TARO-SUNITINIB 50 MG
SUNITINIB (SUNITINIB MALATE) : 50 MG · DIN 02524082 · TARO PHARMACEUTICALS INC
Health Canada status: MARKETED
What is TARO-SUNITINIB?
TARO-SUNITINIB 50 MG contains SUNITINIB (SUNITINIB MALATE) : 50 MG. It is listed in the Health Canada Drug Product Database under DIN 02524082, held by TARO PHARMACEUTICALS INC, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 20-Sep-2022. 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.
What is TARO-SUNITINIB used for?
Treatment of gastrointestinal stromal tumour (GIST), metastatic renal cell carcinoma (MRCC), and unresectable locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumours.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Product details and regulatory record
| DIN | 02524082 |
|---|---|
| Brand name | TARO-SUNITINIB |
| Generic / active ingredient | SUNITINIB (SUNITINIB MALATE) : 50 MG |
| Manufacturer | TARO PHARMACEUTICALS INC |
| Strength | 50 MG |
| Dosage form | CAPSULE |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | L01EX01 SUNITINIB |
| AHFS class | 10:00.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 20-Sep-2022 |
| Original market date | 2022-09-20 00:00:00 |
How is it administered?
Administered orally. Dosage may be interrupted or reduced for management of toxicities such as hypertension or LVEF decreases. Consult full monograph for specific indications.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text (refers to Storage and Stability section).
How is it supplied?
Not explicitly detailed in provided text (refers to Packaging section). Typically available in 12.5 mg, 25 mg, 37.5 mg, and 50 mg strengths.
Contraindications
Hypersensitivity to sunitinib malate or any component of the formulation. Contraindicated in pregnant women.
Warnings and precautions
Serious warnings: Tumour hemorrhage, LVEF decrease, hypertension, QT prolongation, cardiomyopathy, arterial thromboembolic events, TMA, hepatotoxicity, and renal failure.
What can be used instead?
Other Canadian products sharing ATC code L01EX01 SUNITINIB. 18 of 26 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| AURO-SUNITINIB | 12.5 MG | CAPSULE | AURO PHARMA INC | MARKETED | DIN 02532190 |
| AURO-SUNITINIB | 25 MG | CAPSULE | AURO PHARMA INC | MARKETED | DIN 02532204 |
| AURO-SUNITINIB | 50 MG | CAPSULE | AURO PHARMA INC | MARKETED | DIN 02532220 |
| NAT-SUNITINIB | 12.5 MG | CAPSULE | NATCO PHARMA (CANADA) INC | MARKETED | DIN 02552892 |
| NAT-SUNITINIB | 25 MG | CAPSULE | NATCO PHARMA (CANADA) INC | MARKETED | DIN 02552906 |
| NAT-SUNITINIB | 50 MG | CAPSULE | NATCO PHARMA (CANADA) INC | MARKETED | DIN 02539284 |
| SANDOZ SUNITINIB | 12.5 MG | CAPSULE | SANDOZ CANADA INCORPORATED | MARKETED | DIN 02532840 |
| SANDOZ SUNITINIB | 25 MG | CAPSULE | SANDOZ CANADA INCORPORATED | MARKETED | DIN 02532867 |
| SANDOZ SUNITINIB | 50 MG | CAPSULE | SANDOZ CANADA INCORPORATED | MARKETED | DIN 02532883 |
| SUTENT | 12.5 MG | CAPSULE | PFIZER CANADA ULC | MARKETED | DIN 02280795 |
Who else supplies SUNITINIB worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. SUNITINIB appears in 2388 registered pack listings across 14 markets, published on 11 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.
Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.
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.
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.
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.