PROTAMINE SULFATE INJECTION, USP 10 MG — DIN 02139537
PROTAMINE SULFATE : 10 MG · FRESENIUS KABI CANADA LTD · SOLUTION · wholesale supply in Canada
Health Canada status: MARKETED
What is PROTAMINE SULFATE INJECTION, USP?
PROTAMINE SULFATE INJECTION, USP 10 MG contains PROTAMINE SULFATE : 10 MG. It is listed in the Health Canada Drug Product Database under DIN 02139537, held by FRESENIUS KABI CANADA LTD, supplied as SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 19-May-2016. 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.
How much does Protamine cost around the world?
Protamine is listed on 3 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. Greece publishes a producer price (ex-factory); Morocco publishes a PPV (public price); United Kingdom publishes a hospital. 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 Kingdom | hospital | 1 | 1 | GBP███.██ |
| Greece | producer price (ex-factory) | 1 | 1 | EUR███.██ |
| Morocco | PPV (public price) | 1 | 1 | MAD███.██ |
3 pack listings across 3 brand entries and 3 price bases, refreshed 05 Sep 2026. Ranges span every Protamine 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 Protamine 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.
4 holders have a Canadian DIN containing Protamine, across 4 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 |
|---|---|---|---|---|
| FRESENIUS KABI CANADA LTD | 1 | 1 | PROTAMINE SULFATE INJECTION, USP | Sourceable in Canada |
| SANDOZ CANADA INCORPORATED | 1 | 1 | PROTAMINE SULFATE INJECTION USP | Sourceable in Canada |
| LYPHOMED, DIVISION OF FUJISAWA CANADA INC. | 1 | 0 | PROTAMINE SULFATE INJ 10MG/ML USP | No marketed DIN |
| OMEGA LABORATORIES LIMITED | 1 | 0 | PROTAMINE SULFATE 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 | 10 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 | Protamine |
|---|---|
| ATC code | V03AB14 |
| AHFS class | 40:12.00 |
| 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) | 02139537 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2139537 |
| Brand name | PROTAMINE SULFATE INJECTION, USP |
| Generic / active ingredient | PROTAMINE SULFATE : 10 MG |
| Market authorization holder | FRESENIUS KABI CANADA LTD |
| Health Canada schedule | Ethical |
| ATC code | V03AB14 |
| ATC anatomical main group | V — Various |
| ATC therapeutic subgroup | V03AB |
| Current status | MARKETED |
| Status date | 19-May-2016 |
| Original market date | 1996-08-14 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
Is Protamine in shortage in Canada?
A Canadian shortage report is on file for a product containing this molecule: Resolved — reported by SANDOZ CANADA INCORPORATED, last seen 21 Aug 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 4 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| PROTAMINE SULFATE INJECTION USP | 10 MG | SOLUTION | SANDOZ CANADA INCORPORATED | MARKETED | 02231674 |
| PROTAMINE SULFATE INJ 10MG/ML USP | 10 MG | LIQUID | LYPHOMED, DIVISION OF FUJISAWA CANADA INC. | CANCELLED POST MARKET | 01944851 |
| PROTAMINE SULFATE INJECTION USP | 10 MG | LIQUID | OMEGA LABORATORIES LIMITED | CANCELLED POST MARKET | 02240618 |
2 · Same class — other molecules in ATC V03AB
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Naloxone | INJECTABLE NALOXONE HYDROCHLORIDE · KLOXXADO · NALOXONE HCL INJECTION - 0.4MG/ML USP · NALOXONE HCL INJECTION - 1MG/ML USP · +11 more | 26 | 12 | Yes |
| Sugammadex | BRIDION · PMS-SUGAMMADEX · SUGAMMADEX · SUGAMMADEX INJECTION · +1 more | 14 | 4 | Yes |
| Thiosulphate | SEACALPHYX · SODIUM THIOSULFATE INJ 25% USP · SODIUM THIOSULFATE INJECTION USP | 4 | 3 | Yes |
| Methylthioninium Chloride | METHYLENE BLEU LIQ 2% · METHYLENE BLUE INJ 1% · METHYLENE BLUE INJ 1% USP · METHYLENE BLUE INJ 10MG/ML USP · +3 more | 11 | 2 | Yes |
| Flumazenil | ANEXATE INJ 0.1MG/ML · FLUMAZENIL INJECTION · FLUMAZENIL INJECTION SDZ · FLUMAZENIL INJECTION, USP · +1 more | 6 | 2 | Yes |
| Protamine | PROTAMINE SULFATE INJ 10MG/ML USP · PROTAMINE SULFATE INJECTION USP · PROTAMINE SULFATE INJECTION, USP | 4 | 2 | Yes |
| Fomepizole | ANTIZOL · FOMEPIZOLE FOR INJECTION | 2 | 2 | Yes |
| Hydroxocobalamin | CYANOKIT | 2 | 1 | Yes |
| Digitalis Antitoxin | DIGIBIND · DIGIFAB | 2 | 1 | Yes |
| Idarucizimab | PRAXBIND | 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 V03A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| V03AC | Deferasirox · Deferiprone · Deferoxamine | 57 | 44 |
| V03AN | Carbon Dioxide · Combination · Helium · Medical Air · Medical Gases · +2 more | 112 | 43 |
| V03AE | Calcium Acetate · Drugs For Treatment Of Hyperkalemia And Hyperphosphatemia · Lanthanum Carbonate · Patiromer Calcium · Polystyrene Sulphonate · +3 more | 40 | 19 |
| V03AF | Amifostine · Calcium Folinate · Dexrazoxane · Mesna · Palifermin · +1 more | 34 | 16 |
| V03AH | Diazoxide | 2 | 1 |
| V03AX | Cobicistat · Difelikefalin · Other Therapeutic Products | 8 | 1 |
| V03AZ | Ethanol | 1 | 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 PROTAMINE SULFATE INJECTION, USP called?
Also recorded in Canada as: 5 ML protamine sulfate (USP) 10 MG/ML Injection (US), 25 ML protamine sulfate (USP) 10 MG/ML Injection (US), PROTAMINE SULFATE (US), Protamine Sulfate Injection (US), Protamine Sulfate LEO (UK), Protamine Sulfate Injection (JP), Protamine Sulfate Injection (IN), Protamine Sulfate (GLOBAL), Protamine Sulphate (UK).
The same molecule, Protamine, 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 |
|---|---|---|
| PROTAMINE CHOAY | Latin | Morocco |
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.