Dacarbazine Injection

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Dacarbazine for injection (commonly known by the brand name DTIC-Dome) is an antineoplastic (chemotherapy) agent supplied as a sterile, lyophilised (freeze-dried) powder for reconstitution. It is primarily used to treat metastatic malignant melanoma and Hodgkin’s disease.

Description

Dacarbazine Injection

Healthy Inc is a specialized global supplier and exporter of high-potency lyophilized oncology injectables. We provide high-purity Dacarbazine Injection (200 mg / 500 mg), sourced from WHO–GMP certified sterile cytotoxic facilities. This “Melanoma Gold Standard” is a top export to cancer institutes, government oncology tenders, and hospital pharmacies in Africa, LATAM, and Southeast Asia, serving as the backbone of chemotherapy regimens for Metastatic Malignant Melanoma and Hodgkin’s Lymphoma.


Product Overview

This formulation contains Dacarbazine (DTIC), a synthetic analogue of purine precursors that acts as an alkylating agent.

The “DNA-Blocker” Specialist:

  • Mechanism (Alkylating Agent): Dacarbazine is a prodrug activated in the liver. It functions by methylating DNA (specifically at the O-6 position of guanine), which causes cross-linking of DNA strands. This prevents cell division and triggers apoptosis (cell death) in rapidly dividing cancer cells.
  • Melanoma Standard: It remains the single most active agent approved for metastatic malignant melanoma, often used when immunotherapy is unavailable or has failed.
  • ABVD Regimen: It is the “D” in the famous ABVD chemotherapy protocol (Adriamycin, Bleomycin, Vinblastine, Dacarbazine), which is the curative standard of care for Hodgkin’s Lymphoma.

Product Composition & Strength

We supply this product as a Sterile Lyophilized Powder for Injection in amber glass vials to protect from light.

Active Ingredient Strength Therapeutic Role
Dacarbazine USP/BP (DTIC) 200 mg Vial Standard Dose
Dacarbazine USP/BP (DTIC) 500 mg Vial High Dose / Multi-use
Excipients Citric Acid, Mannitol Stabilizers / pH Adjusters

*Pack Sizes: Tray of 1 Vial, 10 Vials, or Box of 1/10 Vials.


Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Distributors.

HS Code 3004.90.99 (Antineoplastic medicaments)
Dosage Form Lyophilized Powder for Injection
Packaging Amber Type I Glass Vial (Extreme Light Sensitivity)
Storage Store at 2°C to 8°C (Refrigerate). Protect from Light. Do not freeze.
Certificates WHO-GMP, COPP, Free Sale Certificate

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

  • Photo-Degradation Control: Dacarbazine is extremely sensitive to light. Exposure turns the solution from pale yellow to pink/red (indicating toxic degradation products). We manufacture in amber-lit sterile suites and use UV-blocking amber vials to ensure the product remains stable and potent.
  • Lyophilization Excellence: Our advanced freeze-drying cycle ensures a low moisture content (< 1%), producing a cake that reconstitutes instantly without foaming or particulates.

Therapeutic Indications (Human Use)

Indicated for the treatment of:

  • Malignant Melanoma: Metastatic disease (Skin Cancer).
  • Hodgkin’s Lymphoma: As part of the ABVD combination regimen.
  • Soft Tissue Sarcomas: Leiomyosarcoma, fibrosarcoma (Second-line).
  • Neuroblastoma: In combination with other agents.

Dosage & Administration

Recommended Dosage (Strictly as per Oncologist):

  • Route: Intravenous (IV) Infusion ONLY. (Never IM or SC).
  • Melanoma: 2 to 4.5 mg/kg daily for 10 days (repeat every 4 weeks) OR 250 mg/m² daily for 5 days (repeat every 3 weeks).
  • Hodgkin’s Lymphoma: 375 mg/m² on days 1 and 15 of the cycle (in combination with other drugs).
  • Reconstitution: Add Sterile Water for Injection. Further dilute in 250-500ml of 5% Dextrose or Normal Saline.
  • Infusion Time: Administer over 15-30 minutes.

Safety Warnings (CRITICAL):

  • Vesicant (Severe Tissue Damage): Dacarbazine is a vesicant. Extravasation (leakage into surrounding tissue) causes severe pain and necrosis. Stop infusion immediately if burning occurs.
  • Severe Nausea & Vomiting: Highly emetogenic (>90% of patients). Pre-medication with potent antiemetics (Ondansetron/Dexamethasone) is mandatory.
  • Bone Marrow Suppression: Causes delayed leukopenia and thrombocytopenia. Monitor blood counts.
  • Color Check: DO NOT USE if the reconstituted solution is PINK. It must be pale yellow.

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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