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Epirubicin | CAS No: 56420-45-2 | GMP-certified suppliers
A medication that provides adjuvant chemotherapy to reduce breast cancer recurrence in patients with axillary lymph node involvement after tumor resection.
Therapeutic categories
Primary indications
- For use as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer
Product Snapshot
- Epirubicin is available as an injectable formulation, including lyophilized powder and solution for parenteral administration
- It is primarily used as a component of adjuvant therapy for breast cancer patients with axillary node tumor involvement post-resection
- Epirubicin is approved for use in the US and Canadian markets
Clinical Overview
Pharmacologically, epirubicin exerts antitumor effects through multiple mechanisms centered on interference with DNA synthesis and function. It intercalates between DNA base pairs, disrupting the double helix structure and impeding replication and transcription. A key mode of action involves inhibition of topoisomerase II by stabilizing the cleavable complex between the enzyme and DNA. This prevents DNA strand religation after enzymatic cleavage, leading to accumulation of DNA breaks. Additional effects include inhibition of DNA helicase activity, suppression of polymerase activity, alterations in gene expression regulation, and generation of free radicals that induce DNA damage. Epirubicin’s cytotoxicity is not cell cycle phase-specific, which contributes to its broad antitumor activity across various malignancies.
Following administration, epirubicin undergoes hepatic metabolism primarily via UDP-glucuronosyltransferase enzyme UGT2B7. The compound and its metabolites are predominantly excreted in bile and urine. Its pharmacokinetics are characterized by a narrow therapeutic index, necessitating careful dose adjustment and monitoring.
Safety considerations for epirubicin include dose-limiting toxicities such as myelosuppression and cardiotoxicity, the latter potentially leading to congestive heart failure, especially with cumulative dosing. Hepatotoxicity and immunosuppression are also clinically relevant. Due to these risks, epirubicin treatment mandates vigilant cardiac function assessment and hematologic monitoring throughout therapy.
Epirubicin is recognized globally and marketed under various brand names, commonly used in combination chemotherapy regimens for breast and other solid tumors.
For formulation scientists and procurement professionals, sourcing high-quality epirubicin API requires strict adherence to pharmacopeial standards focused on purity, potency, and identification. Given its narrow therapeutic index and toxicity profile, consistent batch-to-batch quality and compliance with Good Manufacturing Practices (GMP) are essential to ensure safe and effective clinical use.
Identification & chemistry
| Generic name | Epirubicin |
|---|---|
| Molecule type | Small molecule |
| CAS | 56420-45-2 |
| UNII | 3Z8479ZZ5X |
| DrugBank ID | DB00445 |
Pharmacology
| Summary | Epirubicin is an anthracycline antineoplastic agent that exerts cytotoxic effects by intercalating into DNA and inhibiting topoisomerase II activity, leading to disruption of DNA replication and transcription. It targets DNA and DNA topoisomerase 2-alpha, resulting in impaired nucleic acid and protein synthesis. Epirubicin demonstrates cell cycle-nonspecific antitumor activity against a broad range of tumors. |
|---|---|
| Mechanism of action | Epirubicin has antimitotic and cytotoxic activity. It inhibits nucleic acid (DNA and RNA) and protein synthesis through a number of proposed mechanisms of action: Epirubicin 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. It also interferes with DNA replication and transcription by inhibiting DNA helicase activity. |
| Pharmacodynamics | Epirubicin is an antineoplastic in the anthracycline class. General properties of drugs in this class include: interaction with DNA in a variety of different ways including intercalation (squeezing between the base pairs), DNA strand breakage and inhibition with the enzyme topoisomerase II. Most of these compounds have been isolated from natural sources and antibiotics. However, they lack the specificity of the antimicrobial antibiotics and thus produce significant toxicity. The anthracyclines are among the most important antitumor drugs available. Doxorubicin is widely used for the treatment of several solid tumors while daunorubicin and idarubicin are used exclusively for the treatment of leukemia. Epirubicin may also inhibit polymerase activity, affect regulation of gene expression, and produce free radical damage to DNA. Epirubicin possesses an antitumor effect against a wide spectrum of tumors, either grafted or spontaneous. The anthracyclines are cell cycle-nonspecific. |
