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Chemistry

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Also known as: 104344-23-2, Zebeta, Bisoprolol hemifumarate, Bisoprolol monofumarate, Fondril, Maintate
Molecular Formula
C22H35NO8
Molecular Weight
441.5  g/mol
InChI Key
RZPZLFIUFMNCLY-WLHGVMLRSA-N
FDA UNII
U057CX04H0

Bisoprolol Fumarate
A cardioselective beta-1 adrenergic blocker. It is effective in the management of HYPERTENSION and ANGINA PECTORIS.
1 2D Structure

Bisoprolol Fumarate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(E)-but-2-enedioic acid;1-(propan-2-ylamino)-3-[4-(2-propan-2-yloxyethoxymethyl)phenoxy]propan-2-ol
2.1.2 InChI
InChI=1S/C18H31NO4.C4H4O4/c1-14(2)19-11-17(20)13-23-18-7-5-16(6-8-18)12-21-9-10-22-15(3)4;5-3(6)1-2-4(7)8/h5-8,14-15,17,19-20H,9-13H2,1-4H3;1-2H,(H,5,6)(H,7,8)/b;2-1+
2.1.3 InChI Key
RZPZLFIUFMNCLY-WLHGVMLRSA-N
2.1.4 Canonical SMILES
CC(C)NCC(COC1=CC=C(C=C1)COCCOC(C)C)O.C(=CC(=O)O)C(=O)O
2.1.5 Isomeric SMILES
CC(C)NCC(COC1=CC=C(C=C1)COCCOC(C)C)O.C(=C/C(=O)O)\C(=O)O
2.2 Other Identifiers
2.2.1 UNII
U057CX04H0
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Bisoprolol

2. Bisoprolol Fumarate (1:1) Salt, (+-)-isomer

3. Bisoprolol Fumarate (2:1) Salt, (+-)-isomer

4. Bisoprolol Hydrochloride

5. Bisoprolol Methanesulfonate Salt

6. Bisoprolol, (+-)-isomer

7. Bisoprolol, (-)-isomer

8. Bisoprolol, Fumarate (1:1) Salt

9. Bisoprolol, Fumarate (2:1) Salt

10. Cl 297939

11. Cl-297939

12. Cl297939

13. Concor

14. Emd 33512

15. Emd-33512

16. Emd33512

17. Fumarate, Bisoprolol

18. Hydrochloride, Bisoprolol

2.3.2 Depositor-Supplied Synonyms

1. 104344-23-2

2. Zebeta

3. Bisoprolol Hemifumarate

4. Bisoprolol Monofumarate

5. Fondril

6. Maintate

7. Concor

8. 105878-43-1

9. Bisoprolol (fumarate)

10. Bisoprolol Hemifumarate Salt

11. U057cx04h0

12. Emd33512

13. Ta-4708

14. Cl-297939

15. 1-[4-[[2-(1-methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol,(2e)-2-monobutenedioate

16. 2-propanol, 1-(4-((2-(1-methylethoxy)ethoxy)methyl)phenoxy)-3-((1-methylethyl)amino)-, (2e)-2-butenedioate (1:1)

17. 2-propanol, 1-(4-((2-(1-methylethoxy)ethoxy)methyl)phenoxy)-3-((1-methylethyl)amino)-, (2e)-2-butenedioate (1:1) (salt)

18. 2-propanol, 1-(4-((2-(1-methylethoxy)ethoxy)methyl)phenoxy)-3-((1-methylethyl)amino)-, (e)-2-butenedioate (1:1) (salt)

19. Smr000471619

20. Emd-33512

21. Bisocard

22. Cardicor

23. Congescor

24. Sr-01000597980

25. Bisoprololfumarate

26. Concor Cor

27. 66722-45-0

28. Bisoprolol Fumarate (1:x)

29. Schembl41419

30. Mls001076669

31. Mls001401436

32. Unii-u057cx04h0

33. Chembl1200708

34. Bcpp000331

35. Hms1569a21

36. Hms2051i16

37. Hms2094o19

38. Hms2233f12

39. Hms3884o05

40. Pharmakon1600-01505704

41. Nsc759181

42. S1206

43. Akos005267174

44. Ac-5016

45. Bcp9000419

46. Ccg-100883

47. Ccg-213520

48. Nc00133

49. Nsc-759181

50. Hy-120829

51. B3994

52. Cs-0079270

53. Sw197151-3

54. 104b232

55. Q-200729

56. Sr-01000597980-4

57. Q27290514

58. 1-(4-((2-isopropoxyethoxy)methyl)phenoxy)-3-(isopropylamino)propan-2-ol Hemi-fumarate

59. 1-{4-[(2-isopropoxyethoxy)methyl]phenoxy}-3-(isopropylamino)-2-propanol Fumaric Acid Salt

2.4 Create Date
2006-07-28
3 Chemical and Physical Properties
Molecular Weight 441.5 g/mol
Molecular Formula C22H35NO8
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count9
Rotatable Bond Count14
Exact Mass441.23626707 g/mol
Monoisotopic Mass441.23626707 g/mol
Topological Polar Surface Area135 Ų
Heavy Atom Count31
Formal Charge0
Complexity397
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameBisoprolol fumarate
Drug LabelBisoprolol fumarate is a synthetic, beta1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is ()-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate...
Active IngredientBisoprolol fumarate
Dosage FormTablet
RouteOral
Strength5mg; 10mg
Market StatusPrescription
CompanyTeva Pharms; Unichem Pharms (usa); Aurobindo Pharma; Sandoz; Mylan

