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Dacarbazine | CAS No: 4342-03-4 | GMP-certified suppliers
A medication that supports treatment of metastatic malignant melanoma and serves as a secondary-line option for Hodgkin's disease within combination oncology regimens.
Therapeutic categories
Primary indications
- For the treatment of metastatic malignant melanoma
- In addition, dacarbazine is also indicated for Hodgkin's disease as a secondary-line therapy when used in combination with other antineoplastic agents
Product Snapshot
- Dacarbazine is an injectable small‑molecule alkylating agent supplied mainly as powders for reconstitution for IV administration
- It is used for metastatic malignant melanoma and as a secondary-line component in combination regimens for Hodgkin’s disease
- It is approved in the US and Canada, with additional investigational status in some contexts
Clinical Overview
Dacarbazine exhibits cytotoxic activity that is attributed mainly to its alkylating behavior following metabolic activation. Although the precise mechanism is not fully defined, the agent generates reactive intermediates capable of inducing DNA damage. Alternative mechanistic hypotheses include interference with DNA synthesis through purine analog activity and interactions with sulfhydryl-containing cellular components. It is not specific to any cell cycle phase.
After intravenous administration, dacarbazine demonstrates a volume of distribution exceeding total body water, suggesting tissue localization, likely in the liver where metabolic activation occurs. Plasma elimination is biphasic, with an initial half-life of about 19 minutes and a terminal half-life of approximately 5 hours. In patients with combined renal and hepatic impairment, half-lives may be prolonged. Around 40 percent of the administered dose is excreted unchanged in urine within six hours, primarily via renal tubular secretion. Protein binding at therapeutic concentrations is negligible.
Safety considerations include myelosuppression, hepatotoxicity, and gastrointestinal toxicity. As a narrow therapeutic index drug and a substrate of CYP1A2 and CYP2E1, dacarbazine may be susceptible to pharmacokinetic variability and metabolic interactions. Careful dose adjustment and monitoring are required in patients with organ dysfunction. The agent has been used under various brand names globally and has also been investigated in combination with oblimersen for malignant melanoma.
For API procurement, sourcing should prioritize suppliers with validated control of impurity profiles, consistent particle size distribution, and documented handling of light- and temperature-sensitive materials to ensure compliance with regulatory expectations for oncology drug substances.
Identification & chemistry
| Generic name | Dacarbazine |
|---|---|
| Molecule type | Small molecule |
| CAS | 4342-03-4 |
| UNII | 7GR28W0FJI |
| DrugBank ID | DB00851 |
Pharmacology
| Summary | Dacarbazine is an alkylating cytotoxic agent whose antineoplastic activity is attributed to metabolic activation and subsequent DNA damage; additional proposed mechanisms include purine‑analog–mediated inhibition of DNA synthesis and interaction with sulfhydryl-containing molecules. It distributes widely, undergoes biphasic plasma elimination, and is cleared largely as unchanged drug via renal tubular secretion. Its pharmacologic intent is to disrupt DNA integrity and replication in malignant cells in melanoma and in combination regimens for Hodgkin lymphoma. |
|---|---|
| Mechanism of action | The mechanism of action is not known, but appears to exert cytotoxic effects via its action as an alkylating agent. Other theories include DNA synthesis inhibition by its action as a purine analog, and interaction with SH groups. Dacarbazine is not cell cycle-phase specific. |
| Pharmacodynamics | Dacarbazine is a synthetic analog of naturally occurring purine precursor 5-amino-1H-imidazole-4-carboxamide (AIC). After intravenous administration of dacarbazine, the volume of distribution exceeds total body water content suggesting localization in some body tissue, probably the liver. Its disappearance from the plasma is biphasic with initial half-life of 19 minutes and a terminal half-life of 5 hours. 1 In a patient with renal and hepatic dysfunctions, the half-lives were lengthened to 55 minutes and 7.2 hours. 1 The average cumulative excretion of unchanged DTIC in the urine is 40% of the injected dose in 6 hours. 1 DTIC is subject to renal tubular secretion rather than glomerular filtration. At therapeutic concentrations dacarbazine is not appreciably bound to human plasma protein. |
Targets
| Target | Organism | Actions |
|---|---|---|
| DNA | Humans | cross-linking/alkylation |
| DNA polymerase alpha subunit B | Humans | other/unknown |
| 6-phosphogluconate dehydrogenase, decarboxylating | Humans | inhibitor |
ADME / PK
| Absorption | Erratic, slow and incomplete. |
|---|---|
| Half-life | 5 hours |
| Protein binding | Less than 5% |
| Metabolism | Hepatic |
| Route of elimination | Dacarbazine is subject to renal tubular secretion rather than glomerular filtration. In man, dacarbazine is extensively degraded. Besides unchanged dacarbazine, 5-aminoimidazole -4 carboxamide (AIC) is a major metabolite of dacarbazine excreted in the urine. |
Formulation & handling
- Parenteral-only small-molecule alkylating agent supplied as solid powder or lyophilized material requiring reconstitution for intravenous use.
- Hydrolytically sensitive; solutions should be prepared immediately before use and protected from light to minimize degradation.
- Food-related considerations are clinically driven for nausea management and do not impact formulation since no oral administration is used.
