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    Chemistry

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    Also known as: 3543-75-7, Bendamustine hcl, Treanda, Ribomustin, Cytostasan, Sdx-105
    Molecular Formula
    C16H22Cl3N3O2
    Molecular Weight
    394.7  g/mol
    InChI Key
    ZHSKUOZOLHMKEA-UHFFFAOYSA-N
    FDA UNII
    981Y8SX18M
    Bendamustine Hydrochloride
    A nitrogen mustard compound that functions as an ALKYLATING ANTINEOPLASTIC AGENT and is used in the treatment of CHRONIC LYMPHOCYTIC LEUKEMIA and NON-HODGKIN'S LYMPHOMA.
    1 2D Structure

    Bendamustine Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    4-[5-[bis(2-chloroethyl)amino]-1-methylbenzimidazol-2-yl]butanoic acid;hydrochloride
    2.1.2 InChI
    InChI=1S/C16H21Cl2N3O2.ClH/c1-20-14-6-5-12(21(9-7-17)10-8-18)11-13(14)19-15(20)3-2-4-16(22)23;/h5-6,11H,2-4,7-10H2,1H3,(H,22,23);1H
    2.1.3 InChI Key
    ZHSKUOZOLHMKEA-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CN1C2=C(C=C(C=C2)N(CCCl)CCCl)N=C1CCCC(=O)O.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    981Y8SX18M
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Bendamustin

    2. Bendamustine

    3. Cytostasan

    4. Hydrochloride, Bendamustine

    5. Imet 3393

    6. Ribomustin

    7. Treanda

    8. Zimet 3393

    2.3.2 Depositor-Supplied Synonyms

    1. 3543-75-7

    2. Bendamustine Hcl

    3. Treanda

    4. Ribomustin

    5. Cytostasan

    6. Sdx-105

    7. Bendamustin Hydrochloride

    8. Bendeka

    9. Imet 3393

    10. 4-(5-(bis(2-chloroethyl)amino)-1-methyl-1h-benzo[d]imidazol-2-yl)butanoic Acid Hydrochloride

    11. Syb L-0501

    12. Ribomustine

    13. Treakisym

    14. Bendamustine (hydrochloride)

    15. 4-[5-[bis(2-chloroethyl)amino]-1-methylbenzimidazol-2-yl]butanoic Acid Hydrochloride

    16. 97832-05-8

    17. Nsc-138783

    18. Sdx 105

    19. 3543-75-7 (hcl)

    20. Sybl-0501

    21. 981y8sx18m

    22. Levact

    23. 4-(5-(bis(2-chloroethyl)amino)-1-methyl-1h-benzo-[d]imidazol-2-yl)butanoic Acid Hydrochloride

    24. 4-[5-[bis(2-chloroethyl)amino]-1-methylbenzimidazol-2-yl]butanoic Acid;hydrochloride

    25. Treanda (tn)

    26. 1h-benzimidazole-2-butanoic Acid, 5-(bis(2-chloroethyl)amino)-1-methyl-, Monohydrochloride

    27. Bendit

    28. Ccris 1864

    29. Nsc 138783

    30. Cytostosan

    31. Innomustine

    32. Symbenda

    33. Benda

    34. Unii-981y8sx18m

    35. Treanda Hcl

    36. Zimet 33/93

    37. Ribomustin (tn)

    38. Bendamustine Hydrochloride Injection

    39. Vivimusta

    40. Inno-p08001

    41. Gamma(1-methyl-5-bis(beta-chloraethyl)aminobenzimidazoyl-2)buttersaeurehydrochlorid [german]

    42. Schembl18843

    43. Mls006010156

    44. Sdx-105 (cytostasane) Hcl

    45. Chembl1201734

    46. Dtxsid40188912

    47. Bcpp000348

    48. Bcp02107

    49. Hy-b0077

    50. Tox21_500623

    51. Mfcd01658758

    52. Nsc138783

    53. S1212

    54. Akos015951203

    55. Ac-1619

    56. Bcp9000390

    57. Bendamustine Hydrochloride (jan/usan)

    58. Bendamustine Hydrochloride [mi]

    59. Bendamustine Hydrochloride [usan:jan]

    60. Ccg-221927

    61. Cs-1771

    62. Ep-3101

    63. Lp00623

    64. Sb17462

    65. 2-benzimidazolebutyric Acid, 5-(bis(2-chloroethyl)amino)-1-methyl-, Monohydrochloride

    66. 2-benzimidazolinebutryric Acid, 1-methyl-5-bis(2-chloroethyl)amino-, Hydrochloride

