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    Chemistry

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    Also known as: 145040-37-5, Atacand, Tcv-116, Amias, Parapres, Kenzen
    Molecular Formula
    C33H34N6O6
    Molecular Weight
    610.7  g/mol
    InChI Key
    GHOSNRCGJFBJIB-UHFFFAOYSA-N
    FDA UNII
    R85M2X0D68
    Candesartan Cilexetil
    Candesartan Cilexetil is a synthetic, benzimidazole-derived angiotensin II receptor antagonist prodrug with antihypertensive activity. After hydrolysis of candesartan cilexetil to candesartan during gastrointestinal absorption, candesartan selectively competes with angiotensin II for the binding of the angiotensin II receptor subtype 1 (AT1) in vascular smooth muscle, blocking angiotensin II-mediated vasoconstriction and inducing vasodilatation. In addition, antagonism of AT1 in the adrenal gland inhibits angiotensin II-stimulated aldosterone synthesis and secretion by the adrenal cortex; sodium and water excretion increase, followed by a reduction in plasma volume and blood pressure.
    1 2D Structure

    Candesartan Cilexetil

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    1-cyclohexyloxycarbonyloxyethyl 2-ethoxy-3-[[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]methyl]benzimidazole-4-carboxylate
    2.1.2 InChI
    InChI=1S/C33H34N6O6/c1-3-42-32-34-28-15-9-14-27(31(40)43-21(2)44-33(41)45-24-10-5-4-6-11-24)29(28)39(32)20-22-16-18-23(19-17-22)25-12-7-8-13-26(25)30-35-37-38-36-30/h7-9,12-19,21,24H,3-6,10-11,20H2,1-2H3,(H,35,36,37,38)
    2.1.3 InChI Key
    GHOSNRCGJFBJIB-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CCOC1=NC2=CC=CC(=C2N1CC3=CC=C(C=C3)C4=CC=CC=C4C5=NNN=N5)C(=O)OC(C)OC(=O)OC6CCCCC6
    2.2 Other Identifiers
    2.2.1 UNII
    R85M2X0D68
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 1-(cyclohexylocarbonyloxy)ethyl-2-ethoxy-1-(2'-(1h-tetrazol-5-yl)biphenyl-4-yl)-1h-benzimidazole-7-carboxylate

    2. 1h-benzimidazolium, 7-carboxy-1-(2-((cyclohexylcarbonyl)oxy)ethyl)-2-ethoxy-1-(2'-(1h-tetrazol-5-yl)(1,1'-biphenyl)-4-yl)-, Hydroxide, Inner Salt, (+-)-

    3. Amias

    4. Atacand

    5. Blopress

    6. Kenzen

    7. Parapres

    8. Tcv 116

    9. Tcv-116

    2.3.2 Depositor-Supplied Synonyms

    1. 145040-37-5

    2. Atacand

    3. Tcv-116

    4. Amias

    5. Parapres

    6. Kenzen

    7. Candesartan Cilextil

    8. Tcv 116

    9. Candesartancilexetil

    10. Candesartan Cilexetil [usan]

    11. Nsc-758697

    12. Chembl1014

    13. Chebi:3348

    14. 1-(((cyclohexyloxy)carbonyl)oxy)ethyl 1-((2'-(2h-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-2-ethoxy-1h-benzo[d]imidazole-7-carboxylate

    15. R85m2x0d68

    16. 1-(cyclohexyloxycarbonyloxy)ethyl 1-((2'-(1h-tetrazol-5-yl)biphenyl-4-yl)methyl)-2-ethoxy-1h-benzo[d]imidazole-7-carboxylate

    17. 1-cyclohexyloxycarbonyloxyethyl 2-ethoxy-3-[[4-[2-(2h-tetrazol-5-yl)phenyl]phenyl]methyl]benzimidazole-4-carboxylate

    18. 1-(((cyclohexyloxy)carbonyl)oxy)ethyl 1-((2'-(1h-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-2-ethoxy-1h-benzo[d]imidazole-7-carboxylate

    19. Candesartan 1-(((cyclohexyloxy)carbonyl)oxy)ethyl Ester

    20. Candesartan 1-[[(cyclohexyloxy)carbonyl]oxy]ethyl Ester

    21. Racanda

    22. Unii-r85m2x0d68

    23. Tcy 116

    24. Candesartan Hexetil

    25. 1-cyclohexyloxycarbonyloxyethyl 2-ethoxy-3-[[4-[2-(1h-tetrazol-5-yl)phenyl]phenyl]methyl]benzimidazole-4-carboxylate

