Download Announcement (PDF)Daunorubicin Injection 50mg/10 mL
About Generic Medical Partners
Generic Medical Partners (GMP) is a Canadian pharmaceutical company specializing in high-quality generic medicines since 2008. Headquartered in Toronto, GMP builds on a legacy of innovation, trust, and excellence, founded by Tarik Henein, who brings over 40 years of international pharmaceutical expertise, alongside the late Dr. Rafick Henein, a respected pioneer with over 55 years of leadership in the generic sector.
GMP connects efficient international pharmaceutical manufacturers and developers with the Canadian market by facilitating product registration with Health Canada and enabling distribution across all major sales channels. With a growing portfolio spanning oncology injectables, hospital injectables, oral medications, and ophthalmic products, GMP plays a key role in improving healthcare accessibility, with a clear goal to innovate for Canada.
Product Description & Introduction
Daunorubicin is an anthracycline chemotherapy agent indicated for the treatment of acute leukemias, including acute myelogenous leukemia (AML) and acute lymphocytic leukemia (ALL).
Generic Medical Partners is introducing Daunorubicin 50 mg / 10 mL to the Canadian market as part of its expanding oncology portfolio. The ready-to-use solution format features a larger 50mg / 10 mL vial, maintaining the same established strength while offering increased preparation convenience compared to traditional smaller vial size and powder formats, supporting efficiency in hospital pharmacy settings.
| Strength | 50mg / 10mL (5 mg / mL) |
| Format | Ready-to-use sterile solution |
| Pack Size | 1 vial per carton (10mL single-use vial) |
Why This Product Matters
The introduction of Daunorubicin injection USP 50 mg / 10 mL addresses key operational needs within hospital oncology settings. The larger 50mg / 10 mL vial format maintains the same strength while offering a more practical presentation, supporting efficient dose preparation and reducing the need for multiple vials in certain use cases.
As a ready-to-use solution, this product eliminates the need for reconstitution, helping to reduce preparation time and minimize handling steps. This contributes to improved workflow efficiency and consistency within oncology pharmacy environments, particularly in high-volume settings where streamlined processes are critical.
Key Benefits
- Ready to use sterile solution (no reconstitution required)
- Increased preparation convenience
- Reduced compounding steps
- Reduction in vial handling
- Hospital-ready presentation
Availability & Distribution
Daunorubicin Injection USP 50 mg / 10mL will be offered to all established hospital buying groups and made available across Canada through established national and provincial distribution channels, including CPDN Distribution Centres, directly from GMP Customer Service.
Ordering can be completed directly through CPDN, or by contacting GMP Customer Service at customerservice@gmprx.com.
Logistics & Customer Support
Generic Medical Partners supports reliable and responsive supply through a national distribution network, with delivery available within 24 hours OR by the following day where applicable. Bilingual (English/French) customer support is provided through Accuristix GMP Customer Service to ensure accessibility across all regions, including the Quebec market.
Dedicated support is available for hospital pharmacies and buying groups to assist with product inquiries, ordering, and ongoing supply needs.
Dosage & Administration
Daunorubicin Injectable Solution is reserved mainly for the initial therapy of acute leukemia and other forms of malignant tumors which are sensitive to the drug.
It is administered by the I.V. route only. Daunorubicin Injectable Solution is injected into the tubing of a running infusion of 100 or 250 mL isotonic solution. The infusion is performed rapidly to avoid local stasis.
Initial treatment
A) Daunorubicin Injectable Solution alone Acute lymphoblastic leukemia – Daunorubicin Injectable Solution is instituted at a daily dose of 1 mg/kg (30 mg/m2) over a period of 3 to 6 days. If, after this first administration, the number of white cells is less than 1 500, maintenance therapy is begun. However, if a partial remission is obtained, but the number of leukocytes is greater than 1 500, treatment should be repeated 1 or more times, as necessary, based on the hematological response. As soon as the remission is obtained, maintenance treatment can be started. The total dose during the initial treatment should not, as a rule, exceed 20 mg/kg.
Acute myeloblastic, granulocytic and promyelocytic leukemias – A daily dose of 2 mg/kg (60 mg/m2) is administered for a period of 3 to 6 days, plus 1 or 2 supplementary injections which are given a few days after a remission is obtained if the blasts have not completely disappeared from the peripheral blood or marrow. The total dose varies from 3 to 22.5 mg/kg (90 to 600 mg/m2). During the initial therapy, blood should be examined every day and marrow 2 or 3 times a week.
B) Combination therapy
When Daunorubicin Injectable Solution is given in association with other antileukemic medication, it must be given every 2 or 3 days to avoid complete marrow aplasia; the treatment extends for a period of 2 to 4 weeks. It is recommended that hemograms be conducted before each injection and if they manifest a severe perturbation of the blood count, the medication should be stopped.
The dosage is from 1 mg/kg per injection every 2 or 3 days up to a total of 12 mg/kg. If only an incomplete remission is obtained after this treatment, Daunorubicin Injectable Solution can be continued up to the maximum dose of 20 mg/kg which must not be exceeded during any one treatment period. As soon as a complete remission is obtained the drug is withdrawn and maintenance treatment instituted.
Maintenance therapy
Any standard chemotherapeutic agent may be employed during maintenance therapy. If the marrow is not completely ablastic in the course of 4 weeks, a weekly injection of 1 mg/kg Daunorubicin Injectable Solution may be given.
Cumulative Doses
As a rule the total cumulative dose should not exceed 25 mg/kg, e.g., approximately 500 mg/m2 for a child of 10 kg; 600 mg/m2 for a child of 20 kg; 750 mg/m2 for a child of 30 kg and 900 mg/m2 for an adult of 60 kg. In patients who have become resistant to all therapy and for whom a final effort is required to induce a remission, the total cumulative dose can be extended to 30 mg/kg.
Chronic Myeloid Leukemia
Injections of 1 to 2 mg/kg may be administered every day or every other day up to a total dose of 6 to 12 mg/kg.
| GTIN | 870573001205 |
| DIN | 02501481 |
| CPDN | 901205 |