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Bendamustine | CAS No: 16506-27-7 | GMP-certified suppliers
A medication that treats chronic lymphocytic leukemia and relapsed indolent B-cell non-Hodgkin lymphoma, offering antineoplastic benefits with a narrow therapeutic index requiring careful quality control.
Therapeutic categories
Primary indications
- Bendamustine is indicated for use in the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen
Product Snapshot
- Bendamustine is available as an injectable formulation, including lyophilized powders and solutions for intravenous administration
- It is primarily used for the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL), particularly in cases progressing after rituximab treatment
- The product is approved for use in regulatory markets including the United States and Canada
Clinical Overview
Pharmacologically, bendamustine functions as a bifunctional mechlorethamine derivative with alkylating activity. It forms electrophilic alkyl groups capable of covalently binding to nucleophilic sites on DNA, leading to intra- and inter-strand DNA crosslinks. These crosslinks interfere with DNA replication and transcription, ultimately inducing apoptosis. The agent exhibits cytotoxicity against both dividing and resting (quiescent) cells; however, the exact mechanism of action remains incompletely elucidated.
Key pharmacodynamic observations include the absence of clinically significant prolongation of the QTc interval within the first hour post-infusion, suggesting minimal acute cardiotoxicity related to cardiac repolarization.
Bendamustine’s pharmacokinetic profile involves metabolism through cytochrome P450 CYP1A2 pathways and it is recognized as a substrate for P-glycoprotein. It is categorized among drugs with a narrow therapeutic index, underscoring the need for careful dose management. The compound demonstrates myelosuppressive and immunosuppressive effects, necessitating monitoring of hematologic parameters and patient immune status during treatment.
Safety considerations focus on its toxicological profile typical of alkylating agents, including potential myelosuppression, risk of infections, and secondary malignancies. Its use requires appropriate clinical and laboratory surveillance to manage and mitigate adverse events.
Bendamustine is marketed under various brand names globally and is utilized within oncology protocols addressing relapsed hematologic malignancies. For pharmaceutical sourcing, stringent quality control is essential due to its narrow therapeutic index and complex synthetic profile. Compliance with pharmacopeial standards and verification of impurity profiles are critical to ensure API quality and consistency in clinical applications.
Identification & chemistry
| Generic name | Bendamustine |
|---|---|
| Molecule type | Small molecule |
| CAS | 16506-27-7 |
| UNII | 9266D9P3PQ |
| DrugBank ID | DB06769 |
Pharmacology
| Summary | Bendamustine is an alkylating agent that induces cytotoxicity by forming covalent DNA crosslinks, leading to cell death in both proliferating and quiescent cells. It targets DNA to disrupt replication and transcription processes, contributing to its antineoplastic effects. The drug is primarily used in hematologic malignancies such as chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma. |
|---|---|
| Mechanism of action | Bendamustine is a bifunctional mechlorethamine derivative capable of forming electrophilic alkyl groups that covalently bond to other molecules. Through this function as an alkylating agent, bendamustine causes intra- and inter-strand crosslinks between DNA bases resulting in cell death. It is active against both active and quiescent cells, although the exact mechanism of action is unknown. |
| Pharmacodynamics | No mean changes in QTc interval greater than 20 milliseconds were detected up to one hour post-infusion. |
ADME / PK
| Absorption | Following a single IV dose of bendamustine hydrochloride Cmax typically occurred at the end of infusion. The dose proportionality of bendamustine has not been studied. |
|---|---|
| Half-life | 40 minutes |
| Protein binding | In vitro, the binding of bendamustine to human serum plasma proteins ranged from 94-96% and data suggest that bendamustine is not likely to displace or to be displaced by highly protein-bound drugs. |
| Metabolism | In vitro data indicate that bendamustine is primarily metabolized via hydrolysis to monohydroxy (HP1) and dihydroxy-bendamustine (HP2) metabolites with low cytotoxic activity. Two active minor metabolites, M3 and M4, are primarily formed via CYP1A2. However, concentrations of these metabolites in plasma are 1/10th and 1/100th that of the parent compound, respectively, suggesting that the cytotoxic activity is primarily due to bendamustine. Results of a human mass balance study confirm that bendamustine is extensively metabolized via hydrolytic, oxidative, and conjugative pathways. |
| Route of elimination | Mean recovery of total radioactivity in cancer patients following IV infusion of [14C] bendamustine hydrochloride was approximately 76% of the dose. Approximately 50% of the dose was recovered in the urine and approximately 25% of the dose was recovered in the feces. Urinary excretion was confirmed as a relatively minor pathway of elimination of bendamustine, with approximately 3.3% of the dose recovered in the urine as parent. Less than 1% of the dose was recovered in the urine as M3 and M4, and less than 5% of the dose was recovered in the urine as HP2. |
| Volume of distribution | The mean steady-state volume of distribution (Vss) of bendamustine was approximately 20-25 L. Steady-state volume of distribution for total radioactivity was approximately 50 L, indicating that neither bendamustine nor total radioactivity are extensively distributed into the tissues. |
| Clearance | 700 mL/min |
Formulation & handling
- Bendamustine is administered exclusively via intravenous injection, requiring sterile preparation and administration.
