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Doxorubicin | CAS No: 23214-92-8 | GMP-certified suppliers
A medication that supports treatment of diverse hematologic malignancies and metastatic solid tumors, including leukemias, lymphomas, breast cancer, ovarian cancer, and other advanced pediatric and adult cancers.
Therapeutic categories
Anthracycline Topoisomerase InhibitorAnthracyclinesAnthracyclines and Related SubstancesAntibiotics, AntineoplasticAntineoplastic AgentsAntineoplastic and Immunomodulating Agents
Generic name
Doxorubicin
Molecule type
small molecule
CAS number
23214-92-8
DrugBank ID
DB00997
Approval status
Approved drug, Investigational drug
ATC code
L01DB01
Primary indications
- Doxorubicin is indicated for the treatment of neoplastic conditions like acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin and non-Hodgkin lymphoma, metastatic breast cancer, metastatic Wilms’ tumor, metastatic neuroblastoma, metastatic soft tissue and bone sarcomas, metastatic ovarian carcinoma, metastatic transitional cell bladder carcinoma, metastatic thyroid carcinoma, metastatic gastric carcinoma, and metastatic bronchogenic carcinoma
- Doxorubicin is also indicated for use as a component of adjuvant therapy in women with evidence of axillary lymph node involvement following resection of primary breast cancer
- For the liposomal formulation, doxorubicin is indicated for the treatment of ovarian cancer that has progressed or recurred after platinum-based chemotherapy, AIDS-Related Kaposi's Sarcoma after the failure of prior systemic chemotherapy or intolerance to such therapy, and multiple myeloma in combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy
Product Snapshot
- Doxorubicin is an injectable small-molecule cytotoxic API available in conventional and liposomal formulations
- It is used across a wide range of oncology indications including hematologic malignancies, solid tumors, and as a component of adjuvant regimens
- It is approved in the US, Canada, and EU, with some formulations also holding investigational status
Clinical Overview
Doxorubicin (CAS 23214-92-8) is an anthracycline antineoplastic agent used for a broad range of hematologic and solid tumors. It is indicated for acute leukemias, Hodgkin and non-Hodgkin lymphomas, metastatic breast cancer, metastatic pediatric malignancies such as Wilms’ tumor and neuroblastoma, and metastatic sarcomas and carcinomas of the ovary, bladder, thyroid, stomach, and lung. It is also used as part of adjuvant therapy in breast cancer with axillary lymph node involvement. Liposomal formulations are applied in recurrent or platinum‑resistant ovarian cancer, AIDS‑related Kaposi’s sarcoma after inadequate prior therapy, and in combination regimens for multiple myeloma.
Doxorubicin is a cytotoxic, cell‑cycle non‑specific agent that intercalates into DNA. Intercalation introduces torsional strain, destabilizes nucleosome architecture, and disrupts transcriptional and replicative processes. The stabilized doxorubicin‑DNA complex inhibits topoisomerase II by preventing relegation of enzyme‑induced DNA breaks, producing apoptosis. Additional cytotoxicity arises from the formation of semiquinone radicals via microsomal NADPH‑cytochrome P450 reductase. Reoxidation of these intermediates generates reactive oxygen species capable of inducing lipid peroxidation, membrane damage, and further DNA injury. Limited antioxidant capacity in tumor and myocardial tissue contributes to both antitumor efficacy and characteristic cardiotoxicity.
Absorption is not applicable to intravenous dosing. Metabolism includes enzymatic reduction to reactive intermediates, with reactive oxygen species contributing to overall toxicity. The drug interacts with multiple transporters and metabolic pathways, including substrates or inhibitors of CYP3A, CYP2D6, and P‑glycoprotein, which can influence exposure and safety, particularly for agents with a narrow therapeutic index.
Major toxicities include cumulative dose‑related cardiomyopathy, myelosuppression, mucosal injury, and photosensitivity. Cardiac risk limits lifetime cumulative dosing and requires careful patient selection and monitoring.
Common usage contexts include non‑liposomal injectable products and liposomal formulations such as pegylated liposomal doxorubicin.
