Description
Daunorubicin Hydrochloride Injection
Healthy Inc is a specialized global supplier and exporter of high-potency anthracycline antibiotics. We provide high-purity Daunorubicin Hydrochloride Injection (20 mg), sourced from WHO–GMP certified sterile cytotoxic facilities. This “Leukemia Induction” specialist is a top export to hematology wards, bone marrow transplant units, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the cornerstone of induction chemotherapy for Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia (ALL).
Product Overview
This formulation contains Daunorubicin Hydrochloride, an anthracycline antibiotic produced by Streptomyces peucetius.
The “Leukemia” Specialist:
- Mechanism (The “Intercalator”): Daunorubicin works by intercalating between DNA base pairs, uncoiling the DNA helix. It also inhibits the enzyme Topoisomerase II, preventing DNA resealing during replication. This causes DNA fragmentation and cell death in rapidly dividing leukemic blasts.
- Induction Therapy: It is the “D” in the standard “7+3” regimen for AML (7 days of Cytarabine + 3 days of Daunorubicin), which is the global gold standard for inducing remission.
- Vesicant Potency: It is a potent vesicant (blistering agent). Strict care is required during administration to prevent severe tissue necrosis.
Product Composition & Strength
We supply this product as a Sterile Lyophilized Powder for Injection in red-capped glass vials.
| Active Ingredient | Strength | Appearance |
|---|---|---|
| Daunorubicin Hydrochloride USP/BP | Equivalent to 20 mg Daunorubicin | Red-Orange Lyophilized Cake |
| Excipients | Mannitol | Bulking Agent |
*Pack Sizes: Tray of 1 Vial. (Cytotoxic Packaging).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.20.99 (Medicaments containing other antibiotics) |
| Dosage Form | Lyophilized Powder (Reconstitute & Dilute) |
| Packaging | Type I Glass Vial (Sterile) with Cytotoxic Warning |
| Storage | Store below 25°C. Protect from Light. Reconstituted solution is stable for 24 hours at room temp (48h if refrigerated). |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Containment Technology: Manufactured in dedicated isolator lines to prevent cross-contamination with non-cytotoxic drugs. Operators use full PPE and closed-system transfer devices (CSTD) during filling.
- Rapid Reconstitution: Our “fluffed” lyophilization cycle ensures the red cake dissolves instantly upon adding saline, minimizing handling time and exposure risk for the pharmacist.
Therapeutic Indications (Human Use)
Indicated for the induction of remission in:
- Acute Myeloid Leukemia (AML): Adults and children (“7+3” Regimen).
- Acute Lymphoblastic Leukemia (ALL): Induction therapy in combination with Vincristine and Prednisone.
- Chronic Myelogenous Leukemia (CML): Blast phase.
Dosage & Administration
Recommended Dosage (Strictly as per Hematologist):
- Route: Intravenous (IV) Infusion ONLY. (NEVER IM or SC).
- AML Induction (Adults): 45 mg/m² daily for 3 days (Days 1, 2, 3) combined with Cytarabine.
- ALL Induction (Children): 25 mg/m² weekly.
- Administration: Reconstitute with 4ml WFI. Inject slowly into the tubing of a freely running IV infusion of Saline/Dextrose over 2-3 minutes.
- Extravasation Protocol: If leakage occurs, STOP IMMEDIATELY. Apply ice packs. Consider Dexrazoxane.
Safety Warnings (CRITICAL):
- Cardiotoxicity (Heart Damage): Daunorubicin causes dose-dependent, cumulative heart damage (Cardiomyopathy/CHF). Maximum lifetime cumulative dose is 550 mg/m². Baseline LVEF (Echocardiogram) is mandatory before starting.
- Myelosuppression: Severe leukopenia, thrombocytopenia, and anemia are expected. Patient requires isolation and blood product support.
- Red Urine: Warn the patient that urine will turn red for 1-2 days after injection (harmless drug excretion).
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Sterile Injectables, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.
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