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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]

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REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"48.00","actualQuantity":"48","unit":"KGS","unitRateFc":"650","totalValueFC":"31545.1","currency":"USD","unitRateINR":"54697.5","date":"18-Oct-2023","totalValueINR":"2625480","totalValueInUsd":"31545.1","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"8356203","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"XUNQIAO, LINHAI, ZHEJIANG, 317024 CHINA ChinaSDNF China","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1697567400,"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":"SHANGHAI - PU DONG","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"138.00","actualQuantity":"138","unit":"KGS","unitRateFc":"650","totalValueFC":"90692.3","currency":"USD","unitRateINR":"54697.5","date":"18-Oct-2023","totalValueINR":"7548255","totalValueInUsd":"90692.3","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"8356203","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"XUNQIAO, LINHAI, ZHEJIANG, 317024 CHINA ChinaSDNF China","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1697567400,"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":"SHANGHAI - PU DONG","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"164.00","actualQuantity":"164","unit":"KGS","unitRateFc":"650","totalValueFC":"107779.2","currency":"USD","unitRateINR":"54697.5","date":"18-Oct-2023","totalValueINR":"8970390","totalValueInUsd":"107779.2","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"8356203","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"XUNQIAO, LINHAI, ZHEJIANG, 317024 CHINA ChinaSDNF China","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706207400,"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":"SHANGHAI - PU DONG","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"21.00","actualQuantity":"21","unit":"KGS","unitRateFc":"650","totalValueFC":"13812.3","currency":"USD","unitRateINR":"54665","date":"26-Jan-2024","totalValueINR":"1147965","totalValueInUsd":"13812.3","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"9839457","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"XUNQIAO, LINHAI, ZHEJIANG, 317024 CHINASDNF China","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706207400,"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":"SHANGHAI - PU DONG","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"84.00","actualQuantity":"84","unit":"KGS","unitRateFc":"650","totalValueFC":"55249.3","currency":"USD","unitRateINR":"54665","date":"26-Jan-2024","totalValueINR":"4591860","totalValueInUsd":"55249.3","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"9839457","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"XUNQIAO, LINHAI, ZHEJIANG, 317024 CHINASDNF China","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706207400,"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":"SHANGHAI - PU DONG","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"224.00","actualQuantity":"224","unit":"KGS","unitRateFc":"650","totalValueFC":"147331.4","currency":"USD","unitRateINR":"54665","date":"26-Jan-2024","totalValueINR":"12244960","totalValueInUsd":"147331.4","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"9839457","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"XUNQIAO, LINHAI, ZHEJIANG, 317024 CHINASDNF China","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706812200,"product":"BENAZEPRIL HYDROCHLORIDE (QTY: 1 X 1.2 GMS, VALUE: USD 117.15) (FOC)","address":"P.NO. 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D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706812200,"product":"BENAZEPRIL HYDROCHLORIDE (QTY: 1 X 125 MG, VALUE: USD 273) (FOC)","address":"P.NO. 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D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719340200,"product":"BENAZEPRIL HYDROCHLORIDE","address":"EOU R&D UNIT, M NO.1 A BLOCK,TEN","city":"TARAMANI CHENNAI,TAMIL NADU","supplier":"ZHEJIANG HUJAHAI PHARMACEUTICAL CO., LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"AXXELENT PHARMA SCIENCE ","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"1000","totalValueFC":"1009.8","currency":"USD","unitRateINR":"84300","date":"26-Jun-2024","totalValueINR":"84300","totalValueInUsd":"1009.8","indian_port":"Madras Air","hs_no":"29339990","bill_no":"4200031","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"XUNQIAO LINHAI ZHEJIANG 317024SDNFSDNF CHINA","customerAddress":"EOU R&D UNIT, M NO.1 A BLOCK,TEN"},{"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":"15.00","actualQuantity":"15","unit":"KGS","unitRateFc":"600","totalValueFC":"9104.2","currency":"USD","unitRateINR":"50910","date":"28-Aug-2024","totalValueINR":"763650","totalValueInUsd":"9104.2","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":"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":"45.00","actualQuantity":"45","unit":"KGS","unitRateFc":"600","totalValueFC":"27312.7","currency":"USD","unitRateINR":"50910","date":"28-Aug-2024","totalValueINR":"2290950","totalValueInUsd":"27312.7","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":"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. 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REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"184.00","actualQuantity":"184","unit":"KGS","unitRateFc":"600","totalValueFC":"111678.6","currency":"USD","unitRateINR":"50910","date":"28-Aug-2024","totalValueINR":"9367440","totalValueInUsd":"111678.6","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":1727893800,"product":"BENAZEPRIL HYDROCHLORIDE","address":"FLAT NO 305, TARA TOWERS, SALEEM NAGAR, MALAKPET, HEYDERABAD","city":"HYDERABAD","supplier":"ZHEJIANG HUAHAI PHARMACEUT CAL CO,LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"RITSA PHARMA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"850","totalValueFC":"85580.1","currency":"USD","unitRateINR":"71910","date":"03-Oct-2024","totalValueINR":"7191000","totalValueInUsd":"85580.1","indian_port":"Hyderabad Air","hs_no":"29182990","bill_no":"5931119","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"XUNQIAO,LINHAI,ZHEJIANG,317024 CHINA SDNF CN","customerAddress":"FLAT NO 305, TARA TOWERS, SALEEM NAGAR, MALAKPET, HEYDERABAD"},{"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 LTD","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,"}]
10-Feb-2021
16-Nov-2024
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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

Benazepril Hydrochloride Manufacturers

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

Benazepril Hydrochloride Suppliers

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

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

Benazepril Hydrochloride USDMF

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

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

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

Benazepril Hydrochloride CEP

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

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

Benazepril Hydrochloride WC

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

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

Benazepril 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 Benazepril Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Benazepril Hydrochloride GMP

Benazepril 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 Benazepril 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 Benazepril Hydrochloride GMP manufacturer or Benazepril Hydrochloride GMP API supplier for your needs.

Benazepril Hydrochloride CoA

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

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

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