Dacarbazine 100mg/20mL
| Product Overview |
| Generic Name | Dacarbazine 100mg/20mL |
| Brand Name(s) | DTIC‑Dome; Bazipar; Cedcozine; Dacarba; Dacarex; Dacin; Dacmed; Darbazine; Dazine; |
| Form | Powder for injection (IV) |
| Strength | 100 mg |
| Therapeutic Class | Chemotherapy (Melanoma, Hodgkin’s lymphoma); second-line soft tissue sarcoma |
| ATC Code | L01AX03 |
| Manufacturing & Regulatory |
| Manufacturer | Faulding Pharmaceuticals Plc (UK); generic producers: Alkem, Intas, |
| Country | India/USA/EU |
| GMP Compliance | GMP-certified |
| DMF/CEP | Type II DMFs |
| COFEPRIS | Under Registration (2025) |
| Free Sale Certificate | Available from supplier on request |
| Logistics & Export |
| MOQ | 10 Vials |
| Shelf Life | 24–36 months standard for powder vials |
| Storage | Store = 25 °C, protect from light |
| Incoterms | EXW/FOB/CIF negotiable |
| Lead Time | 7 - 10 Business Days |
| Documentation |
| Certificate of Analysis (COA) | Provided per batch |
| SDS | Manufacturer provides standard SDS (biologic/aqueous injectable) |
| CTD Summary | Available from manufacturer/distributor under confidentiality |
Description
Indicated for metastatic melanoma (single‑agent) and Hodgkin’s disease (combo regimens, e.g., ABVD); category L01AX03 – alkylating agent. “Dacarbazine is an intravenous alkylating agent used as single-agent therapy in metastatic malignant melanoma and as part of combination chemotherapy (e.g., ABVD regimen) for Hodgkin’s disease. It acts through DNA cross-linking and purine analog interference, reducing tumor proliferation
COFEPRIS APPROVAL TO: Mac-Chem Products (India) Pvt. Ltd.
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