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    Chemistry

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    Also known as: 86541-74-4, Benazepril hcl, Lotensin, Cibacen, Cibacene, Briem
    Molecular Formula
    C24H29ClN2O5
    Molecular Weight
    460.9  g/mol
    InChI Key
    VPSRQEHTHIMDQM-FKLPMGAJSA-N
    FDA UNII
    N1SN99T69T
    Benazepril Hydrochloride
    Benazepril Hydrochloride is the hydrochloride salt of benazepril, a carboxyl-containing angiotensin-converting enzyme (ACE) inhibitor with antihypertensive activity. As a prodrug, benazepril is metabolized to its active form benazeprilat. Benazeprilat competitively binds to and inhibits ACE, thereby blocking the conversion of angiotensin I to angiotensin II. This prevents the potent vasoconstrictive actions of angiotensin II, resulting in vasodilation. Benazeprilat also decreases angiotensin II-induced aldosterone secretion by the adrenal cortex, which leads to an increase in sodium excretion and subsequently increases water outflow.
    1 2D Structure

    Benazepril Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-[(3S)-3-[[(2S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl]amino]-2-oxo-4,5-dihydro-3H-1-benzazepin-1-yl]acetic acid;hydrochloride
    2.1.2 InChI
    InChI=1S/C24H28N2O5.ClH/c1-2-31-24(30)20(14-12-17-8-4-3-5-9-17)25-19-15-13-18-10-6-7-11-21(18)26(23(19)29)16-22(27)28;/h3-11,19-20,25H,2,12-16H2,1H3,(H,27,28);1H/t19-,20-;/m0./s1
    2.1.3 InChI Key
    VPSRQEHTHIMDQM-FKLPMGAJSA-N
    2.1.4 Canonical SMILES
    CCOC(=O)C(CCC1=CC=CC=C1)NC2CCC3=CC=CC=C3N(C2=O)CC(=O)O.Cl
    2.1.5 Isomeric SMILES
    CCOC(=O)[C@H](CCC1=CC=CC=C1)N[C@H]2CCC3=CC=CC=C3N(C2=O)CC(=O)O.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    N1SN99T69T
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Benazapril

    2. Benazepril

    3. Benzazepril

    4. Briem

    5. Cgs-14824-a

    6. Cgs-14824a

    7. Cibacne

    8. Cibacen

    9. Labopal

    10. Lotensin

    2.3.2 Depositor-Supplied Synonyms

    1. 86541-74-4

    2. Benazepril Hcl

    3. Lotensin

    4. Cibacen

    5. Cibacene

    6. Briem

    7. Tensanil

    8. Zinadril

    9. Cibace

    10. Labopol

    11. Cgs 14824a Hcl

    12. Benazepril (hydrochloride)

    13. Cgs 14824a

    14. Nsc-758920

    15. Cgs-14824a Hcl

    16. Chebi:3012

    17. N1sn99t69t

    18. (3s)-3-(((1s)-1-carboxy-3-phenylpropyl)amino)-2,3,4,5-tetrahydro-2-oxo-1h-1-benzazepine-1-acetic Acid, 3-ethyl Ester, Monohydrochloride

    19. (3s)-3-[[(1s)-1-(ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1h-1-benzazepine-1-acetic Acid Hydrochloride

    20. 86541-74-4 (hcl)

    21. Cibacen Chf

    22. Dsstox_cid_25922

    23. Dsstox_rid_81225

    24. Dsstox_gsid_45922

    25. 1h-1-benzazepine-1-acetic Acid, 3-((1-(ethoxycarbonyl)-3-phenylpropyl)amino)-2,3,4,5-tetrahydro-2-oxo-, Monohydrochloride, (s-(r*,r*))-

    26. 2-((s)-3-(((s)-1-ethoxy-1-oxo-4-phenylbutan-2-yl)amino)-2-oxo-2,3,4,5-tetrahydro-1h-benzo[b]azepin-1-yl)acetic Acid Hydrochloride

