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Paclitaxel | CAS No: 33069-62-4 | GMP-certified suppliers
A medication that treats ovarian, breast, and lung cancers as well as Kaposi’s sarcoma, supporting reliable oncology supply needs for diverse global treatment programs.
Therapeutic categories
Primary indications
- Used in the treatment of Kaposi's sarcoma and cancer of the lung, ovarian, and breast
- Abraxane® is specfically indicated for the treatment of metastatic breast cancer and locally advanced or metastatic non-small cell lung cancer
Product Snapshot
- Paclitaxel is an injectable small‑molecule cytotoxic API supplied mainly as solutions or lyophilized powders for reconstitution
- It is used across oncology portfolios for Kaposi’s sarcoma and lung, ovarian, and breast cancers, including solvent-free nanoparticle albumin-bound formulations
- It is approved in major regulated markets including the US, EU, and Canada
Clinical Overview
Paclitaxel exerts cytotoxic activity by promoting microtubule assembly and preventing their depolymerization. Binding occurs at the beta‑tubulin subunit, locking tubulin within stabilized microtubules and suppressing dynamic instability. This interruption of microtubule remodeling impairs mitotic spindle formation and disrupts intracellular transport. The drug also induces aberrant microtubule bundles and multipolar asters during mitosis. Further evidence supports paclitaxel‑mediated apoptosis through interaction with Bcl‑2, contributing to programmed cell death in susceptible tumor cells.
Absorption is not relevant due to intravenous administration. Distribution is extensive, with high tissue binding attributed to the lipophilic taxane structure. Metabolism primarily involves CYP2C8 and CYP3A isoenzymes, and paclitaxel is a substrate for multiple transporters including P‑glycoprotein and OATP1B3. Elimination occurs mainly through hepatic pathways, and pharmacokinetic variability may be significant in the presence of hepatic impairment or interacting drugs.
Safety considerations include dose‑dependent myelosuppression, peripheral neuropathy, and hypersensitivity reactions associated with certain excipients in conventional formulations. Cardiotoxicity, hypotension, and neurotoxicity have also been reported. The drug’s classification as a narrow therapeutic index agent underscores the importance of controlled dosing, monitoring, and careful management of metabolic and transporter‑mediated interactions.
Paclitaxel is marketed under established global brands such as Taxol and Abraxane, with widespread use in oncology protocols. For API procurement, sourcing should prioritize material from manufacturers with demonstrated control of stereochemical integrity, impurity profiles, and solvent residues, along with full compliance to ICH and pharmacopeial specifications to support regulatory submissions and global supply needs.
Identification & chemistry
| Generic name | Paclitaxel |
|---|---|
| Molecule type | Small molecule |
| CAS | 33069-62-4 |
| UNII | P88XT4IS4D |
| DrugBank ID | DB01229 |
Pharmacology
| Summary | Paclitaxel is an antineoplastic agent that stabilizes microtubules by binding the beta‑tubulin subunit, preventing their normal depolymerization and disrupting essential cellular dynamics required for mitosis. This microtubule stabilization leads to mitotic arrest and contributes to apoptosis, including through interactions with proteins such as Bcl‑2. Its activity involves targets including tubulin, microtubule‑associated proteins, and apoptosis‑regulating pathways. |
|---|---|
| Mechanism of action | Paclitaxel interferes with the normal function of microtubule growth. Whereas drugs like colchicine cause the depolymerization of microtubules in vivo, paclitaxel arrests their function by having the opposite effect; it hyper-stabilizes their structure. This destroys the cell's ability to use its cytoskeleton in a flexible manner. Specifically, paclitaxel binds to the β subunit of tubulin. Tubulin is the "building block" of mictotubules, and the binding of paclitaxel locks these building blocks in place. The resulting microtubule/paclitaxel complex does not have the ability to disassemble. This adversely affects cell function because the shortening and lengthening of microtubules (termed dynamic instability) is necessary for their function as a transportation highway for the cell. Chromosomes, for example, rely upon this property of microtubules during mitosis. Further research has indicated that paclitaxel induces programmed cell death (apoptosis) in cancer cells by binding to an apoptosis stopping protein called Bcl-2 (B-cell leukemia 2) and thus arresting its function. |