For API sourcing, ensure compliance with regional pharmacopoeial specifications, control of anthracycline‑related impurities, validated potency assays, and robust stability data due to sensitivity of the tetracenequinone structure to degradation.
Doxorubicin is a cytotoxic, cell‑cycle non‑specific agent that intercalates into DNA. Intercalation introduces torsional strain, destabilizes nucleosome architecture, and disrupts transcriptional and replicative processes. The stabilized doxorubicin‑DNA complex inhibits topoisomerase II by preventing relegation of enzyme‑induced DNA breaks, producing apoptosis. Additional cytotoxicity arises from the formation of semiquinone radicals via microsomal NADPH‑cytochrome P450 reductase. Reoxidation of these intermediates generates reactive oxygen species capable of inducing lipid peroxidation, membrane damage, and further DNA injury. Limited antioxidant capacity in tumor and myocardial tissue contributes to both antitumor efficacy and characteristic cardiotoxicity.
Absorption is not applicable to intravenous dosing. Metabolism includes enzymatic reduction to reactive intermediates, with reactive oxygen species contributing to overall toxicity. The drug interacts with multiple transporters and metabolic pathways, including substrates or inhibitors of CYP3A, CYP2D6, and P‑glycoprotein, which can influence exposure and safety, particularly for agents with a narrow therapeutic index.
Major toxicities include cumulative dose‑related cardiomyopathy, myelosuppression, mucosal injury, and photosensitivity. Cardiac risk limits lifetime cumulative dosing and requires careful patient selection and monitoring.
Common usage contexts include non‑liposomal injectable products and liposomal formulations such as pegylated liposomal doxorubicin.
For API sourcing, ensure compliance with regional pharmacopoeial specifications, control of anthracycline‑related impurities, validated potency assays, and robust stability data due to sensitivity of the tetracenequinone structure to degradation.
Identification & chemistry
| Generic name | Doxorubicin |
|---|---|
| Molecule type | Small molecule |
| CAS | 23214-92-8 |
| UNII | 80168379AG |
| DrugBank ID | DB00997 |
Pharmacology
| Summary | Doxorubicin is an anthracycline cytotoxic agent that intercalates into DNA and inhibits topoisomerase II, disrupting replication and transcription and promoting apoptosis. It also generates reactive oxygen species through redox cycling, contributing to additional DNA and membrane damage. These combined mechanisms underlie its activity against a broad range of malignant cells. |
|---|---|
| Mechanism of action | Generally, doxorubicin is thought to exert its antineoplastic activity through 2 primary mechanisms: intercalation into DNA and disrupt topoisomerase-mediated repairs and free radicals-mediated cellular damages. Doxorubicin can intercalate into DNA through the anthraquinone ring, which stabilizes the complex by forming hydrogen bonds with DNA bases.Intercalation of doxorubicin can introduce torsional stress into the polynucleotide structure, thus destabilizing nucleosome structures and leading to nucleosome eviction and replacement.Additionally, the doxorubicin-DNA complex can interfere with topoisomerase II enzyme activity by preventing relegation of topoisomerase-mediated DNA breaks, thus inhibiting replication and transcription and inducing apoptosis. Moreover, doxorubicin can be metabolized by microsomal NADPH-cytochrome P-450 reductase into a semiquinone radical, which can be reoxidized in the presence of oxygen to form oxygen radicals.Reactive oxygen species have been known to cause cellular damage through various mechanisms, including lipid peroxidation and membrane damage, DNA damage, oxidative stress, and apoptosis.Although free radicals generated from this pathway can be deactivated by catalase and superoxide dismutase, tumor and myocardial cells tend to lack these enzymes, thus explaining doxorubicin's effectiveness against cancer cells and tendency to cause cardiotoxicity. |
