Filters
Custom request?
Type
Production region
Qualifications
Country of origin
Daunorubicin API Manufacturers & Suppliers
8 verified results
All Daunorubicin data. Full access. Full negotiation power
Commercial-scale Suppliers
All certificates
Employees: 200+
All certificates
All certificates
All certificates
All certificates
All certificates
All certificates
All certificates
Total market transparency
Supplier trade data access
Buyer / supplier flow comparison
Daunorubicin | CAS No: 20830-81-3 | GMP-certified suppliers
A medication that supports remission induction in acute nonlymphocytic and lymphocytic leukemias, including therapy-related and myelodysplasia-associated acute myeloid leukemia.
Therapeutic categories
Primary indications
- For remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults
- Daunorubicin is indicated in combination with [cytarabine] for the treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older
Product Snapshot
- Daunorubicin is available as an injectable small molecule formulation in various powder and solution forms for intravenous administration
- It is primarily used in the induction of remission for acute nonlymphocytic leukemia, acute lymphocytic leukemia, and therapy-related acute myeloid leukemia in both adults and pediatric patients
- Daunorubicin holds regulatory approval for use in the US, Canada, and EU markets
Clinical Overview
Pharmacologically, daunorubicin belongs to the class of anthracyclines, characterized by a tetracenequinone polyketide ring linked to a sugar moiety via glycosidic bonds. Its cytotoxic effect is mediated primarily through intercalation into DNA base pairs, disrupting DNA structure and function. Furthermore, daunorubicin inhibits the enzyme topoisomerase II by stabilizing the DNA-topoisomerase II cleavage complex, thereby preventing the religation of DNA strands during replication. This results in the arrest of cellular proliferation and promotes apoptosis. The drug also contributes to cytotoxicity through the generation of reactive oxygen species, increasing oxidative stress within malignant cells.
Key pharmacokinetic parameters include metabolism predominantly via hepatic pathways involving cytochrome P-450 enzymes, especially CYP3A4, with substrates and inhibitors of this enzyme affecting daunorubicin exposure. The compound is a substrate for efflux transporters including P-glycoprotein and BCRP/ABCG2, which may influence tissue distribution and resistance profiles.
Safety concerns with daunorubicin administration center on its narrow therapeutic index. Myelosuppression is a dose-limiting toxicity manifesting as cytopenias. Hepatotoxicity and local extravasation injuries are also significant risks. Cardiotoxicity, including congestive heart failure, is associated with cumulative lifetime exposure and necessitates close cardiac monitoring during therapy.
Daunorubicin is marketed under several brand names globally and is integral in chemotherapy regimens for hematological malignancies.
For API procurement, stringent quality control is essential to ensure purity and batch consistency given daunorubicin’s toxicity and narrow therapeutic margin. High-performance analytical characterization, compliance with pharmacopeial standards, and assurance of supply chain integrity are critical considerations in sourcing.
Identification & chemistry
| Generic name | Daunorubicin |
|---|---|
| Molecule type | Small molecule |
| CAS | 20830-81-3 |
| UNII | ZS7284E0ZP |
| DrugBank ID | DB00694 |
Pharmacology
| Summary | Daunorubicin is an anthracycline antineoplastic agent that exerts cytotoxic effects primarily by intercalating into DNA and inhibiting topoisomerase II enzymes, disrupting DNA replication and repair. Its mechanism also involves the generation of reactive oxygen species, contributing to oxidative stress and cell death. The drug targets DNA and topoisomerase II alpha and beta isoforms, exhibiting antimitotic activity used primarily in hematologic malignancies such as acute myeloid and lymphocytic leukemias. |
|---|---|
| Mechanism of action | Daunorubicin has antimitotic and cytotoxic activity through a number of proposed mechanisms of action: Daunorubicin forms complexes with DNA by intercalation between base pairs, and it inhibits topoisomerase II activity by stabilizing the DNA-topoisomerase II complex, preventing the religation portion of the ligation-religation reaction that topoisomerase II catalyzes. |
| Pharmacodynamics | Daunorubicin is an anthracycline antibiotic and antineoplastic agent. It acts by inhibiting cellular reproduction through interference with DNA replication although it may contribute to the induction of cell death by increasing oxidative stress through the generation of reactive oxygen species and free radicals. As an antineoplastic agent, daunorubicin carries significant toxicities including cytopenias, hepatotoxicity, and extravasation reactions. Like other anthracyclines, daunorubicin also exhibits cardiotoxicity in proportion with the cumulative dose received over time. |
Targets
| Target | Organism | Actions |
|---|---|---|
| DNA | Humans | intercalation |
| DNA topoisomerase 2-alpha | Humans | inhibitor |
