detailed in provided text snippet (refer to STORAGE AND STABILITY section 27). |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Gemcitabine |
|---|---|
| ATC code | L01BC05 |
| 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) | 02412098 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2412098 |
| Brand name | GEMCITABINE FOR INJECTION |
| Generic / active ingredient | GEMCITABINE (GEMCITABINE HYDROCHLORIDE) : 1 G |
| Market authorization holder | FRESENIUS KABI CANADA LTD |
| Health Canada schedule | Prescription |
| ATC code | L01BC05 |
| ATC anatomical main group | L — Antineoplastic and immunomodulating agents |
| ATC therapeutic subgroup | L01BC |
| Current status | APPROVED |
| Status date | 19-May-2015 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Intravenous administration only. Prolongation of infusion >60 min or more frequent than weekly dosing increases toxicity. Monitor blood counts prior to each dose; reduce or omit based on toxicity.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to this drug or to any ingredient in the formulation or component of the container.
Warnings and precautions
Cytotoxic agent. Can cause severe bone marrow suppression, pulmonary toxicity (ARDS, edema), hemolytic uremic syndrome (HUS), capillary leak syndrome (CLS), and serious hepatotoxicity.
Is Gemcitabine in shortage in Canada?
A Canadian shortage report is on file for a product containing this molecule: Anticipated — reported by PFIZER CANADA ULC, last seen 09 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
2 of 38 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| GEMCITABINE INJECTION | 38 MG | SOLUTION | PFIZER CANADA ULC | MARKETED | 02402831 |
| GEMCITABINE INJECTION | 40 MG | SOLUTION | SANDOZ CANADA INCORPORATED | MARKETED | 02412292 |
| ACT GEMCITABINE | 38 MG | SOLUTION | ACTAVIS PHARMA COMPANY | CANCELLED POST MARKET | 02433117 |
| ACT GEMCITABINE | 200 MG | POWDER FOR SOLUTION | ACTAVIS PHARMA COMPANY | CANCELLED PRE MARKET | 02436191 |
| ACT GEMCITABINE | 1 G | POWDER FOR SOLUTION | ACTAVIS PHARMA COMPANY | CANCELLED PRE MARKET | 02436205 |
| AJ-GEMCITABINE | 200 MG | POWDER FOR SOLUTION | AGILA JAMP CANADA INC | CANCELLED PRE MARKET | 02409054 |
| AJ-GEMCITABINE | 2 G | POWDER FOR SOLUTION | AGILA JAMP CANADA INC | CANCELLED PRE MARKET | 02409070 |
| AJ-GEMCITABINE | 1 G | POWDER FOR SOLUTION | AGILA JAMP CANADA INC | CANCELLED PRE MARKET | 02409062 |
| GEMCITABINE FOR INJECTION | 200 MG | POWDER FOR SOLUTION | TEVA CANADA LIMITED | CANCELLED POST MARKET | 02305526 |
| GEMCITABINE FOR INJECTION | 200 MG | POWDER FOR SOLUTION | ACCORD HEALTHCARE INC | CANCELLED POST MARKET | 02324202 |
2 · Same class — other molecules in ATC L01BC
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Capecitabine | ACH-CAPECITABINE · APO-CAPECITABINE · CAPECITABINE · MINT-CAPECITABINE · +4 more | 20 | 11 | Yes |
| Azacitidine | AZACITIDINE FOR INJECTION · NAT-AZACITIDINE · ONUREG · PMS-AZACITIDINE FOR INJECTION · +2 more | 14 | 7 | Yes |
| Fluorouracil | ADRUCIL · ADRUCIL INJ 50MG/ML · EFUDEX · FLUOROPLEX CREAM 1% · +4 more | 15 | 6 | Yes |
| Cytarabine | AJ-CYTARABINE · CYTARABINE - PWS 1GN/VIAL · CYTARABINE - PWS 2GM/VIAL · CYTARABINE - PWS 500MG/VIAL · +8 more | 19 | 3 | Yes |
| Gemcitabine | ACT GEMCITABINE · AJ-GEMCITABINE · GEMCITABINE FOR INJECTION · GEMCITABINE FOR INJECTION CONCENTRATE · +7 more | 38 | 2 | Yes |
| Trifluridine, Combinations | LONSURF | 2 | 2 | Yes |
| Decitabine | DACOGEN · DEMYLOCAN | 2 | 1 | Yes |
| Fluorouracil, Combinations | ACTIKERALL | 1 | 1 | Yes |
| Decitabine, Combinations | INQOVI | 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 |
| L01BB | Cladribine · Clofarabine · Fludarabine · Mercaptopurine · Nelarabine · +1 more | 18 | 10 |
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 GEMCITABINE FOR INJECTION called?
The same molecule, Gemcitabine, 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 |
|---|---|---|
| DBL Gemcitabine Injection | Latin | Australia |
| GEBTIN | Latin | Saudi Arabia |
| GEMCITABINE EUGIA | Latin | Australia |
| Gemcitabine Irem | Latin | Australia |
| GEMZAR | Latin | Morocco |
| ONGECIN | Latin | Morocco |
| Gemcitabine BOS | Latin | Saudi Arabia |
| Gemcitabine Neapolis | Latin | Saudi Arabia |
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.
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.