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Fludarabine | CAS No: 21679-14-1 | GMP-certified suppliers
A medication that treats adult B-cell chronic lymphocytic leukemia resistant to standard alkylating-agent regimens by targeting malignant lymphocyte proliferation with immunosuppressive and antineoplastic effects.
Therapeutic categories
Primary indications
- For the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen
Product Snapshot
- Fludarabine is available as oral tablets and injectable formulations including lyophilized powder for solution and concentrates
- It is indicated for the treatment of adult patients with B-cell chronic lymphocytic leukemia who have failed prior alkylating-agent regimens
- The product is approved for use in key regulatory markets including the United States and Canada
Clinical Overview
Pharmacologically, fludarabine acts as an antimetabolite. After administration, fludarabine phosphate is rapidly dephosphorylated to 2-fluoro-ara-A, which is then intracellularly phosphorylated by deoxycytidine kinase into its active triphosphate form, 2-fluoro-ara-ATP. This active metabolite inhibits several critical enzymes involved in DNA synthesis, including DNA polymerase alpha, ribonucleotide reductase, and DNA primase. The resultant interference with DNA replication leads to the targeted killing of malignant lymphocytes. While the predominant mechanism involves DNA synthesis inhibition, the full scope of its actions may involve multiple interconnected pathways.
Pharmacokinetic parameters such as absorption, distribution, metabolism, and excretion influence fludarabine’s clinical use, with intracellular activation being critical for efficacy. The drug exhibits myelosuppressive effects, notably causing neutropenia and anemia, which require careful monitoring. Toxicity considerations include potential immunosuppression and possible neurotoxicity at high doses or prolonged use. Due to its narrow therapeutic index, dosage adjustments and vigilant patient management are essential to minimize adverse effects.
Fludarabine’s categorization encompasses adenine nucleotides, antimetabolites, antineoplastic agents, immunosuppressive agents, and myelosuppressive agents. It is recognized as a narrow therapeutic index drug with significant toxicological profiles that must be managed judiciously in clinical practice.
For API procurement, sourcing high-purity fludarabine is critical to ensure consistent pharmacological activity and safety. Manufacturers should comply with relevant pharmacopeial standards and regulatory guidelines, with rigorous quality control to verify identity, potency, and absence of impurities. Proper storage and handling are also important to maintain stability and integrity of the active pharmaceutical ingredient.
Identification & chemistry
| Generic name | Fludarabine |
|---|---|
| Molecule type | Small molecule |
| CAS | 21679-14-1 |
| UNII | P2K93U8740 |
| DrugBank ID | DB01073 |
Pharmacology
| Summary | Fludarabine phosphate is a nucleoside analog prodrug that is intracellularly converted to its active triphosphate form, inhibiting key enzymes involved in DNA synthesis, including DNA polymerase alpha, ribonucleotide reductase, and DNA primase. By disrupting DNA replication, it exerts cytotoxic effects on malignant B-cells. It is primarily indicated for treating adult patients with B-cell chronic lymphocytic leukemia refractory to prior alkylating-agent therapies. |
|---|---|
| Mechanism of action | Fludarabine phosphate is rapidly dephosphorylated to 2-fluoro-ara-A and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2-fluoro-ara-ATP. This metabolite appears to act by inhibiting DNA polymerase alpha, ribonucleotide reductase and DNA primase, thus inhibiting DNA synthesis. The mechanism of action of this antimetabolite is not completely characterized and may be multi-faceted. |
| Pharmacodynamics | Fludarabine is a chemotherapy drug used in the treatment of chronic lymphocytic leukemia. It acts at DNA polymerase alpha, ribonucleotide reductase and DNA primase, results in the inhibition of DNA synthesis, and destroys the cancer cells. |
Targets
| Target | Organism | Actions |
|---|---|---|
| DNA | Humans | incorporation into and destabilization |
| Deoxycytidine kinase | Humans | agonist |
| DNA polymerase alpha catalytic subunit | Humans | inhibitor |
ADME / PK
| Absorption | Bioavailability is 55% following oral administration. |
|---|---|
| Half-life | 20 hours |
| Protein binding | 19-29% |
| Clearance | * 117-145 mL/min [patients with B-cell CLL receiving IV administration of a single dose of 40 mg/m^2. |
Formulation & handling
- Fludarabine is a small molecule purine nucleoside available for both oral and intravenous administration, including lyophilized powder for solution formulations.
- The API exhibits moderate water solubility and a negative LogP, indicating hydrophilic properties relevant for formulation in aqueous media.
- Food intake may delay absorption of the oral form but does not significantly impact overall bioavailability, simplifying dosing considerations.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient is marketed in the United States and Canada, with primary patents having expired between 2018 and 2022, indicating that the product is in a mature market phase with potential generic competition. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Fludarabine is supplied by multiple manufacturers, including both originator and generic companies, with branded products primarily present in the US and Canadian markets. The patents listed indicate expiration dates in late 2018 and late 2022, suggesting that generic competition is currently established or emerging. The supply landscape includes a broad base of packagers, reflecting a competitive environment for sourcing this API. |
|---|
Fludarabine is a type of Antineoplastics
Antineoplastics are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) primarily used in the treatment of cancer. These powerful substances inhibit or destroy the growth of cancer cells, thus impeding the progression of malignancies.
Antineoplastics exert their therapeutic effects through various mechanisms. Some APIs interfere with DNA replication, inhibiting the division and proliferation of cancer cells. Others target specific proteins or enzymes involved in tumor growth, effectively blocking their function. Additionally, certain antineoplastic agents induce programmed cell death, known as apoptosis, in cancer cells.
These APIs find application in a wide range of cancer treatments, including chemotherapy, targeted therapy, immunotherapy, and hormone therapy. They are often administered in combination with other drugs to optimize therapeutic outcomes and minimize drug resistance.
Antineoplastics are typically synthesized through complex chemical processes, ensuring high purity and potency. Stringent quality control measures are implemented throughout manufacturing to meet regulatory standards and ensure patient safety.
Although antineoplastics offer significant benefits in treating cancer, they can also cause adverse effects due to their cytotoxic nature. Common side effects include bone marrow suppression, gastrointestinal disturbances, hair loss, and immune system suppression. Close monitoring and supportive care are essential to manage these side effects effectively.
In conclusion, antineoplastics are a vital category of pharmaceutical APIs used in the treatment of cancer. Through their diverse mechanisms of action, these compounds play a critical role in combating malignancies and improving patient outcomes.
Fludarabine API manufacturers & distributors
Compare qualified Fludarabine API suppliers worldwide. We currently have 6 companies offering Fludarabine API, with manufacturing taking place in 3 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 |
|---|---|---|---|---|---|
| Euticals | Producer | Italy | Unknown | CEP, CoA, FDA, GMP | 48 products |
| Hubei Biocause | Producer | China | China | CEP, CoA, FDA, USDMF | 12 products |
| Reliable Biopharm | Producer | United States | United States | CoA, USDMF | 11 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, MSDS, USDMF | 762 products |
| Tianjin Pharmacn Medical ... | Producer | China | China | BSE/TSE, CoA, GMP, MSDS | 66 products |
| Zhejiang Hisun Pharma | Producer | China | China | CoA, USDMF, WC | 69 products |
When sending a request, specify which Fludarabine 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 Fludarabine 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.