- As a small molecule with low water solubility, formulation often involves lyophilized powder for reconstitution or concentrated injectable solutions.
- Stability considerations include protection from moisture and appropriate storage of lyophilized and solution forms to maintain potency.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient is currently protected by multiple patents in the United States, with expiration dates ranging from July 2026 to March 2030, indicating ongoing patent protection and market exclusivity primarily in the US and Canada. Post-expiration, the API is expected to face generic competition, reflecting a transition toward market maturity. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | The bendamustine supply landscape involves multiple originator products primarily distributed in the US and Canadian markets. The presence of several active patents in the United States extending through 2026 to 2030 indicates ongoing exclusivity, suggesting limited generic competition at this time. Current branded products maintain a significant role in these regions, with no indication of broader market presence outside North America. |
|---|
Safety
| Toxicity | Risk for tumor-lysis syndrome. Discontinue use in the event of severe/progressive skin reactions. Hematologic malignancies of different forms reported. Discontinue use in the case of severe infusion reactions. May cause extravasation. Mild to moderate renal impairment. Mild hepatic impairment. Sepsis (infections) may occur. Avoid use if pregnant. Possibility of anaphylaxis or infusion reactions- severe in rare cases. |
|---|
- Potential for severe infusion-related reactions, including anaphylaxis
- Implement appropriate monitoring and handling protocols
- Risk of tumor lysis syndrome requires careful management during administration
Bendamustine is a type of Alkylating agents
Alkylating agents are a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a significant role in cancer treatment. These compounds possess the ability to attach alkyl groups to the DNA molecule, effectively disrupting its structure and preventing cell replication. This mechanism of action makes alkylating agents potent chemotherapy drugs for various types of cancers.
Alkylating agents are often classified based on their chemical structure, which includes nitrogen mustards, ethylenimines, nitrosoureas, and alkyl sulfonates, among others. Each subclass exhibits unique chemical properties and therapeutic applications. For instance, nitrogen mustards like cyclophosphamide and mechlorethamine are used to treat lymphomas and leukemia, while nitrosoureas such as carmustine and lomustine are effective against brain tumors.
The alkylating agents' mode of action involves the transfer of alkyl groups to cellular components, primarily DNA. This leads to the formation of DNA adducts, cross-links, and DNA strand breaks, ultimately hindering DNA replication and causing cell death. The indiscriminate nature of alkylating agents can also affect healthy cells, leading to various side effects such as bone marrow suppression and gastrointestinal disturbances.
Despite their potential side effects, alkylating agents remain valuable tools in cancer therapy due to their broad spectrum of activity against different types of tumors. Ongoing research focuses on developing more selective and targeted alkylating agents to improve their therapeutic index and minimize adverse effects. The use of alkylating agents in combination with other chemotherapy drugs or radiation therapy is also being explored to enhance treatment outcomes and reduce drug resistance.
In conclusion, alkylating agents are an essential subclass of pharmaceutical APIs widely employed in cancer treatment. Their ability to disrupt DNA structure and impede cell replication makes them effective against various types of tumors, although careful management of side effects is necessary. Ongoing advancements and research continue to refine their therapeutic potential in the fight against cancer.
Bendamustine (Alkylating agents), 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.
Bendamustine API manufacturers & distributors
Compare qualified Bendamustine API suppliers worldwide. We currently have 20 companies offering Bendamustine API, with manufacturing taking place in 5 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 |
|---|---|---|---|---|---|
| Beijing Huikang Boyuan | Producer | China | China | CoA, USDMF | 10 products |
| Biophore India | Producer | India | India | CoA, USDMF | 46 products |
| ChemPacific | Producer | United States | Unknown | CoA, USDMF | 10 products |
| Dr. Reddy's | Producer | India | India | BSE/TSE, CoA, EDMF/ASMF, FDA, GMP, KDMF, MSDS, USDMF, WC | 170 products |
| Emcure Pharma | Producer | India | India | CoA, GMP, USDMF, WC | 80 products |
| Fujian South Pharma | Producer | China | China | CoA, WC | 7 products |
| Fuxing Long Rui Pharma | Producer | China | China | CoA, USDMF | 10 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Heraeus | Producer | Germany | Germany | CoA, USDMF | 10 products |
| Hetero Labs | Producer | India | India | CoA, GMP, USDMF, WC | 90 products |
| Lianyungang Runzhong | Producer | China | China | CoA, USDMF | 6 products |
| MSN Labs. | Producer | India | India | CoA, USDMF | 119 products |
| Natco Pharma | Producer | India | India | CoA, USDMF, WC | 40 products |
| NAVINTA | Producer | United States | Unknown | CoA, USDMF | 15 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CoA, GMP, ISO9001, MSDS | 144 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Shilpa Medicare Ltd | Producer | India | India | BSE/TSE, CoA, EDMF/ASMF, GMP, ISO9001, MSDS, USDMF, WC | 54 products |
| Shivalik Rasayan Ltd. | Producer | India | India | CoA, GMP, USDMF, WC, WHO-GMP | 13 products |
| Sionc Pharma | Producer | India | India | CoA, WC | 10 products |
| Sun Pharma | Producer | India | India | CoA, USDMF | 219 products |
When sending a request, specify which Bendamustine 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 Bendamustine 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.