    27. 2-[(3s)-3-[[(2s)-1-ethoxy-1-oxo-4-phenylbutan-2-yl]amino]-2-oxo-4,5-dihydro-3h-1-benzazepin-1-yl]acetic Acid;hydrochloride

    28. 2-[(3s)-3-{[(2s)-1-ethoxy-1-oxo-4-phenylbutan-2-yl]amino}-2-oxo-2,3,4,5-tetrahydro-1h-1-benzazepin-1-yl]acetic Acid Hydrochloride

    29. Smr000469199

    30. Cas-86541-74-4

    31. Mfcd00895734

    32. Unii-n1sn99t69t

    33. Ncgc00095132-01

    34. Lotensin (tn)

    35. 2-((s)-3-((s)-1-ethoxy-1-oxo-4-phenylbutan-2-ylamino)-2-oxo-2,3,4,5-tetrahydro-1h-benzo[b]azepin-1-yl)acetic Acid Hydrochloride

    36. Benazeprilhydrochloride

    37. Benazepril Hydrochloride [usan:usp:jan]

    38. Benazepril Monohydrochloride

    39. Chembl1694

    40. Schembl42194

    41. Benazepril Hydrochloride,(s)

    42. Mls001076668

    43. Mls001333171

    44. Mls001333172

    45. Mls001401429

    46. Spectrum1505200

    47. Benazepril Hydrochloride- Bio-x

    48. Dtxsid9045922

    49. Benazepril For System Suitability

    50. Hy-b0093a

    51. Bcpp000350

    52. Hms1922l07

    53. Pharmakon1600-01505200

    54. Twt-8154

    55. Benazepril Hydrochloride (jan/usp)

    56. Tox21_111441

    57. Benazepril Hydrochloride [mi]

    58. Ccg-39520

    59. Nsc758920

    60. S1284

    61. Benazepril Hydrochloride [jan]

    62. Akos015888536

    63. Tox21_111441_1

    64. Bcp9000387

    65. Benazepril Hydrochloride [hsdb]

    66. Benazepril Hydrochloride [usan]

    67. Cs-1796

    68. Ks-1397

    69. Nc00211

    70. Nsc 758920

    71. Benazepril Hydrochloride [mart.]

    72. Benazepril Hydrochloride [usp-rs]

    73. Benazepril Hydrochloride [who-dd]

    74. Ncgc00165740-05

    75. (3s)-3-[(1s)-1-ethoxycarbonyl-3-phenylpropyl]amino-2,3,4,5-tetrahydro-2-oxo-1h-1-benzazepine-1-acetic Acid Hydrochloride

    76. 1h-1-benzazepine-1-acetic Acid, 2,3,4,5-tetrahydro-3-((1-(ethoxycarbonyl)-3-phenylpropyl)amino)-2-oxo-, Monohydrochloride, (s-(r*,r*))-

