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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]

    API Reference Price

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GUJARAT","supplier":"MOEHS IBERICA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"TORRENT PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"15.70","actualQuantity":"15.7","unit":"KGS","unitRateFc":"600","totalValueFC":"9528.1","currency":"USD","unitRateINR":"50730","date":"25-Jul-2024","totalValueINR":"796461","totalValueInUsd":"9528.1","indian_port":"Ahmedabad Air","hs_no":"29221990","bill_no":"4686487","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"POLIGANO RUBI SUR CESAR MARTINELL IBRUNET 12 A, RUBI (BARCELONA) -08191 BARCELONA SPAIN","customerAddress":"TORRENT HOUSE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721845800,"product":"CHEMICAL : BISOPROLOL FUMARATE USP","address":"TORRENT HOUSE,","city":"AHMEDABAD. GUJARAT","supplier":"MOEHS IBERICA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"TORRENT PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"31.57","actualQuantity":"31.568","unit":"KGS","unitRateFc":"600","totalValueFC":"19158.1","currency":"USD","unitRateINR":"50730","date":"25-Jul-2024","totalValueINR":"1601444.64","totalValueInUsd":"19158.1","indian_port":"Ahmedabad Air","hs_no":"29221990","bill_no":"4686487","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"POLIGANO RUBI SUR CESAR MARTINELL IBRUNET 12 A, RUBI (BARCELONA) -08191 BARCELONA SPAIN","customerAddress":"TORRENT HOUSE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721845800,"product":"BISOPROLOL FUMARATE","address":"MEDREICH HOUSE, NO12\/8,","city":"SEVA NAGAR, BANGALORE, KARNATAKA","supplier":"MOEHS IBERICA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"MEDREICH","customerCountry":"INDIA","quantity":"35.00","actualQuantity":"35","unit":"KGS","unitRateFc":"316.9","totalValueFC":"12298.6","currency":"EUR","unitRateINR":"29372.9","date":"25-Jul-2024","totalValueINR":"1028052.27","totalValueInUsd":"12298.6","indian_port":"Bangalore Air","hs_no":"29420090","bill_no":"4696701","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"C\/ CESAR MARTINELL I BRUNET, 12A08191 RUBIBARCELONA SPAIN","customerAddress":"MEDREICH HOUSE, NO12\/8,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725301800,"product":"BISOPROLOL FUMARATE USP","address":"221, GOREGAON-MULUND LINK ROAD,","city":"BHANDUP WEST, MUMBAI","supplier":"AREVIPHARMA","supplierCountry":"GERMANY","foreign_port":"DRESDEN","customer":"RUBICON RESEARCH","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"520","totalValueFC":"26325.4","currency":"USD","unitRateINR":"44122","date":"03-Sep-2024","totalValueINR":"2206100","totalValueInUsd":"26325.4","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"5401982","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"DRESDEN","supplierAddress":"MEISSNER STRASSE 35 01445 RADEBEUL GERMANY DE DE","customerAddress":"221, GOREGAON-MULUND LINK ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729708200,"product":"CHEMICAL : BISOPROLOL FUMARATE USP","address":"TORRENT HOUSE,","city":"AHMEDABAD. GUJARAT","supplier":"MOEHS IBERICA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"TORRENT PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"2.52","actualQuantity":"2.518","unit":"KGS","unitRateFc":"600","totalValueFC":"1527.4","currency":"USD","unitRateINR":"50970","date":"24-Oct-2024","totalValueINR":"128342.46","totalValueInUsd":"1527.4","indian_port":"Ahmedabad Air","hs_no":"29221990","bill_no":"6307113","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"POLIGANO RUBI SUR CESAR MARTINELL I BRUNET 12 A, RUBI (BARCELONA) -081 91 BARCELONA SPAIN","customerAddress":"TORRENT HOUSE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729708200,"product":"CHEMICAL : BISOPROLOL FUMARATE USP","address":"TORRENT HOUSE,","city":"AHMEDABAD. GUJARAT","supplier":"MOEHS IBERICA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"TORRENT PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"47.65","actualQuantity":"47.65","unit":"KGS","unitRateFc":"600","totalValueFC":"28904.2","currency":"USD","unitRateINR":"50970","date":"24-Oct-2024","totalValueINR":"2428720.5","totalValueInUsd":"28904.2","indian_port":"Ahmedabad Air","hs_no":"29221990","bill_no":"6307113","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"POLIGANO RUBI SUR CESAR MARTINELL I BRUNET 12 A, RUBI (BARCELONA) -081 91 BARCELONA SPAIN","customerAddress":"TORRENT HOUSE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731954600,"product":"BISOPROLOL