| Pharmacodynamics | Doxorubicin is a cytotoxic, cell-cycle non-specific anthracycline antibiotic.It is generally thought to exert its antitumor effect by destabilizing DNA structures through intercalation, thus introducing DNA strand breakages and damages.Not only does it alter the transcriptomes of the cells, failure in repairing DNA structures can also initiate the apoptotic pathways.Additionally, doxorubicin intercalation can also interfere with vital enzyme activity, such as topoisomerase II, DNA polymerase, and RNA polymerase, leading to cell cycle arrests.Finally, doxorubicin can also generate cytotoxic reactive oxygen species to exert cellular damages. |
Targets
| Target | Organism | Actions |
|---|---|---|
| DNA topoisomerase 2-alpha | Humans | inhibitor |
| DNA | Humans | intercalation |
| Nucleolar and coiled-body phosphoprotein 1 | Humans |
ADME / PK
| Absorption | Following a 10 mg/m<sup>2</sup> administration of liposomal doxorubicin in patients with AIDS-related Kaposi's Sarcoma, the C<sub>max</sub> and AUC values were calculated to be 4.12 ± 0.215 μg/mL and 277 ± 32.9 μg/mL•h respectively. |
|---|---|
| Half-life | The terminal half-life of doxorubicin ranges from 20 hours to 48 hours.The distribution half-life of doxorubicin is approximately 5 minutes.For the liposomal formulation, the first-phase and second-phase half-lives were calculated to be 4.7 ± 1.1 and 52.3 ± 5.6 hours respectively for a 10 mg/m<sup>2</sup> of doxorubicin in patients with AIDS-Related Kaposi’s Sarcoma. |
| Protein binding | The binding of doxorubicin and its major metabolite, doxorubicinol, to plasma proteins is 75% and is independent of plasma concentration of doxorubicin up to 1.1 µg/mL. Doxorubicin does not cross the blood-brain barrier.Plasma protein binding of doxorubicin hydrochloride liposome injection has not been determined. |
| Metabolism | Doxorubicin is capable of undergoing 3 metabolic routes: one-electron reduction, two-electron reduction, and deglycosidation. However, approximately half of the dose is eliminated from the body unchanged. The two-electron reduction is the major metabolic pathway of doxorubicin.In this pathway, doxorubicin is reduced to doxorubicinol, a secondary alcohol, by various enzymes, including Alcohol dehydrogenase [NADP(+)], Carbonyl reductase [NADPH] 1, Carbonyl reductase [NADPH] 3, and Aldo-keto reductase family 1 member C3. The one-electron reduction is facilitated by several oxidoreductase, both cytosolic and mitochondrial, to form a doxirubicin-semiquinone radical.These enzymes include mitochondrial and cystolic NADPH dehydrogenates, xanthine oxidase, and nitric oxide synthases.This semiquinone metabolite can be re-oxidized to doxorubicin, although with the concurrent formation of reactive oxygen species (ROS) and hydrogen peroxide.It is the ROS generating through this pathway that contributes most to the doxorubicin-related adverse effects, particularly cardiotoxicity, rather than through doxorubicin semiquinone formation. Deglycosidation is a minor metabolic pathway, since it only accounts for 1 to 2% of doxorubicin metabolism.Under the catalysis of cytoplasmic NADPH quinone dehydrogenase, xanthine oxidase, NADPH-cytochrome P450 reductase, doxorubicin can either be reduced to doxorubicin deoxyaglycone or hydrolyzed to doxorubicin hydroxyaglycone. |
| Route of elimination | Approximately 40% of the dose appears in the bile in 5 days, while only 5% to 12% of the drug and its metabolites appear in the urine during the same time period. In urine, <3% of the dose was recovered as doxorubicinol over 7 days. |
| Volume of distribution | The steady-state distribution volume of doxorubicin ranges from 809 L/m<sup>2</sup> to 1214 L/m<sup>2</sup>. |
| Clearance | The plasma clearance of doxorubicin ranges from 324 mL/min/m2 to 809 mL/min/m<sup>2</sup> by metabolism and biliary excretion.Sexual differences in doxorubicin were also observed, with men having a higher clearance compared to women (1088 mL/min/m<sup>2</sup> versus 433 mL/min/m<sup>2</sup>).Following the administration of doses ranging from 10 mg/m2 to 75 mg/m<sup>2</sup> of doxorubicin hydrochloride, the plasma clearance was estimated to be 1540 mL/min/m<sup>2</sup> in children greater than 2 years of age and 813 mL/min/m<sup>2</sup> in infants younger than 2 years of age. |
Formulation & handling
- Doxorubicin is formulated exclusively for parenteral use, commonly as IV solutions or reconstituted lyophilized powders, with liposomal variants used to modify pharmacokinetics.