    77. Bb164237

    78. B3611

    79. Sw197591-3

    80. Benazepril Hydrochloride [ep Impurity]

    81. Benazepril Hydrochloride [orange Book]

    82. Benazepril Hydrochloride [usp Impurity]

    83. Benazepril Hydrochloride [usp Monograph]

    84. C07701

    85. D00620

    86. Lotrel Component Benazepril Hydrochloride

    87. Benazepril Hydrochloride, >=98% (hplc), Solid

    88. A841712

    89. Benazepril Hydrochloride Component Cardalis

    90. Benazepril Hydrochloride Component Of Lotrel

    91. Cardalis Component Benazepril Hydrochloride

    92. Sr-01000762893

    93. Sr-01000762893-3

    94. Benazepril Hydrochloride [ema Epar Veterinary]

    95. Fortekor Plus Component Benazepril Hydrochloride

    96. Lotensin Hct Component Benazepril Hydrochloride

    97. Q27105927

    98. Benazepril Hydrochloride Component Of Lotensin Hct

    99. Benazepril Hydrochloride Component Of Fortekor Plus

    100. Benazepril Hydrochloride, Vetranal(tm), Analytical Standard

    101. Benazepril Hydrochloride, European Pharmacopoeia (ep) Reference Standard

    102. Benazepril For System Suitability, European Pharmacopoeia (ep) Reference Standard

    103. Benazepril Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

    104. Benazepril Hydrochloride, United States Pharmacopeia (usp) Reference Standard

    105. [(3s)-3-{[(2s)-1-ethoxy-1-oxo-4-phenylbutan-2-yl]amino}-2-oxo-2,3,4,5-tetrahydro-1h-1-benzazepin-1-yl]acetic Acid Hydrochloride

    106. 2-[(3s)-3-[[(1s)-1-ethoxycarbonyl-3-phenyl-propyl]amino]-2-oxo-4,5-dihydro-3h-1-benzazepin-1-yl]acetic Acid Hydrochloride;benazepril Hydrochloride

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 460.9 g/mol
    Molecular Formula C24H29ClN2O5
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count10
    Exact Mass460.1764997 g/mol
    Monoisotopic Mass460.1764997 g/mol
    Topological Polar Surface Area95.9 Ų
    Heavy Atom Count32
    Formal Charge0
    Complexity619
    Isotope Atom Count0
    Defined Atom Stereocenter Count2
    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 NameBenazepril hydrochloride
    PubMed HealthBenazepril (By mouth)
    Drug ClassesAntihypertensive, Cardiovascular Agent, Renal Protective Agent
    Drug LabelBenazepril hydrochloride is a white to off-white crystalline powder, soluble (> 100 mg/mL) in water, in ethanol, and in methanol. BenazeprilC24H28N2O5HCl M.W. 460.96Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-co..
    Active IngredientBenazepril hydrochloride
    Dosage FormTablet
    RouteOral
    Strength5mg; 10mg; 40mg; 20mg
    Market StatusPrescription
    CompanyRanbaxy; Ivax Sub Teva Pharms; Actavis Labs Fl; Teva; Apotex; Aurobindo Pharma; Zydus Pharms Usa; Biokey; Sandoz; Prinston; Mylan

    2 of 4  
    Drug NameLotensin
    Drug LabelBenazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is benazepril 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-be..
    Active IngredientBenazepril hydrochloride
    Dosage FormTablet
    RouteOral
    Strength5mg; 10mg; 40mg; 20mg
    Market StatusPrescription
    CompanyUs Pharms Holdings I

    3 of 4  
    Drug NameBenazepril hydrochloride
    PubMed HealthBenazepril (By mouth)
    Drug ClassesAntihypertensive, Cardiovascular Agent, Renal Protective Agent
    Drug LabelBenazepril hydrochloride is a white to off-white crystalline powder, soluble (> 100 mg/mL) in water, in ethanol, and in methanol. BenazeprilC24H28N2O5HCl M.W. 460.96Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-co..
    Active IngredientBenazepril hydrochloride
    Dosage FormTablet
    RouteOral
    Strength5mg; 10mg; 40mg; 20mg
    Market StatusPrescription
    CompanyRanbaxy; Ivax Sub Teva Pharms; Actavis Labs Fl; Teva; Apotex; Aurobindo Pharma; Zydus Pharms Usa; Biokey; Sandoz; Prinston; Mylan

    4 of 4  
    Drug NameLotensin
    Drug LabelBenazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is benazepril 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-be..
    Active IngredientBenazepril hydrochloride
    Dosage FormTablet
    RouteOral
    Strength5mg; 10mg; 40mg; 20mg
    Market StatusPrescription
    CompanyUs Pharms Holdings I

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Angiotensin-Converting Enzyme Inhibitors

    A class of drugs whose main indications are the treatment of hypertension and heart failure. They exert their hemodynamic effect mainly by inhibiting the renin-angiotensin system. They also modulate sympathetic nervous system activity and increase prostaglandin synthesis. They cause mainly vasodilation and mild natriuresis without affecting heart rate and contractility. (See all compounds classified as Angiotensin-Converting Enzyme Inhibitors.)

