SYNACTHEN DEPOT 1 MG — DIN 00253952
TETRACOSACTIDE (TETRACOSACTIDE ZINC HYDROXIDE) : 1 MG · ATNAHS PHARMA UK LIMITED · SUSPENSION · wholesale supply in Canada
Health Canada status: DORMANT
What is SYNACTHEN DEPOT?
SYNACTHEN DEPOT 1 MG contains TETRACOSACTIDE (TETRACOSACTIDE ZINC HYDROXIDE) : 1 MG. It is listed in the Health Canada Drug Product Database under DIN 00253952, held by ATNAHS PHARMA UK LIMITED, supplied as SUSPENSION for INTRAMUSCULAR administration. Health Canada currently lists it as dormant, status dated 09-Jul-2021. 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 SYNACTHEN DEPOT used for?
SYNACTHEN DEPOT is intended for use as a diagnostic agent in the screening of patients presumed to have adrenocortical insufficiency. It is also used in the treatment of certain conditions that are responsive to corticoids, including: Collagen Diseases: Acute rheumatic fever; rheumatoid arthritis; lupus erythematosus; periarteritis nodosa, psoriatic arthritis; scleroderma; rheumatoid spondylitis; Still's disease. Dermatologic Diseases: Exfoliative dermatitis; dermatomyositis; pemphigus. Endocrine Diseases: Panhypopituitarism. Eye Diseases: Choroiditis; conjunctivitis; iritis; keratitis; optic neuritis; sympathetic ophthalmia; uveitis. Hemolytic Diseases: Acquired hemolytic jaundice. Other Diseases: Nephrotic syndrome; ulcerative colitis; Bell's palsy; acute exacerbations of multiple sclerosis, and as adjuvant treatment in cases of acute gout.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Tetracosactide cost around the world?
Tetracosactide is listed on 5 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; Iceland publishes a max wholesale; 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 |
|---|---|---|---|---|
| Iceland | max wholesale | 1 | 3 | ISK███.██ |
| Saudi Arabia | public | 1 | 2 | SAR███.██ |
| Australia | ex-manufacturer | 1 | 1 | AUD███.██ |
| Morocco | PPV (public price) | 1 | 1 | MAD███.██ |
| South Africa | single exit price | 1 | 1 | ZAR███.██ |
8 pack listings across 5 brand entries and 5 price bases, refreshed 08 Sep 2026. Ranges span every Tetracosactide 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 Tetracosactide 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.
2 holders have a Canadian DIN containing Tetracosactide, across 2 DINs, of which 1 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 |
|---|---|---|---|---|
| AMPHASTAR PHARMACEUTICALS, INC. | 1 | 1 | CORTROSYN INJ 0.25MG | Sourceable in Canada |
| ATNAHS PHARMA UK LIMITED | 1 | 0 | SYNACTHEN DEPOT | 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 MG |
|---|---|
| Dosage form | SUSPENSION |
| Route | INTRAMUSCULAR |
| Pack configuration (monograph) | SYNACTHEN DEPOT (tetracosactide zinc injection) 1 mg/mL: Each 1 mL ampoule of milky-white suspension for intramuscular injection contains 1 mg tetracosactide as zinc hydroxide complex. Available in cartons of 1 ampoule. |
| Storage | Store in a refrigerator (2 - 8°C); protect from light. Store in the original package or keep the ampoules in the outer carton. Keep out of the sight and reach of children. Do not use after the expiry date shown on the box. |
| Shipping class | Cold chain — validated shipper with temperature monitoring |
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.
Cold chain. This product is stored refrigerated. Nexara ships it on a validated cold chain with temperature monitoring; a delivery address that cannot receive and store it at 2–8 °C on arrival must be flagged before the order is placed.
Substance and classification
| Active substance | Tetracosactide |
|---|---|
| ATC code | H01AA02 |
| AHFS class | 68:04.00 ; 36:04.00 |
| 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) | 00253952 |
|---|---|
| DIN (unpadded, as printed on some documents) | 253952 |
| Brand name | SYNACTHEN DEPOT |
| Generic / active ingredient | TETRACOSACTIDE (TETRACOSACTIDE ZINC HYDROXIDE) : 1 MG |
| Market authorization holder | ATNAHS PHARMA UK LIMITED |
| Health Canada schedule | Prescription |
| ATC code | H01AA02 |
| ATC anatomical main group | H — Systemic hormonal preparations |
| ATC therapeutic subgroup | H01AA |
| Current status | DORMANT |
| Status date | 09-Jul-2021 |
| Original market date | 1973-12-31 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Diagnostic Use for the Investigation of Adrenocortical Insufficiency: - 5-hour test: 1 mg SYNACTHEN DEPOT intramuscularly (I.M.) at about 10 a.m. Plasma cortisol estimated before and 4-6 hours after injection. - 30-Minute Screening Test: 1 mg SYNACTHEN DEPOT I.M. after blood sample at time 0. Further blood sample 30 minutes after injection. - 3-Day Test (Procedure A): 30-minute test on day 1. 1 mg SYNACTHEN DEPOT I.M. on days 2 and 3. Second 30-minute test on day 4. - 3-Day Test (Procedure B): Urinary cortisol levels determined on 24-hour collections for 5 days. 1 mg SYNACTHEN DEPOT I.M. daily from day 3. Therapeutic Use: - Average dose: 0.5 - 1 mg I.M. twice a week, adjusted to individual requirements. - Acute cases or after prolonged steroid therapy: 1 mg I.M. daily for three days. Interval extended as response is obtained. - Maintenance: 0.5 - 1 mg every 2 or 3 days, or 2 mg weekly or longer intervals. Pediatric Dosage (3-15 years old): - 3-6 years: Initial 0.25 - 0.5 mg/day I.M. Maintenance 0.25 - 0.5 mg every 2 - 8 days. - 7-15 years: Initial 0.25 - 1 mg/day I.M. Maintenance 0.25 - 1 mg every 2 - 8 days. Route of Administration: Intramuscular injection, slowly and deeply into the gluteal region. Ampoules should be slightly shaken until suspension is uniform.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Known or suspected hypersensitivity to tetracosactide (cosyntropin) and/or ACTH of animal origin or any excipients. Must not be used to treat asthma or other allergic conditions due to increased risk of anaphylactic reactions. Contraindicated in premature babies and neonates (less than 1 month) due to benzyl alcohol content. Acute psychosis. Untreated bacterial, fungal and viral infections. Active or latent peptic ulcer. Refractory congestive heart failure. Cushing's syndrome. Treatment of primary adrenocortical insufficiency. Adrenogenital syndrome. Not to be given intravenously.