    67. Bendamustine Hydrochloride [jan]

    68. Gamma(1-methyl-5-bis(beta-chloraethyl)aminobenzimidazoyl-2)buttersaeurehydrochlorid

    69. Bendamustine Hydrochloride [usan]

    70. Ncgc00261308-01

    71. As-15856

    72. Bb164239

    73. Bendamustine Hydrochloride [mart.]

    74. Bp-25399

    75. Smr004234484

    76. Bendamustine Hydrochloride [usp-rs]

    77. Bendamustine Hydrochloride [who-dd]

    78. Bendamustine Hcl (sdx-105, Cytostasane)

    79. 2-benzimidazolinebutryric Acid, Hydrochloride

    80. Am20090666

    81. B4033

    82. Ft-0650624

    83. Ft-0696296

    84. Sw219266-1

    85. 2-benzimidazolebutyric Acid, Monohydrochloride

    86. Bendamustine Hydrochloride [orange Book]

    87. D07085

    88. Wln: T56 Bn Dnj B1 C3vq Gn2g2g &gh

    89. 543b757

    90. Bendamustine Hydrochloride [usp Monograph]

    91. Q27272066

    92. Fmoc-(s)-3-amino-3-(3-trifluoromethyl-phenyl)-propionicacid

    93. 4-(5-(bis(2-chloroethyl)amino)-1-methylbenzimidazol-2-yl)butanoic Acid Hcl

    94. 4-(5-(bis(2-chloroethyl)amino)-1-methyl-1h-benzo[d]imidazol-2-yl)butanoicacidhydrochloride

    95. 5-[bis(2-chloroethyl)amino]-1-methyl-1h-benzimidazole-2-butanoic Acid Hydrochloride

    96. 5-[bis(2-chloroethyl)amino]-1-methylbenzimidazole-2-butyric Acid Hydrochloride

    97. 1h-benzimidazole-2-butanoic Acid, 5-[bis(2-chloroethyl)amino]-1-methyl-, Hydrochloride (1:1)

    98. 4-(5-(bis(2-chloroethyl)amino)-1-methyl-1h-benzimidazole-2-yl)butanoic Acid Monohydrochloride

    99. 5-[bis(2-chloroethyl)-amino]-1-methyl-1h-benzimidazole-2-butanoic Acid Hydrochloride;ribomustin Hcl

    2.4 Create Date
    2005-08-08
    3 Chemical and Physical Properties
    Molecular Weight 394.7 g/mol
    Molecular Formula C16H22Cl3N3O2
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count9
    Exact Mass393.077760 g/mol
    Monoisotopic Mass393.077760 g/mol
    Topological Polar Surface Area58.4 Ų
    Heavy Atom Count24
    Formal Charge0
    Complexity380
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameBendamustine hydrochloride
    PubMed HealthBendamustine (Injection)
    Drug ClassesAntineoplastic Agent
    Drug LabelTREANDA contains bendamustine hydrochloride, an alkylating drug, as the active ingredient. The chemical name of bendamustine hydrochloride is 1H-benzimidazole-2-butanoic acid, 5-[bis(2-chloroethyl)amino]-1 methyl-,monohydrochloride. Its empirical m...
    Active IngredientBendamustine hydrochloride
    Dosage FormInjectable
    Routeinjection
    Strength100mg
    Market StatusTentative Approval
    CompanyEagle Pharms

    2 of 4  
    Drug NameTreanda
    Drug LabelTREANDA contains bendamustine hydrochloride, an alkylating drug, as the active ingredient. The chemical name of bendamustine hydrochloride is 1H-benzimidazole-2-butanoic acid, 5-[bis(2-chloroethyl)amino]-1 methyl-,monohydrochloride. Its empirical m...
    Active IngredientBendamustine hydrochloride
    Dosage FormPowder; Injectable; Solution
    Routeinjection; Iv (infusion)
    Strength25mg/vial; 180mg/2ml (90mg/ml); 45mg/0.5ml (90mg/ml); 100mg/vial; 100mg
    Market StatusPrescription
    CompanyCephalon

    3 of 4  
    Drug NameBendamustine hydrochloride
    PubMed HealthBendamustine (Injection)
    Drug ClassesAntineoplastic Agent
    Drug LabelTREANDA contains bendamustine hydrochloride, an alkylating drug, as the active ingredient. The chemical name of bendamustine hydrochloride is 1H-benzimidazole-2-butanoic acid, 5-[bis(2-chloroethyl)amino]-1 methyl-,monohydrochloride. Its empirical m...
    Active IngredientBendamustine hydrochloride
    Dosage FormInjectable
    Routeinjection
    Strength100mg
    Market StatusTentative Approval
    CompanyEagle Pharms

    4 of 4  
    Drug NameTreanda
    Drug LabelTREANDA contains bendamustine hydrochloride, an alkylating drug, as the active ingredient. The chemical name of bendamustine hydrochloride is 1H-benzimidazole-2-butanoic acid, 5-[bis(2-chloroethyl)amino]-1 methyl-,monohydrochloride. Its empirical m...
    Active IngredientBendamustine hydrochloride
    Dosage FormPowder; Injectable; Solution
    Routeinjection; Iv (infusion)
    Strength25mg/vial; 180mg/2ml (90mg/ml); 45mg/0.5ml (90mg/ml); 100mg/vial; 100mg
    Market StatusPrescription
    CompanyCephalon

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Antineoplastic Agents, Alkylating