2 of 4  
Drug NameZebeta
PubMed HealthBisoprolol (By mouth)
Drug ClassesAntianginal, Antihypertensive, Cardiovascular Agent
Drug LabelZEBETA (bisoprolol fumarate) is a synthetic, beta1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is ()-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-but...
Active IngredientBisoprolol fumarate
Dosage FormTablet
RouteOral
Strength5mg; 10mg
Market StatusPrescription
CompanyTeva Womens

3 of 4  
Drug NameBisoprolol fumarate
Drug LabelBisoprolol fumarate is a synthetic, beta1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is ()-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate...
Active IngredientBisoprolol fumarate
Dosage FormTablet
RouteOral
Strength5mg; 10mg
Market StatusPrescription
CompanyTeva Pharms; Unichem Pharms (usa); Aurobindo Pharma; Sandoz; Mylan

4 of 4  
Drug NameZebeta
PubMed HealthBisoprolol (By mouth)
Drug ClassesAntianginal, Antihypertensive, Cardiovascular Agent
Drug LabelZEBETA (bisoprolol fumarate) is a synthetic, beta1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is ()-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-but...
Active IngredientBisoprolol fumarate
Dosage FormTablet
RouteOral
Strength5mg; 10mg
Market StatusPrescription
CompanyTeva Womens

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Adrenergic beta-1 Receptor Antagonists

Drugs that bind to and block the activation of ADRENERGIC BETA-1 RECEPTORS. (See all compounds classified as Adrenergic beta-1 Receptor Antagonists.)


Antihypertensive Agents

Drugs used in the treatment of acute or chronic vascular HYPERTENSION regardless of pharmacological mechanism. Among the antihypertensive agents are DIURETICS; (especially DIURETICS, THIAZIDE); ADRENERGIC BETA-ANTAGONISTS; ADRENERGIC ALPHA-ANTAGONISTS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CALCIUM CHANNEL BLOCKERS; GANGLIONIC BLOCKERS; and VASODILATOR AGENTS. (See all compounds classified as Antihypertensive Agents.)


Sympatholytics

Drugs that inhibit the actions of the sympathetic nervous system by any mechanism. The most common of these are the ADRENERGIC ANTAGONISTS and drugs that deplete norepinephrine or reduce the release of transmitters from adrenergic postganglionic terminals (see ADRENERGIC AGENTS). Drugs that act in the central nervous system to reduce sympathetic activity (e.g., centrally acting alpha-2 adrenergic agonists, see ADRENERGIC ALPHA-AGONISTS) are included here. (See all compounds classified as Sympatholytics.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
beta-Adrenergic Blocker [EPC]; Adrenergic beta-Antagonists [MoA]

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04-Jan-2022
29-May-2025
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DOSAGE - TABLET;ORAL - 10MG **Federal Registe...DOSAGE - TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19982

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DOSAGE - TABLET;ORAL - 5MG **Federal Register...DOSAGE - TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19982

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ABOUT THIS PAGE

Looking for 105878-43-1 / Bisoprolol Fumarate API manufacturers, exporters & distributors?

Bisoprolol Fumarate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Bisoprolol Fumarate 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 Bisoprolol Fumarate manufacturer or Bisoprolol Fumarate supplier for your needs.

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

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

API | Excipient name

Bisoprolol Fumarate

Synonyms

104344-23-2, Zebeta, Bisoprolol hemifumarate, Bisoprolol monofumarate, Fondril, Maintate

Cas Number

105878-43-1

Unique Ingredient Identifier (UNII)

U057CX04H0

About Bisoprolol Fumarate

A cardioselective beta-1 adrenergic blocker. It is effective in the management of HYPERTENSION and ANGINA PECTORIS.

Concor COR Manufacturers

A Concor COR manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Concor COR, including repackagers and relabelers. The FDA regulates Concor COR manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Concor COR 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 Concor COR manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Concor COR Suppliers

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

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

Concor COR USDMF

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

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

click here to find a list of Concor COR suppliers with USDMF on PharmaCompass.

Concor COR 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 Concor COR Drug Master File in Japan (Concor COR JDMF) empowers Concor COR 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 Concor COR JDMF during the approval evaluation for pharmaceutical products. At the time of Concor COR 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 Concor COR suppliers with JDMF on PharmaCompass.

Concor COR KDMF

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

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

After submitting a Concor COR 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 Concor COR API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Concor COR suppliers with KDMF on PharmaCompass.

Concor COR CEP

A Concor COR CEP of the European Pharmacopoeia monograph is often referred to as a Concor COR Certificate of Suitability (COS). The purpose of a Concor COR CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Concor COR EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Concor COR to their clients by showing that a Concor COR CEP has been issued for it. The manufacturer submits a Concor COR CEP (COS) as part of the market authorization procedure, and it takes on the role of a Concor COR CEP holder for the record. Additionally, the data presented in the Concor COR CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Concor COR DMF.

A Concor COR CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Concor COR CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Concor COR suppliers with CEP (COS) on PharmaCompass.

Concor COR WC

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

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

Concor COR 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 Concor COR as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Concor COR 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 Concor COR 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 Concor COR and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Concor COR NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Concor COR suppliers with NDC on PharmaCompass.

Concor COR GMP

Concor COR 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 Concor COR 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 Concor COR GMP manufacturer or Concor COR GMP API supplier for your needs.

Concor COR CoA

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

Concor COR CoA mostly includes findings from lab analyses of a specific batch. For each Concor COR 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.

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