| DNA topoisomerase 2-beta | Humans | inhibitor |
ADME / PK
| Absorption | Daunorubicin was found to have a tmax of 2 h and a cmax of 24.8 μg/mL after a 90 min infusion of the liposomal formulation at a dose of 44 mg/m<sup>2</sup>. |
|---|---|
| Half-life | Daunorubicin has been determined to have a terminal half-life of 18.5 h (+/- 4.9). Daunorubicinol, the primary active metabolite has been determined to have a terminal half-life of 26.7 h (+/- 12.8). The mean half-life of elimination of liposomal daunorubicin has been reported to be 22.1 h in pharmacokinetic studies and 31.5 h in official FDA labeling.[A237405 ,L32843] |
| Route of elimination | Daunorubicin is eliminated hepatically. 40% of daunorubicin is excreted in the bile while 25% is excreted in an active form (daunorubicin or daunorubicinol) in the urine. In the liposomal formulation, only 9% of active molecules are excreted in the urine. |
| Volume of distribution | Daunorubicin has a steady-state volume of distribution of 1.91 L/m<sup>2</sup> reported with the liposomal formulation. The average volume of distribution reported for the liposomal formulation is 6.6 L. |
| Clearance | Daunorubicin has a clearance of 68.4 mL/h/m<sup>2</sup> determined using the liposomal formulation. |
Formulation & handling
- Daunorubicin is a small molecule anthracycline administered exclusively via intravenous or parenteral routes as a solution or powder for reconstitution.
- The compound exhibits moderate water solubility and is formulated for lyophilized or ready-to-use injectable preparations, requiring careful handling to maintain stability.
- Due to its chemical class and formulation, it is not intended for oral administration and may require protection from light and temperature variations during storage and handling.
Regulatory status
| Lifecycle | The API is marketed in the US, Canada, and EU, with key US patents expiring between 2025 and 2029, indicating a mid to late lifecycle stage with potential for generic entry in the coming years. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Daunorubicin is manufactured by multiple originator companies with diverse roles, including both original drug makers and generic producers. Its branded products are distributed across key markets such as the US, Canada, and the EU. Patent expirations ranging from 2025 to 2029 indicate staggered timelines for potential generic competition in the US market. |
|---|
Daunorubicin is a type of Anthracycline Derivatives
Anthracycline derivatives are a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs). These compounds are structurally derived from anthracyclines, which are natural antibiotics produced by certain strains of Streptomyces bacteria. Anthracycline derivatives exhibit potent anticancer properties and are commonly used in the treatment of various types of cancer, including breast cancer, leukemia, and lymphomas.
These APIs exert their therapeutic effects by interfering with the DNA replication process in cancer cells. They inhibit the activity of topoisomerase enzymes, which are responsible for unwinding and rewinding DNA strands during replication. By disrupting this process, anthracycline derivatives prevent cancer cells from dividing and multiplying, ultimately leading to their death.
Doxorubicin and daunorubicin are two well-known examples of anthracycline derivatives. These drugs have demonstrated remarkable efficacy in the treatment of cancer and are considered key components of chemotherapy regimens. However, their clinical use is limited by potential side effects, including cardiotoxicity and myelosuppression.
Despite these challenges, anthracycline derivatives continue to play a crucial role in oncology due to their proven efficacy against various types of cancer. Ongoing research aims to develop modified derivatives with reduced toxicity and enhanced therapeutic benefits. By harnessing the potential of these APIs, researchers and pharmaceutical companies strive to improve cancer treatment outcomes and enhance patient well-being.
Daunorubicin (Anthracycline Derivatives), 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.
Daunorubicin API manufacturers & distributors
Compare qualified Daunorubicin API suppliers worldwide. We currently have 8 companies offering Daunorubicin API, with manufacturing taking place in 6 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 |
|---|---|---|---|---|---|
| DZD Heze Pharma | Producer | China | China | CoA, WC | 3 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Meiji Seika | Producer | Japan | Japan | CEP, CoA, FDA, USDMF | 5 products |
| Microbiopharm Japan | Producer | Japan | Japan | CoA, USDMF | 5 products |
| Sicor | Producer | Italy | Italy | CEP, CoA, FDA, GMP | 47 products |
| Sterling Biotech | Producer | India | India | CoA, GMP, WC | 5 products |
| Veeprho Group | Producer | Czech Republic | Czech Republic | CoA | 140 products |
| Zhejiang Hisun Pharma | Producer | China | China | CEP, CoA, GMP, USDMF, WC | 69 products |
When sending a request, specify which Daunorubicin 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 Daunorubicin 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.