    A class of drugs that differs from other alkylating agents used clinically in that they are monofunctional and thus unable to cross-link cellular macromolecules. Among their common properties are a requirement for metabolic activation to intermediates with antitumor efficacy and the presence in their chemical structures of N-methyl groups, that after metabolism, can covalently modify cellular DNA. The precise mechanisms by which each of these drugs acts to kill tumor cells are not completely understood. (From AMA, Drug Evaluations Annual, 1994, p2026) (See all compounds classified as Antineoplastic Agents, Alkylating.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Alkylating Drug [EPC]; Alkylating Activity [MoA]

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    12-Jan-2021
    09-Dec-2024
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    DOSAGE - SOLUTION;INTRAVENOUS - 100MG/4ML (25...DOSAGE - SOLUTION;INTRAVENOUS - 100MG/4ML (25MG/ML)

    USFDA APPLICATION NUMBER - 205580

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    DOSAGE - SOLUTION;INTRAVENOUS - 100MG/4ML (25...DOSAGE - SOLUTION;INTRAVENOUS - 100MG/4ML (25MG/ML)

    USFDA APPLICATION NUMBER - 208194

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    DOSAGE - SOLUTION;INTRAVENOUS - 100MG/4ML (25...DOSAGE - SOLUTION;INTRAVENOUS - 100MG/4ML (25MG/ML)

    USFDA APPLICATION NUMBER - 215033

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    ABOUT THIS PAGE

    Looking for 3543-75-7 / Bendamustine API manufacturers, exporters & distributors?

    Bendamustine manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Bendamustine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Bendamustine manufacturer or Bendamustine supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bendamustine manufacturer or Bendamustine supplier.

    PharmaCompass also assists you with knowing the Bendamustine API Price utilized in the formulation of products. Bendamustine API Price is not always fixed or binding as the Bendamustine Price is obtained through a variety of data sources. The Bendamustine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Bendamustine

    Synonyms

    3543-75-7, Bendamustine hcl, Treanda, Ribomustin, Cytostasan, Sdx-105

    Cas Number

    3543-75-7

    Unique Ingredient Identifier (UNII)

    981Y8SX18M

    About Bendamustine

    A nitrogen mustard compound that functions as an ALKYLATING ANTINEOPLASTIC AGENT and is used in the treatment of CHRONIC LYMPHOCYTIC LEUKEMIA and NON-HODGKIN'S LYMPHOMA.

    Bendamustine Hydrochloride Manufacturers

    A Bendamustine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bendamustine Hydrochloride, including repackagers and relabelers. The FDA regulates Bendamustine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bendamustine Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Bendamustine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Bendamustine Hydrochloride Suppliers

    A Bendamustine Hydrochloride supplier is an individual or a company that provides Bendamustine Hydrochloride active pharmaceutical ingredient (API) or Bendamustine Hydrochloride finished formulations upon request. The Bendamustine Hydrochloride suppliers may include Bendamustine Hydrochloride API manufacturers, exporters, distributors and traders.

    click here to find a list of Bendamustine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Bendamustine Hydrochloride USDMF

    A Bendamustine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Bendamustine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Bendamustine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Bendamustine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Bendamustine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Bendamustine Hydrochloride USDMF includes data on Bendamustine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bendamustine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Bendamustine Hydrochloride suppliers with USDMF on PharmaCompass.

    Bendamustine Hydrochloride JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Bendamustine Hydrochloride Drug Master File in Japan (Bendamustine Hydrochloride JDMF) empowers Bendamustine Hydrochloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Bendamustine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Bendamustine Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Bendamustine Hydrochloride suppliers with JDMF on PharmaCompass.

    Bendamustine Hydrochloride KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Bendamustine Hydrochloride Drug Master File in Korea (Bendamustine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Bendamustine Hydrochloride. The MFDS reviews the Bendamustine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Bendamustine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Bendamustine Hydrochloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Bendamustine Hydrochloride API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Bendamustine Hydrochloride suppliers with KDMF on PharmaCompass.

    Bendamustine Hydrochloride WC

    A Bendamustine Hydrochloride written confirmation (Bendamustine Hydrochloride WC) is an official document issued by a regulatory agency to a Bendamustine Hydrochloride manufacturer, verifying that the manufacturing facility of a Bendamustine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Bendamustine Hydrochloride APIs or Bendamustine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Bendamustine Hydrochloride WC (written confirmation) as part of the regulatory process.

    click here to find a list of Bendamustine Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.

    Bendamustine Hydrochloride NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Bendamustine Hydrochloride as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Bendamustine Hydrochloride API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Bendamustine Hydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Bendamustine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bendamustine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Bendamustine Hydrochloride suppliers with NDC on PharmaCompass.

    Bendamustine Hydrochloride GMP

    Bendamustine Hydrochloride Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Bendamustine Hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Bendamustine Hydrochloride GMP manufacturer or Bendamustine Hydrochloride GMP API supplier for your needs.

    Bendamustine Hydrochloride CoA

    A Bendamustine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Bendamustine Hydrochloride's compliance with Bendamustine Hydrochloride specifications and serves as a tool for batch-level quality control.

    Bendamustine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Bendamustine Hydrochloride CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Bendamustine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Bendamustine Hydrochloride EP), Bendamustine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bendamustine Hydrochloride USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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