- The small‑molecule anthracycline is water soluble and chemically sensitive to light and oxidation, requiring protected handling and controlled reconstitution conditions.
- Liposomal and suspension forms require attention to particle integrity and avoidance of mechanical stress during preparation and administration.
Regulatory status
| Lifecycle | Patents covering the API expired in the United States in 2009 and in Canada by 2013, and no active protections are indicated for the EU. With all listed markets now effectively off‑patent, the product is in a mature lifecycle stage with established generic competition. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Doxorubicin originated from a small set of innovator companies, with the originator brand (Adriamycin) now supplemented by a broad network of manufacturers and packagers supporting global supply. Branded and generic products are well established across the US, Canada, and the EU. Key patents expired between 2009 and 2013, indicating that generic competition is long-standing and multiple suppliers are active in the market. |
|---|
Safety
| Toxicity | Doxorubicin hydrochloride treatment can increase the risk of secondary malignancies based on postmarketing reports. Doxorubicin hydrochloride was mutagenic in the in vitro Ames assay, and clastogenic in multiple in vitro assays (CHO cell, V79 hamster cell, human lymphoblast, and SCE assays) and the in vivo mouse micronucleus assay. Doxorubicin hydrochloride decreased fertility in female rats at doses of 0.05 and 0.2 mg/kg/day (approximately 0.005 and 0.02 times the recommended human dose, based on body surface area).In females of reproductive potential, Doxorubicin hydrochloride may cause infertility and result in amenorrhea. Premature menopause can occur. Recovery of menses and ovulation is related to age at treatment. A single intravenous dose of 0.1 mg/kg doxorubicin hydrochloride (approximately 0.01 times the recommended human dose based on body surface area) was toxic to male reproductive organs in animal studies, producing testicular atrophy, diffuse degeneration of the seminiferous tubules, and oligospermia/hypospermia in rats. Doxorubicin hydrochloride induces DNA damage in rabbit spermatozoa and dominant lethal mutations in mice. Based on findings in animals and its mechanism of action, Doxorubicin Hydrochloride Injection/for Injection can cause fetal harm when administered to a pregnant woman; avoid the use of Doxorubicin Hydrochloride Injection/for Injection during the 1st trimester. Available human data do not establish the presence or absence of major birth defects and miscarriage related to the use of doxorubicin hydrochloride during the 2nd and 3rd trimesters. Doxorubicin hydrochloride was teratogenic and embryotoxic in rats and embryotoxic in rabbits when administered during organogenesis at doses approximately 0.07 times (based on body surface area) the recommended human dose of 60 mg/m2. Advise pregnant women of the potential risk to a fetus. Based on postmarketing reports, pediatric patients treated with doxorubicin hydrochloride are at risk for developing late cardiovascular dysfunction. Risk factors include young age at treatment (especially < 5 years), high cumulative doses and receipt of combined modality therapy. Long-term periodic cardiovascular monitoring is recommended for all pediatric patients who have received doxorubicin hydrochloride. Doxorubicin hydrochloride, as a component of intensive chemotherapy regimens administered to pediatric patients, may contribute to prepubertal growth failure and may also contribute to gonadal impairment, which is usually temporary. |
|---|
High Level Warnings:
- Genotoxic and clastogenic profile demonstrated across multiple in vitro and in vivo systems, with postmarketing reports linking exposure to secondary malignancies
- Reproductive toxicity observed at low exposures in animal models, including ovarian and testicular effects, germ‑cell DNA damage, and embryo–fetal toxicity during organogenesis
- Pediatric exposure associated with late-onset cardiovascular dysfunction in postmarketing data, with additional contributions to growth and gonadal developmental impairment when used in intensive regimens
US Drug Master File (USDMF)
A US Drug Master File (USDMF) is a confidential document submitted to the U.S. Food and Drug Administration (FDA) that provides detailed information about the manufacturing process of an Active Pharmaceutical Ingredient (API) or a finished pharmaceutical product. This document includes comprehensive details such as chemical properties, manufacturing facilities, production processes, packaging specifications, storage conditions, and more.