Regulatory status
| Lifecycle | I can draft the summary, but I need the patent‑expiry timing (or at least whether key patents have expired) and the name of the API. Please provide those details so the lifecycle statement can be accurate. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Dacarbazine is supplied by multiple manufacturers and packagers, indicating that no single originator dominates current production and that the product functions largely as a generic oncology API. Commercial availability is established in the US and Canada, with no distinct branded market presence beyond non‑differentiated product names. Patent expiry occurred long ago, supporting the broad presence of existing generic competition. |
|---|
Safety
| Toxicity | LD<sub>50</sub>=350mg/kg (orally in mice) |
|---|
- Exhibits acute oral toxicity with an LD50 of ~350 mg/kg in mice, indicating the need for controlled handling to minimize exposure to dust or aerosols
- Classified as a cytotoxic alkylating agent
- May cause mutagenic and hepatotoxic effects in laboratory settings
Good Manufacturing Practices
Active pharmaceutical ingredients are made in GMP-certified manufacturing facilities. GMP stands for Good Manufacturing Practices and is the main standard in the pharmaceutical industry. cGMP or Current GMP means that the company complies with the most recent requirements/version of GMP. The WHO has its own guideline for GMP, the World Health Organization or WHO GMP. The authority that has audited the company can also be from a country like China (Chinese GMP) or from the EU (EU GMP), every authority has different GMP requirements.
Dacarbazine is a type of Alkylating agents
Alkylating agents are a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a significant role in cancer treatment. These compounds possess the ability to attach alkyl groups to the DNA molecule, effectively disrupting its structure and preventing cell replication. This mechanism of action makes alkylating agents potent chemotherapy drugs for various types of cancers.
Alkylating agents are often classified based on their chemical structure, which includes nitrogen mustards, ethylenimines, nitrosoureas, and alkyl sulfonates, among others. Each subclass exhibits unique chemical properties and therapeutic applications. For instance, nitrogen mustards like cyclophosphamide and mechlorethamine are used to treat lymphomas and leukemia, while nitrosoureas such as carmustine and lomustine are effective against brain tumors.
The alkylating agents' mode of action involves the transfer of alkyl groups to cellular components, primarily DNA. This leads to the formation of DNA adducts, cross-links, and DNA strand breaks, ultimately hindering DNA replication and causing cell death. The indiscriminate nature of alkylating agents can also affect healthy cells, leading to various side effects such as bone marrow suppression and gastrointestinal disturbances.
Despite their potential side effects, alkylating agents remain valuable tools in cancer therapy due to their broad spectrum of activity against different types of tumors. Ongoing research focuses on developing more selective and targeted alkylating agents to improve their therapeutic index and minimize adverse effects. The use of alkylating agents in combination with other chemotherapy drugs or radiation therapy is also being explored to enhance treatment outcomes and reduce drug resistance.
In conclusion, alkylating agents are an essential subclass of pharmaceutical APIs widely employed in cancer treatment. Their ability to disrupt DNA structure and impede cell replication makes them effective against various types of tumors, although careful management of side effects is necessary. Ongoing advancements and research continue to refine their therapeutic potential in the fight against cancer.
Dacarbazine (Alkylating agents), classified under Anticancer drugs
Anticancer drugs belong to the pharmaceutical API (Active Pharmaceutical Ingredient) category designed specifically to combat cancer cells. These powerful medications play a crucial role in cancer treatment and are developed to target and destroy cancerous cells, preventing their growth and spread.
Anticancer drugs are classified based on their mode of action and can include various types such as chemotherapy drugs, targeted therapy drugs, immunotherapy drugs, and hormonal therapy drugs. Chemotherapy drugs work by interfering with the cell division process, thereby inhibiting the growth of cancer cells. Targeted therapy drugs, on the other hand, are designed to attack specific molecules or genes involved in cancer growth, minimizing damage to healthy cells. Immunotherapy drugs stimulate the body's immune system to recognize and destroy cancer cells. Hormonal therapy drugs are used in cancers that are hormone-dependent, such as breast or prostate cancer, to block the hormones that fuel cancer cell growth.
These APIs are typically synthesized through complex chemical processes in state-of-the-art manufacturing facilities. Stringent quality control measures ensure the purity, potency, and safety of these drugs. Anticancer APIs undergo rigorous testing and adhere to stringent regulatory guidelines before being approved for clinical use.
Due to their critical role in cancer treatment, anticancer drugs are in high demand worldwide. Researchers and pharmaceutical companies continually strive to develop new and more effective APIs in this category to enhance treatment outcomes and minimize side effects. The ongoing advancements in the field of anticancer drug development offer hope for improved cancer therapies and better patient outcomes.
Dacarbazine API manufacturers & distributors
Compare qualified Dacarbazine API suppliers worldwide. We currently have 6 companies offering Dacarbazine API, with manufacturing taking place in 5 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| AXXO GmbH | Distributor | Germany | European Union | CEP, CoA, GMP, GDP, MSDS, USDMF | 243 products |
| Dalian Wista Pharma Co Lt... | Producer | China | China | CoA | 16 products |
| Heraeus | Producer | Germany | Germany | CEP, CoA, FDA, GMP, USDMF | 10 products |
| Mac Chem Products | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 25 products |
| Suzhou Lixin Pharmaceutic... | Producer | China | China | BSE/TSE, CEP, CoA, EDMF/ASMF, GMP, MSDS | 34 products |
| Vuab Pharma | Producer | Czech Republic | Czech Republic | CEP, CoA, FDA, GMP | 3 products |
When sending a request, specify which Dacarbazine API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Dacarbazine API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Dacarbazine API
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Technical
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Regulatory
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