    26. Atacand (tn)

    27. Candesartan Cilexitil

    28. Mfcd00871371

    29. Spectrum_001707

    30. Candesartan (cilexetil)

    31. Dsstox_cid_239

    32. Spectrum2_000485

    33. Spectrum3_000996

    34. Spectrum4_001124

    35. Spectrum5_001462

    36. Candesartan Celexetil Ester

    37. Dsstox_rid_85567

    38. Dsstox_gsid_20239

    39. Schembl40831

    40. Bspbio_002691

    41. Candesartan Cilexetil- Bio-x

    42. Kbiogr_001607

    43. Kbioss_002187

    44. 1h-benzimidazolium, 7-carboxy-1-(2-((cyclohexylcarbonyl)oxy)ethyl)-2-ethoxy-1-(2'-(1h-tetrazol-5-yl)(1,1'-biphenyl)-4-yl)-, Hydroxide, Inner Salt, (+-)-

    45. Candesartan Cilexetil-[d11]

    46. Mls004774127

    47. Candesartan Cilexetil , 97%

    48. Spectrum1504261

    49. Spbio_000349

    50. Gtpl8352

    51. Candesartan Cilexetil (atacand)

    52. Dtxsid5020239

    53. Kbio2_002187

    54. Kbio2_004755

    55. Kbio2_007323

    56. Kbio3_001911

    57. Hms1922j09

    58. Hms2093e20

    59. Hms3651i08

    60. Pharmakon1600-01504261

    61. Candesartan Cilexetil (jp17/usp)

    62. Candesartan Cilexetil [jan]

    63. Bcp22050

    64. Tox21_302202

    65. Ac-204

    66. Bdbm50318907

    67. Candesartan Cilexetil [vandf]

    68. Ccg-39530

    69. Nsc758697

    70. S2037

    71. Stl451065

    72. Candesartan Cilexetil [mart.]

    73. Akos015894954

    74. Akos015920180

    75. Candesartan Cilexetil [usp-rs]

    76. Candesartan Cilexetil [who-dd]

    77. Ab07617

    78. Am90293

    79. Bcp9000480

    80. Ccg-222334

    81. Db00796

    82. Ds-1302

    83. Ks-1147

    84. Nsc 758697

    85. Candesartan Cilexetil, >=98% (hplc)

    86. Ncgc00095123-01

    87. Ncgc00095123-02

    88. Ncgc00095123-03

    89. Ncgc00095123-05

    90. Ncgc00095123-10

    91. Ncgc00095123-16

    92. Ncgc00255218-01

    93. (+-)-1-hydroxyethyl 2-ethoxy-1-(p-(o-1h-tetrazol-5-ylphenyl)benzyl)-7-benzimidazolecarboxylate, Cyclohexyl Carbonate (ester)

    94. 1-[[(cyclohexyloxy)carbonyl]oxy]ethyl 2-ethoxy-1-[[2'-(1h-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1h-benzimidazole-7-carboxylate

    95. 1-{[(cyclohexyloxy)carbonyl]oxy}ethyl 2-(ethyloxy)-1-{[2'-(1h-tetrazol-5-yl)biphenyl-4-yl]methyl}-1h-benzimidazole-7-carboxylate

    96. 1h-benzimidazole-7-carboxylic Acid, 2-ethoxy-1-((2'-(1h-tetrazol-5-yl)(1,1'-biphenyl)-4-yl)methyl)-, 1-(((cyclohexyloxy)carbonyl)oxy)ethyl Ester, (+-)-

    97. 2-ethoxy-1-[[2'-(2h-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1h-benzimidazole-7-carboxylic Acid 1-[[(cyclohexyloxy)carbonyl]oxy]ethyl Ester

    98. 2-ethoxy-3-[2'-(1h-tetrazol-5-yl)-biphenyl-4-ylmethyl]-3h-benzoimidazole-4-carboxylic Acid 1-cyclohexyloxycarbonyloxy-ethyl Ester

    99. Bc164274

    100. Hy-17505

    101. Smr003500784

    102. Candesartan Cilexetil [orange Book]

    103. Sbi-0206767.p001

    104. Candesartan Cilexetil [ep Monograph]

    105. Candesartan Cilexetil [usp Monograph]

    106. Cas-145040-37-5

    107. Ft-0602914

    108. Sw220041-1

    109. C07709

    110. D00626

    111. Ab01274805-01

    112. Ab01274805_02

    113. Ab01274805_03

    114. 040c375

    115. H212/91

    116. L006257

    117. Sr-05000001976

    118. Camptothecine, Antibiotic For Culture Media Use Only

    119. Q-200786

    120. Sr-05000001976-1

    121. Brd-a65671304-001-02-6

    122. Brd-a65671304-001-03-4

    123. Q27075664

    124. Candesartan 1-(((cyclohexyloxy)carbonyl)oxy)ethyl Ester [mi]

    125. Candesartan Cilexetil, European Pharmacopoeia (ep) Reference Standard

    126. Candesartan Cilexetil, United States Pharmacopeia (usp) Reference Standard

    127. Candesartan Cilexetil For Peak Identification, European Pharmacopoeia (ep) Reference Standard

    128. Candesartan Cilexetil For System Suitability, European Pharmacopoeia (ep) Reference Standard

    129. Candesartan Cilexetil, Pharmaceutical Secondary Standard; Certified Reference Material

    130. (+/-)-1-(cyclohexyloxycarbonyloxy)ethyl 2-ethoxy-1-[2'-(1h-tetrazol-5-yl) Biphenyl-4-yl]methylbenzimidazole-7-carboxylate