The USDMF ensures that proprietary information remains protected while allowing the FDA to review the data as part of drug approval processes. Unlike other types of DMFs used in different regions, the USDMF is specifically designed to meet the regulatory requirements set by the FDA, ensuring compliance with U.S. standards.
Doxorubicin 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.
Doxorubicin (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.
Doxorubicin API manufacturers & distributors
Compare qualified Doxorubicin API suppliers worldwide. We currently have 12 companies offering Doxorubicin 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 | CoA, WC | 3 products |
| Intas Pharma | Producer | United Kingdom | India | CEP, CoA, FDA, GMP | 30 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Meiji Seika | Producer | Japan | Japan | CEP, CoA, FDA, JDMF, USDMF | 5 products |
| Microbiopharm Japan | Producer | Japan | Japan | CEP, CoA, FDA, JDMF, USDMF | 5 products |
| Natco Pharma | Producer | India | India | CoA, WC | 40 products |
| Pharmacia & Upjohn | Producer | United States | United States | CoA, USDMF | 30 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, USDMF, WC | 757 products |
| Sterling Biotech | Producer | India | India | CEP, CoA, GMP, USDMF, WC | 5 products |
| Synbias Pharma | Producer | Switzerland | Switzerland | CoA, USDMF | 7 products |
| Zhejiang Hisun Pharma | Producer | China | China | CEP, CoA, GMP, JDMF, USDMF, WC | 69 products |
When sending a request, specify which Doxorubicin 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 Doxorubicin 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 Doxorubicin API
Sourcing
What matters most when sourcing GMP-grade Doxorubicin?
Ensure the manufacturer complies with GMP standards recognized in the US, Canada, and the EU and can provide complete regulatory documentation. Verify that the supplier has an established quality system suitable for an injectable oncology API. Given the broad generic competition, assess supply reliability and consistency across manufacturers and packagers.
Which documents are typically required when sourcing Doxorubicin API?
Request the core API documentation set: CoA (12 companies), USDMF (9 companies), CEP (8 companies), WC (6 companies), GMP (6 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Doxorubicin API?
Known or reported manufacturers for Doxorubicin: Sinoway industrial Co.,Ltd, Apollo Healthcare Resources (Singapore), LGM Pharma. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Doxorubicin API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Doxorubicin manufacturers?
Audit reports may be requested for Doxorubicin: 4 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Doxorubicin API on Pharmaoffer?
Reported supplier count for Doxorubicin: 12 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Doxorubicin API?
Production countries reported for Doxorubicin: China (3 producers), India (3 producers), Japan (2 producers). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Doxorubicin usually hold?
Common certifications for Doxorubicin suppliers: CoA (12 companies), USDMF (9 companies), CEP (8 companies), WC (6 companies), GMP (6 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Doxorubicin (CAS 23214-92-8) used for?
Doxorubicin is an anthracycline antineoplastic agent used to treat a wide range of hematologic and solid tumors. It is indicated for acute leukemias, Hodgkin and non‑Hodgkin lymphomas, metastatic breast cancer, pediatric tumors such as Wilms’ tumor and neuroblastoma, and metastatic sarcomas and various carcinomas. It is also used as adjuvant therapy in breast cancer with axillary lymph node involvement. Liposomal formulations are applied in recurrent or platinum‑resistant ovarian cancer, AIDS‑related Kaposi’s sarcoma after inadequate prior therapy, and in combination regimens for multiple myeloma.
Which therapeutic class does Doxorubicin fall into?
Doxorubicin belongs to the following therapeutic categories: Anthracycline Topoisomerase Inhibitor, Anthracyclines, Anthracyclines and Related Substances, Antibiotics, Antineoplastic, Antineoplastic Agents. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Doxorubicin mainly prescribed for?