| Pharmacodynamics | Paclitaxel is a taxoid antineoplastic agent indicated as first-line and subsequent therapy for the treatment of advanced carcinoma of the ovary, and other various cancers including breast cancer. Paclitaxel is a novel antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability results in the inhibition of the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions. In addition, paclitaxel induces abnormal arrays or "bundles" of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Tubulin beta-1 chain | Humans | inhibitor |
| Apoptosis regulator Bcl-2 | Humans | inhibitor |
| Microtubule-associated protein 4 | Humans |
ADME / PK
| Absorption | When a 24 hour infusion of 135 mg/m^2 is given to ovarian cancer patients, the maximum plasma concentration (Cmax) is 195 ng/mL, while the AUC is 6300 ng•h/mL. |
|---|---|
| Half-life | When a 24 hour infusion of 135 mg/m^2 is given to ovarian cancer patients, the elimination half=life is 52.7 hours. |
| Protein binding | 89%-98% bound to plasma protein. The presence of cimetidine, ranitidine, dexamethasone, or diphenhydramine did not affect protein binding of paclitaxel. |
| Metabolism | Hepatic. In vitro studies with human liver microsomes and tissue slices showed that paclitaxel was metabolized primarily to 6a-hydrox-ypaclitaxel by the cytochrome P450 isozyme CYP2C8; and to two minor metabolites, 3’-p-hydroxypaclitaxel and 6a, 3’-p-dihydroxypaclitaxel, by CYP3A4. |
| Route of elimination | In 5 patients administered a 225 or 250 mg/m2 dose of radiolabeled paclitaxel as a 3-hour infusion, a mean of 71% of the radioactivity was excreted in the feces in 120 hours, and 14% was recovered in the urine. |
| Volume of distribution | * 227 to 688 L/m^2 [apparent volume of distribution at steady-state, 24 hour infusion] |
| Clearance | * 21.7 L/h/m2 [Dose 135 mg/m2, infusion duration 24 h] * 23.8 L/h/m2 [Dose 175 mg/m2, infusion duration 24 h] * 7 L/h/m2 [Dose 135 mg/m2, infusion duration 3 h] * 12.2 L/h/m2 [Dose 175 mg/m2, infusion duration 3 h] |
Formulation & handling
- Paclitaxel is a poorly water‑soluble small molecule administered parenterally, typically formulated as concentrated IV solutions or reconstituted lyophilized powders using solubilizing excipients.
- Formulation work must account for its extreme hydrophobicity and sensitivity to surfactant/solvent choice, with attention to precipitation risk upon dilution into infusion media.
- Handling considerations include protection from excessive light and careful control of container–closure materials due to adsorption and compatibility issues with common plastics.
Regulatory status
| Lifecycle | Most core U.S. and Canadian patents for the API expired between 2013 and 2014, with one remaining U.S. patent extending protection to 2024, placing the product in a late‑lifecycle stage. Across the US, EU, and Canada, the market is largely mature with broad potential for generic competition. |
|---|
| Markets | US, EU, Canada |
|---|
Supply Chain
| Supply chain summary | Paclitaxel is supplied by a large number of manufacturers and packagers, with the original branded products introduced by originator companies now complemented by extensive generic production. Branded formulations such as those marketed in the US, EU, and Canada remain available, but most core substance and formulation patents have expired, with only a later‑filed patent extending to 2024. As a result, broad global generic competition is already established. |
|---|
Safety
| Toxicity | Rat (ipr) LD<sub>50</sub>=32530 µg/kg. Symptoms of overdose include bone marrow suppression, peripheral neurotoxicity, and mucositis. Overdoses in pediatric patients may be associated with acute ethanol toxicity. |
|---|
- High-dose exposure produces bone marrow suppression, peripheral neurotoxicity, and mucositis
- LD50 in rats (intraperitoneal) is 32
- 53 mg/kg, indicating moderate acute toxicity
Paclitaxel is a type of Taxanes
Taxanes are a vital subcategory of pharmaceutical APIs (Active Pharmaceutical Ingredients) widely used in the treatment of various types of cancers. These organic compounds are derived from plants, with the most notable source being the Pacific yew tree (Taxus brevifolia). Taxanes exhibit potent anticancer properties, making them an essential component of many chemotherapy regimens.
One of the most well-known taxanes is paclitaxel, which acts by inhibiting cell division and promoting cell death in cancer cells. Paclitaxel is employed in the treatment of breast, lung, ovarian, and other types of cancers. Another taxane, docetaxel, shares similar mechanisms of action and is commonly used in the management of breast, prostate, and lung cancers.