    131. (+/-)-1-(cyclohexyloxycarbonyloxy)ethyl 2-ethoxy-1-[2'-(1h-tetrazol-5-yl)biphenyl-4-yl]methylbenzimidazole-7-carboxylate

    132. (+/-)1-hydroxyethyl 2-ethoxy-1-(p-(o-1h-tetrazol-5-ylphenyl)benzyl)-7-benzimidazolecarboxylate, Cyclohexyl Carbonate (ester)

    133. 1-(((cyclohexyloxy)carbonyl)oxy)ethyl1-((2'-(2h-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-2-ethoxy-1h-benzo[d]imidazole-7-carboxylate

    134. 1-(cyclohexyloxycarbonyloxy)ethyl-2-ethoxy-1-[[2'-(1h-tetrazol-5-yl)biphenyl-4-yl]methyl]benzimidazol-7-carboxylate

    135. 1-{[(cyclohexyloxy)carbonyl]oxy}ethyl 2-ethoxy-1-{[2'-(1h-tetrazol-5-yl)biphenyl-4-yl]methyl}-1h-benzimidazole-7-carboxylate

    136. 1-cyclohexyloxycarbonyloxyethyl 2-ethoxy-3-[[4-[2-(2h-tetrazol-5-yl)phenyl]phenyl] Methyl]benzimidazole-4-carboxylate

    137. 1-cyclohexyloxycarbonyloxyethyl 2-ethoxy-3-[[4-[2-(2h-tetrazol-5-yl)phenyl]phenyl]methyl]benzimidazole-4-carboxylate.

    138. 1h-benzimidazole-7-carboxylic Acid, 2-ethoxy-1-((2'-(1h-tetrazol-5-yl)(1,1'-biphenyl)-4-yl)methyl)-, 1-(((cyclohexyloxy)carbonyl)oxy)ethyl Ester, (+/-)-

    139. 1h-benzimidazole-7-carboxylic Acid, 2-ethoxy-1-[[2'-(2h-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-, 1-[[(cyclohexyloxy)carbonyl]oxy]ethyl Ester

    140. 2-ethoxy-1-[2'-(1h-tetrazole-5-yl)-4-biphenylylmethyl]-1h-benzimidazole-7-carboxylic Acid 1-(cyclohexyloxycarbonyloxy)ethyl Ester

    141. 2-ethoxy-3-[2''-(1h-tetrazol-5-yl)-biphenyl-4-ylmethyl]-3h-benzoimidazole-4-carboxylic Acid 1-cyclohexyloxycarbonyloxy-ethyl Ester

    142. 2-ethoxy-3-[2''-(2h-tetrazol-5-yl)-biphenyl-4-ylmethyl]-3h-benzoimidazole-4-carboxylic Acid 1-cyclohexyloxycarbonyloxy-ethyl Ester

    143. 2-ethoxy-3-[2'-(1h-tetrazol-5-yl)-biphenyl-4-ylmethyl]-3h-benzoimidazole-4-carboxylic Acid 1-cyclohe

    2.4 Create Date
    2005-03-25
    3 Chemical and Physical Properties
    Molecular Weight 610.7 g/mol
    Molecular Formula C33H34N6O6
    XLogP37
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count10
    Rotatable Bond Count13
    Exact Mass610.25398283 g/mol
    Monoisotopic Mass610.25398283 g/mol
    Topological Polar Surface Area143 Ų
    Heavy Atom Count45
    Formal Charge0
    Complexity962
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 6  
    Drug NameAtacand
    PubMed HealthCandesartan (By mouth)
    Drug ClassesAngiotensin II Receptor Antagonist/Thiazide Combination
    Drug LabelATACAND (candesartan cilexetil), a prodrug, is hydrolyzed to candesartan during absorption from the gastrointestinal tract. Candesartan is a selective AT1 subtype angiotensin II receptor antagonist.Candesartan cilexetil, a nonpeptide, is chemically d...
    Active IngredientCandesartan cilexetil
    Dosage FormTablet
    RouteOral
    Strength32mg; 4mg; 16mg; 8mg
    Market StatusPrescription
    CompanyAstrazeneca