The primary indications for Doxorubicin: Doxorubicin is indicated for the treatment of neoplastic conditions like acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin and non-Hodgkin lymphoma, metastatic breast cancer, metastatic Wilms’ tumor, metastatic neuroblastoma, metastatic soft tissue and bone sarcomas, metastatic ovarian carcinoma, metastatic transitional cell bladder carcinoma, metastatic thyroid carcinoma, metastatic gastric carcinoma, and metastatic bronchogenic carcinoma, Doxorubicin is also indicated for use as a component of adjuvant therapy in women with evidence of axillary lymph node involvement following resection of primary breast cancer, For the liposomal formulation, Doxorubicin is indicated for the treatment of ovarian cancer that has progressed or recurred after platinum-based chemotherapy, AIDS-Related Kaposi's Sarcoma after the failure of prior systemic chemotherapy or intolerance to such therapy, and multiple myeloma in combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Doxorubicin work?
Generally, Doxorubicin is thought to exert its antineoplastic activity through 2 primary mechanisms: intercalation into DNA and disrupt topoisomerase-mediated repairs and free radicals-mediated cellular damages.
Doxorubicin can intercalate into DNA through the anthraquinone ring, which stabilizes the complex by forming hydrogen bonds with DNA bases.Intercalation of Doxorubicin can introduce torsional stress into the polynucleotide structure, thus destabilizing nucleosome structures and leading to nucleosome eviction and replacement.Additionally, the Doxorubicin-DNA complex can interfere with topoisomerase II enzyme activity by preventing relegation of topoisomerase-mediated DNA breaks, thus inhibiting replication and transcription and inducing apoptosis.
Moreover, Doxorubicin can be metabolized by microsomal NADPH-cytochrome P-450 reductase into a semiquinone radical, which can be reoxidized in the presence of oxygen to form oxygen radicals.Reactive oxygen species have been known to cause cellular damage through various mechanisms, including lipid peroxidation and membrane damage, DNA damage, oxidative stress, and apoptosis.Although free radicals generated from this pathway can be deactivated by catalase and superoxide dismutase, tumor and myocardial cells tend to lack these enzymes, thus explaining Doxorubicin's effectiveness against cancer cells and tendency to cause cardiotoxicity.
What should someone know about the safety or toxicity profile of Doxorubicin?
Doxorubicin has a well‑defined genotoxic and clastogenic profile and has been linked to secondary malignancies in postmarketing experience. It produces dose‑related cardiomyopathy, with pediatric patients at particular risk for late‑onset cardiovascular dysfunction. Reproductive and developmental toxicity occurs at low exposures in animal models, including germ‑cell DNA damage and embryo–fetal effects. Other major toxicities include myelosuppression, mucosal injury, and photosensitivity, and lifetime cumulative dosing limits are required to mitigate cardiac risk.
What are important formulation and handling considerations for Doxorubicin as an API?
Doxorubicin is formulated for parenteral administration, typically as IV solutions or reconstituted lyophilized powders, and must be protected from light and oxidative conditions due to chemical sensitivity. Reconstitution and dilution should be performed under controlled conditions to maintain stability. Liposomal and suspension formulations require care to preserve particle integrity, including avoiding excessive agitation or mechanical stress.
Is Doxorubicin a small molecule?
Doxorubicin is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Doxorubicin?
Doxorubicin is not formulated for oral use; all available formulations are parenteral. Its known stability concerns relate to sensitivity to light and oxidation, requiring protection from light and controlled handling. These same chemical liabilities would be relevant to any oral form, but no oral products are used clinically.
Regulatory
Where is Doxorubicin approved or in use globally?
Doxorubicin is reported as approved in the following major regions: US, Canada, EU. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Doxorubicin right now?
Doxorubicin is an established chemotherapeutic agent with regulatory approval in the US, Canada, and the EU. Its primary compound patents have long expired, and the product is widely available in generic forms. Current protection, where applicable, is limited to certain formulations or delivery systems rather than the active ingredient itself.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Doxorubicin procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Doxorubicin. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Doxorubicin included in the PRO Data Insights coverage?
PRO Data Insights coverage for Doxorubicin: 1119 verified transactions across 275 suppliers and 170 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Doxorubicin?
Market report availability for Doxorubicin: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