The isolation and purification of taxanes from natural sources present significant challenges due to their low abundance. Consequently, pharmaceutical companies have developed synthetic methods to produce taxanes, ensuring a stable supply for medical purposes. These synthetic taxanes have shown comparable efficacy to their natural counterparts.
Taxanes are typically administered intravenously, allowing for optimal distribution throughout the body. They are formulated as injectable solutions containing taxane APIs along with other excipients to enhance solubility and stability. The dosage and administration of taxanes are carefully determined by healthcare professionals, taking into account factors such as the patient's condition and the specific cancer being treated.
In conclusion, taxanes are a crucial subcategory of pharmaceutical APIs used in cancer treatment. Their remarkable anticancer properties, derived from natural or synthetic sources, have revolutionized the management of various types of cancers, providing patients with improved therapeutic options.
Paclitaxel (Taxanes), 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.
Paclitaxel API manufacturers & distributors
Compare qualified Paclitaxel API suppliers worldwide. We currently have 29 companies offering Paclitaxel API, with manufacturing taking place in 11 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 |
|---|---|---|---|---|---|
| Adley Formulations | Producer | India | India | CoA, GMP | 14 products |
| Apino Pharma Co., Ltd. | Producer | China | China | CEP, CoA, FDA, MSDS, USDMF | 229 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| AXXO GmbH | Distributor | Germany | World | CoA, GMP, GDP, MSDS, USDMF | 243 products |
| Blue Eyes Biotech Co., Lt... | Producer | United Kingdom | United Kingdom | CoA | 35 products |
| Chongqing Sintaho Pharmac... | Producer | China | China | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, MSDS, USDMF, WC | 42 products |
| Chongqing Taihao | Producer | China | China | CoA, WC | 7 products |
| Corden Pharma | Producer | Germany | United States | CoA, GMP, USDMF | 45 products |
| Eigenmann & Veronelli | Producer | Italy | Italy | CoA, GMP | 6 products |
| Fujian South Pharma | Producer | China | China | CoA, WC | 7 products |
| Hetero Labs | Producer | India | India | CoA, GMP, USDMF, WC | 90 products |
| Hospira Boulder | Producer | United States | United States | CEP, CoA, KDMF | 5 products |
| Indena | Producer | Italy | Unknown | CEP, CoA, GMP, JDMF, KDMF, USDMF | 15 products |
| Intas Pharma | Producer | United Kingdom | United Kingdom | CEP, CoA, FDA, GMP, USDMF | 30 products |
| Jiangsu Yew | Producer | China | China | CoA | 1 products |
| Jiangxi Bioman Pharma Lim... | Producer | China | China | CoA | 15 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Mac Chem Products | Producer | India | India | CoA, GMP, WC | 25 products |
| MSN Labs. | Producer | India | India | CoA, USDMF | 119 products |
| Phyton Biotech | Producer | Canada | Canada | CEP, CoA, FDA, JDMF, KDMF, USDMF | 2 products |
| Polymed Therapeutics | Producer | United States | United States | CEP, CoA, USDMF | 11 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF | 144 products |
| Samyang Bio | Producer | South Korea | South Korea | CEP, CoA, USDMF | 2 products |
| Seripharm S.A.S. | Producer | France | France | CEP, CoA, GMP, JDMF, USDMF | 2 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shanghai Jinhe Bio-Pharma | Producer | China | China | CoA | 12 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF | 757 products |
| Wuhan Calmland | Producer | China | China | CEP, CoA, GMP, USDMF | 3 products |
| Yung Shin Pharmaceutical | Producer | Taiwan | Taiwan | CoA, USDMF | 7 products |
When sending a request, specify which Paclitaxel 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 Paclitaxel 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 Paclitaxel API
Sourcing
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Technical
What is Paclitaxel (CAS 33069-62-4) used for?
Which therapeutic class does Paclitaxel fall into?
What conditions is Paclitaxel mainly prescribed for?
How does Paclitaxel work?
What should someone know about the safety or toxicity profile of Paclitaxel?
What are important formulation and handling considerations for Paclitaxel as an API?
Is Paclitaxel a small molecule?
Are there special stability concerns for oral Paclitaxel?
Regulatory
Where is Paclitaxel approved or in use globally?
Pharmaoffer
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