Targets
| Target | Organism | Actions |
|---|---|---|
| DNA | Humans | intercalation |
| DNA topoisomerase 2-alpha | Humans | inhibitor |
ADME / PK
| Absorption | 100% |
|---|---|
| Half-life | Half-lives for the alpha, beta, and gamma phases of about 3 minutes, 2.5 hours and 33 hours, respectively |
| Protein binding | 77% |
| Metabolism | Extensively and rapidly metabolized in the liver. Epirubicin is also metabolized by other organs and cells, including red blood cells. The four main metabolic routes are: (1) reduction of the C-13 keto-group with the formation of the 13(S)-dihydro derivative, epirubicinol; (2) conjugation of both the unchanged drug and epirubicinol with glucuronic acid; (3) loss of the amino sugar moiety through a hydrolytic process with the formation of the doxorubicin and doxorubicinol aglycones; and (4) loss of the amino sugar moiety through a redox process with the formation of the 7-deoxy-doxorubicin aglycone and 7-deoxy-doxorubicinol aglycone. Epirubicinol exhibits in vitro cytoxic activity (~10% that of epirubicin), but it is unlikely to reach sufficient concentrations in vivo to produce cytotoxic effects. |
| Route of elimination | Epirubicin and its major metabolites are eliminated through biliary excretion and, to a lesser extent, by urinary excretion. |
| Volume of distribution | * 21 ± 2 L/kg [60 mg/m2 Dose] * 27 ± 11 L/kg [75 mg/m2 Dose] * 23 ± 7 L/kg [120 mg/m2 Dose] * 21 ± 7 L/kg [150 mg/m2 Dose] |
| Clearance | * 65 +/- 8 L/hour [Patients1 with Solid Tumors Receiving Intravenous Epirubicin 60 mg/m2] * 83 +/- 14 L/hour [Patients1 with Solid Tumors Receiving Intravenous Epirubicin 75 mg/m2] * 65 +/- 13 L/hour [Patients1 with Solid Tumors Receiving Intravenous Epirubicin 120 mg/m2] * 69 +/- 13 L/hour [Patients1 with Solid Tumors Receiving Intravenous Epirubicin 150 mg/m2] |
Formulation & handling
- Epirubicin is formulated primarily for parenteral administration including intravenous, intra-arterial, intravesical, and intramuscular routes.
- It is a small molecule anthracycline with moderate water solubility suitable for lyophilized powder reconstitution or ready-to-use solutions.
- Handling considerations include ensuring adequate hydration of patients to promote renal excretion of uric acid and monitoring for potential instability in solution form.
Regulatory status
| Lifecycle | The API is entering a mature market phase in the US and Canada, with key patents having expired or approaching expiration, allowing for increased generic competition. Product availability is established across both regions, reflecting a stabilized commercial landscape. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Epirubicin is supplied by multiple manufacturers and packagers, including original innovators and numerous generic producers, indicating a competitive manufacturing landscape. Branded products are primarily present in the US and Canadian markets. Patent expirations have led to existing generic competition, reflected by the wide range of generic manufacturers active in the supply chain. |
|---|
Safety
| Toxicity | bone marrow aplasia, grade 4 mucositis, and gastrointestinal bleeding |
|---|
- Potential for severe bone marrow suppression including aplasia
- Implement appropriate exposure controls
- Risk of grade 4 mucositis
Epirubicin 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.
Epirubicin (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.
Epirubicin API manufacturers & distributors
Compare qualified Epirubicin API suppliers worldwide. We currently have 11 companies offering Epirubicin API, with manufacturing taking place in 7 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 |
|---|---|---|---|---|---|
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| DZD Heze Pharma | Producer | China | China | CEP, CoA, GMP | 3 products |
| Flavine | Distributor | Germany | Unknown | CoA | 83 products |
| Heraeus | Producer | Germany | Germany | CEP, CoA, FDA, GMP | 10 products |
| Humble Healthcaare | Producer | India | India | CoA | 30 products |
| Intas Pharma | Producer | United Kingdom | India | CoA, GMP, WC | 30 products |
| Microbiopharm Japan | Producer | Japan | Japan | CEP, CoA, FDA, JDMF, USDMF | 5 products |
| Shandong N.T. Pharma | Producer | China | China | CoA, USDMF | 12 products |
| Sterling Biotech | Producer | India | India | CEP, CoA, GMP, WC | 5 products |
| Synbias Pharma | Producer | Switzerland | Switzerland | CoA, JDMF, USDMF | 7 products |
| Zhejiang Hisun Pharma | Producer | China | China | CoA, JDMF, USDMF, WC | 69 products |
When sending a request, specify which Epirubicin 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 Epirubicin 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.