Warnings and precautions
SYNACTHEN DEPOT MUST NOT BE GIVEN INTRAVENOUSLY. BENZYL ALCOHOL: Due to the presence of benzyl alcohol, SYNACTHEN DEPOT is not recommended in infants and children between 1 month of age and 3 years old, as it may cause toxic reactions and allergic reactions (gasping syndrome) and may result in death. It is contraindicated in premature babies and neonates (less than 1 month). Anaphylactic reactions: In rare cases, particularly in patients subject to asthma and/or other forms of allergy, severe anaphylactic reactions may occur, usually within 30 minutes after administration. SYNACTHEN DEPOT must not be used to treat asthma or other allergic conditions due to this increased risk. Conditions requiring careful consideration: If used in non-specific ulcerative colitis, diverticulitis, recent intestinal anastomosis, renal insufficiency, hypertension, thromboembolic tendencies, acute or chronic infections (especially varicella or vaccinia), exanthematous and fungal diseases, osteoporosis, and myasthenia gravis, risks should be weighed against benefits. Sodium and water retention: Administration for three consecutive days may cause sodium and water retention with risk of edema. Cushing's syndrome exacerbation: Marked and prolonged increase in circulating corticosteroid levels in patients with bilateral adrenal hyperplasia can cause severe exacerbation of Cushing's syndrome symptoms. Adrenal crisis: On extremely rare occasions, adrenal crisis has supervened during prolonged ACTH stimulation in patients with marked adrenal insufficiency. Steroid cover (e.g., 1 mg dexamethasone daily) may be given during the 3 days of SYNACTHEN DEPOT administration for diagnostic tests to prevent this. Hypersensitivity reactions: Allergic reactions may occur, tending to be more severe in patients susceptible to allergies (especially asthma). Injections should be given under medical supervision, and the patient observed for about 1 hour. Self-injection is not recommended. If prodromal signs occur, stop treatment. Local or systemic hypersensitivity reactions (marked redness/pain at injection site, dizziness, nausea, vomiting, urticaria, pruritus, flushings, severe malaise, dyspnea, angioneurotic edema or Quincke's edema) require discontinuation of tetracosactide and avoidance of all ACTH preparations in the future. Live virus immunization: Must not be undertaken during treatment due to decreased antibody response and possible neurological complications.
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
1 of 2 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| CORTROSYN INJ 0.25MG | 0.25 MG | POWDER FOR SOLUTION | AMPHASTAR PHARMACEUTICALS, INC. | MARKETED | 00022381 |
2 · Same class — other molecules in ATC H01AA
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Tetracosactide | CORTROSYN INJ 0.25MG · SYNACTHEN DEPOT | 2 | 1 | Yes |
| Corticotrophin | ACTHAR GEL HP INJ 40UNIT/ML · ACTHAR POWDER INJ 40UNIT/VIAL | 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 H01A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| H01AC | Mecasermin · Somapacitan · Somatrem · Somatrogon · Somatropin · +1 more | 61 | 27 |
| H01AX | Pegvisomant | 5 | 5 |
| H01AB | Thyrotrophin Alfa | 1 | 1 |
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 SYNACTHEN DEPOT called?
Also recorded in Canada as: CORTROSYN (US), SYNACTHEN (UK), SYNACTHEN (EU), COSYNTROPIN (US), TETRACOSACTIDE (UK), TETRACOSACTIDE (GLOBAL), CORTROPHIN-S (JP).
The same molecule, Tetracosactide, 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 |
|---|---|---|
| Synachten | Latin | Iceland |
| Synacthen | Latin | South Africa |
| SYNACTHENE | 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?
This DIN is dormant — it holds a Health Canada authorization but is not currently being marketed in Canada, so it cannot simply be ordered from Canadian stock. Where a patient need exists, supply may be possible through exceptional importation or the Special Access Programme, subject to Health Canada's requirements and the prescriber's application. Nexara can advise on the route and on marketed alternatives.
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.