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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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04-Feb-2022
28-Mar-2025
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DRUG PRODUCT COMPOSITIONS

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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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