    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.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Angiotensin-converting Enzyme Inhibitors [MoA]; Decreased Blood Pressure [PE]; Angiotensin Converting Enzyme Inhibitor [EPC]

    API Reference Price

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CHINASDNF CHINA","customerAddress":"304,ATLANTA ARCADE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724783400,"product":"BENAZEPRIL HYDROCHLORIDE USP","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"140.00","actualQuantity":"140","unit":"KGS","unitRateFc":"600","totalValueFC":"84972.9","currency":"USD","unitRateINR":"50910","date":"28-Aug-2024","totalValueINR":"7127400","totalValueInUsd":"84972.9","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"5292119","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"XUNQIAO, LINHAI, ZHEJIANG, 317024 CHINA ChinaSDNF China","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1727721000,"product":"BENAZEPRIL HYDROCHLORIDE USP AMNEAL LOT: 22090758 MFG LOT: 70662AA111 MFG: 09\/11\/26 EXP: 01\/11\/26BENAZEPRIL HYDROCHLORIDE USP AMNEAL LOT: 22090758 MFG LOT: 7","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"AMNEAL PHARMACEUTICALS","supplierCountry":"UNITED STATES","foreign_port":"NEWARK APT\/NEW YORK","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"229.51","actualQuantity":"229.505","unit":"KGS","unitRateFc":"1349.3","totalValueFC":"311775.3","currency":"USD","unitRateINR":"114147.4","date":"01-Oct-2024","totalValueINR":"26197399.8","totalValueInUsd":"311775.3","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29337990","bill_no":"5892904","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NEWARK APT\/NEW YORK","supplierAddress":"50 HORSEBLOCK RD NY, 11719 11719 US","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728844200,"product":"BENAZEPRIL HYDROCHLORIDE","address":"304,ATLANTA ARCADE,","city":"MUMBAI MAHARASHTRA","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"MACLEODS PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"1200","totalValueFC":"1211.8","currency":"USD","unitRateINR":"101820","date":"14-Oct-2024","totalValueINR":"101820","totalValueInUsd":"1211.8","indian_port":"Bombay Air","hs_no":"29337910","bill_no":"6105221","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"LTD XUNQIAO, LINHAI, ZHEJINAG 317024. CHINA CHINA","customerAddress":"304,ATLANTA ARCADE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744828200,"product":"BENAZEPRIL HYDROCHLORIDE USP BENAZEPRIL HYDROCHLORIDE USP","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"7.49","actualQuantity":"7.49","unit":"KGS","unitRateFc":"600","totalValueFC":"4546.4","currency":"USD","unitRateINR":"51960","date":"17-Apr-2025","totalValueINR":"389180.4","totalValueInUsd":"4546.4","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"9537681","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"XUNQIAO, LINHAI, ZHEJIANG, 317024, CHINA SDNF China","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744828200,"product":"BENAZEPRIL HYDROCHLORIDE USP BENAZEPRIL HYDROCHLORIDE USP","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"22.98","actualQuantity":"22.98","unit":"KGS","unitRateFc":"600","totalValueFC":"13948.8","currency":"USD","unitRateINR":"51960","date":"17-Apr-2025","totalValueINR":"1194040.8","totalValueInUsd":"13948.8","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"9537681","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"XUNQIAO, LINHAI, ZHEJIANG, 317024, CHINA SDNF China","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744828200,"product":"BENAZEPRIL HYDROCHLORIDE USP BENAZEPRIL HYDROCHLORIDE USP","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"88.00","actualQuantity":"88","unit":"KGS","unitRateFc":"600","totalValueFC":"53415.7","currency":"USD","unitRateINR":"51960","date":"17-Apr-2025","totalValueINR":"4572480","totalValueInUsd":"53415.7","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"9537681","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"XUNQIAO, LINHAI, ZHEJIANG, 317024, CHINA SDNF China","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744828200,"product":"BENAZEPRIL HYDROCHLORIDE USP BENAZEPRIL HYDROCHLORIDE USP","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"102.00","actualQuantity":"102","unit":"KGS","unitRateFc":"600","totalValueFC":"61913.7","currency":"USD","unitRateINR":"51960","date":"17-Apr-2025","totalValueINR":"5299920","totalValueInUsd":"61913.7","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"9537681","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"XUNQIAO, LINHAI, ZHEJIANG, 317024, CHINA SDNF China","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744828200,"product":"BENAZEPRIL HYDROCHLORIDE USP BENAZEPRIL HYDROCHLORIDE USP","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"173.14","actualQuantity":"173.14","unit":"KGS","unitRateFc":"600","totalValueFC":"105095.4","currency":"USD","unitRateINR":"51960","date":"17-Apr-2025","totalValueINR":"8996354.4","totalValueInUsd":"105095.4","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"9537681","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"XUNQIAO, LINHAI, ZHEJIANG, 317024, CHINA SDNF China","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"}]
    19-Jan-2021
    17-Apr-2025
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 10MG