FUMARATE","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"MOEHS IBERICA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"VIATRIS","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"517","totalValueFC":"26129.3","currency":"USD","unitRateINR":"44100.1","date":"19-Nov-2024","totalValueINR":"2205005","totalValueInUsd":"26129.3","indian_port":"Bombay Air","hs_no":"29221190","bill_no":"6754038","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"C\/ CESAR MARTINELL I BRUNET 12A, CO RRESPOND, C\/ROMA, 8-12 08191-RUBI-B CN 08191-RUBI, BARCELONA Spain Spain","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733423400,"product":"BISOPROLOL FUMARATE","address":"107A,VINAY BHAVYA COMPLEX","city":"MUMBAI ,MAHARASHTRA","supplier":"MOEHS IBERICA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"HARMAN FINOCHEM","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"600","totalValueFC":"15120.2","currency":"USD","unitRateINR":"51390","date":"06-Dec-2024","totalValueINR":"1284750","totalValueInUsd":"15120.2","indian_port":"Bombay Air","hs_no":"29221990","bill_no":"7085720","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"C\/CESAR MARTINELL I BRUNET, 12A 08191 RUBI, BARCELONA SDNF ES","customerAddress":"107A,VINAY BHAVYA COMPLEX"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737743400,"product":"BISOPROLOL FUMARATE (USP\/IP) BISOPROLOL FUMARATE (USP\/IP)","address":"7TH FLOOR, SHIVSAGAR ESTATE A,","city":"MUMBAI, MAHARASHTRA","supplier":"MERCK & CIE KMG","supplierCountry":"SWITZERLAND","foreign_port":"ZURICH","customer":"MERCK SPECIALITIES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"75.00","actualQuantity":"75","unit":"KGS","unitRateFc":"1029.2","totalValueFC":"77970.8","currency":"INR","unitRateINR":"89644.8","date":"25-Jan-2025","totalValueINR":"6723360","totalValueInUsd":"77970.8","indian_port":"Bombay Air","hs_no":"29221990","bill_no":"7991201","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"ZURICH","supplierAddress":"WIESSHAUSMATTE 6460 ALTDORF UR 1,(B ENEFICIARY MERCK FINANCIALSERVICESG MBH)","customerAddress":"7TH FLOOR, SHIVSAGAR ESTATE A,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1739903400,"product":"BISOPROLOL FUMARATE (USP\/IP) ORGANIC CHEMICAL","address":"7TH FLOOR, SHIVSAGAR ESTATE A,","city":"MUMBAI, MAHARASHTRA","supplier":"MERCK & CIE KMG","supplierCountry":"SWITZERLAND","foreign_port":"ZURICH","customer":"MERCK SPECIALITIES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"180.00","actualQuantity":"180","unit":"KGS","unitRateFc":"1014.1","totalValueFC":"185548.6","currency":"N\/A","unitRateINR":"89644.8","date":"19-Feb-2025","totalValueINR":"16136064","totalValueInUsd":"185548.6","indian_port":"Bombay Air","hs_no":"29221990","bill_no":"8439816","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"ZURICH","supplierAddress":"WIESSHAUSMATTE 6460 ALTDORF UR 1,(B ENEFICIARY MERCK FINANCIALSERVICESG MBH) SWITZERLAND","customerAddress":"7TH FLOOR, SHIVSAGAR ESTATE A,"}]
    11-Jan-2021
    29-Mar-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.

    Monocor Manufacturers

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

    Monocor Suppliers

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

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

    Monocor USDMF

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

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

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

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

    Monocor KDMF

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

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

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

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

    Monocor CEP

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

    A Monocor CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Monocor 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 Monocor suppliers with CEP (COS) on PharmaCompass.

    Monocor WC

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

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

    Monocor 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 Monocor as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Monocor GMP

    Monocor 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 Monocor 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 Monocor GMP manufacturer or Monocor GMP API supplier for your needs.

    Monocor CoA

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

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

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