    USFDA APPLICATION NUMBER - 19851

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    DOSAGE - TABLET;ORAL - 20MG

    USFDA APPLICATION NUMBER - 19851

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    DOSAGE - TABLET;ORAL - 40MG

    USFDA APPLICATION NUMBER - 19851

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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 - 19851

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    DOSAGE - CAPSULE;ORAL - EQ 10MG BASE;20MG

    USFDA APPLICATION NUMBER - 20364

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    DOSAGE - CAPSULE;ORAL - EQ 10MG BASE;40MG

    USFDA APPLICATION NUMBER - 20364

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    DOSAGE - CAPSULE;ORAL - EQ 2.5MG BASE;10MG

    USFDA APPLICATION NUMBER - 20364

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    DOSAGE - CAPSULE;ORAL - EQ 5MG BASE;10MG

    USFDA APPLICATION NUMBER - 20364

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    DOSAGE - CAPSULE;ORAL - EQ 5MG BASE;20MG

    USFDA APPLICATION NUMBER - 20364

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    DOSAGE - CAPSULE;ORAL - EQ 5MG BASE;40MG

    USFDA APPLICATION NUMBER - 20364

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    ABOUT THIS PAGE

    Looking for 86541-74-4 / Benazepril Hydrochloride API manufacturers, exporters & distributors?

    Benazepril Hydrochloride manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Benazepril Hydrochloride 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 Benazepril Hydrochloride manufacturer or Benazepril Hydrochloride supplier for your needs.

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

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

    API | Excipient name

    Benazepril Hydrochloride

    Synonyms

    86541-74-4, Benazepril hcl, Lotensin, Cibacen, Cibacene, Briem

    Cas Number

    86541-74-4

    Unique Ingredient Identifier (UNII)

    N1SN99T69T

    About Benazepril Hydrochloride

    Benazepril Hydrochloride is the hydrochloride salt of benazepril, a carboxyl-containing angiotensin-converting enzyme (ACE) inhibitor with antihypertensive activity. As a prodrug, benazepril is metabolized to its active form benazeprilat. Benazeprilat competitively binds to and inhibits ACE, thereby blocking the conversion of angiotensin I to angiotensin II. This prevents the potent vasoconstrictive actions of angiotensin II, resulting in vasodilation. Benazeprilat also decreases angiotensin II-induced aldosterone secretion by the adrenal cortex, which leads to an increase in sodium excretion and subsequently increases water outflow.

    Cibacene Manufacturers

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

    Cibacene Suppliers

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

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

    Cibacene USDMF

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

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

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

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

    Cibacene CEP

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

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

    Cibacene WC

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

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

    Cibacene 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 Cibacene as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Cibacene GMP

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

    Cibacene CoA

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

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

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