    2 of 6  
    Drug NameAtacand hct
    PubMed HealthCandesartan/Hydrochlorothiazide (By mouth)
    Active Ingredienthydrochlorothiazide; Candesartan cilexetil
    Dosage FormTablet
    RouteOral
    Strength32mg; 25mg; 16mg; 12.5mg
    Market StatusPrescription
    CompanyAstrazeneca

    3 of 6  
    Drug NameCandesartan cilexetil
    Drug LabelCandesartan cilexetil, a prodrug, is hydrolyzed to candesartan during absorption from the gastrointestinal tract. Candesartan is a selective AT1 subtype angiotensin II receptor antagonist.Candesartan cilexetil, a nonpeptide, is chemically described a...
    Active IngredientCandesartan cilexetil
    Dosage FormTablet
    Routeoral; Oral
    Strength32mg; 4mg; 16mg; 8mg
    Market StatusTentative Approval; Prescription
    CompanyMatrix Labs; Apotex; Sandoz

    4 of 6  
    Drug NameAtacand
    PubMed HealthCandesartan (By mouth)
    Drug ClassesAngiotensin II Receptor Antagonist/Thiazide Combination
    Drug LabelATACAND (candesartan cilexetil), a prodrug, is hydrolyzed to candesartan during absorption from the gastrointestinal tract. Candesartan is a selective AT1 subtype angiotensin II receptor antagonist.Candesartan cilexetil, a nonpeptide, is chemically d...
    Active IngredientCandesartan cilexetil
    Dosage FormTablet
    RouteOral
    Strength32mg; 4mg; 16mg; 8mg
    Market StatusPrescription
    CompanyAstrazeneca

    5 of 6  
    Drug NameAtacand hct
    PubMed HealthCandesartan/Hydrochlorothiazide (By mouth)
    Active Ingredienthydrochlorothiazide; Candesartan cilexetil
    Dosage FormTablet
    RouteOral
    Strength32mg; 25mg; 16mg; 12.5mg
    Market StatusPrescription
    CompanyAstrazeneca

    6 of 6  
    Drug NameCandesartan cilexetil
    Drug LabelCandesartan cilexetil, a prodrug, is hydrolyzed to candesartan during absorption from the gastrointestinal tract. Candesartan is a selective AT1 subtype angiotensin II receptor antagonist.Candesartan cilexetil, a nonpeptide, is chemically described a...
    Active IngredientCandesartan cilexetil
    Dosage FormTablet
    Routeoral; Oral
    Strength32mg; 4mg; 16mg; 8mg
    Market StatusTentative Approval; Prescription
    CompanyMatrix Labs; Apotex; Sandoz

    4.2 Drug Indication

    May be used as a first line agent to treat uncomplicated hypertension, isolated systolic hypertension and left ventricular hypertrophy. May be used as a first line agent to delay progression of diabetic nephropathy. Candesartan may be also used as a second line agent in the treatment of congestive heart failure, systolic dysfunction, myocardial infarction and coronary artery disease in those intolerant of ACE inhibitors.

    FDA Label

    Diabetic retinopathy, Essential hypertension, Heart Failure

    Diabetic retinopathy, Essential hypertension, Heart Failure

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Candesartan cilexetil is an ARB prodrug that is rapidly converted to candesartan, its active metabolite, during absorption from the gastrointestinal tract. Candesartan confers blood pressure lowering effects by antagonizing the hypertensive effects of angiotensin II via the RAAS. RAAS is a homeostatic mechanism for regulating hemodynamics, water and electrolyte balance. During sympathetic stimulation or when renal blood pressure or blood flow is reduced, renin is released from granular cells of the juxtaglomerular apparatus in the kidneys. Renin cleaves circulating angiotensinogen to angiotensin I, which is cleaved by angiotensin converting enzyme (ACE) to angiotensin II. Angiotensin II increases blood pressure by increasing total peripheral resistance, increasing sodium and water reabsorption in the kidneys via aldosterone secretion, and altering cardiovascular structure. Angiotensin II binds to two receptors: type-1 angiotensin II receptor (AT1) and type-2 angiotensin II receptor (AT2). AT1 is a G-protein coupled receptor (GPCR) that mediates the vasoconstrictive and aldosterone-secreting effects of angiotensin II. Studies performed in recent years suggest that AT2 antagonizes AT1-mediated effects and directly affects long-term blood pressure control by inducing vasorelaxation and increasing urinary sodium excretion. Angiotensin receptor blockers (ARBs) are non-peptide competitive inhibitors of AT1. ARBs block the ability of angiotensin II to stimulate pressor and cell proliferative effects. Unlike ACE inhibitors, ARBs do not affect bradykinin-induced vasodilation. The overall effect of ARBs is a decrease in blood pressure.

    5.2 MeSH Pharmacological Classification

    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.)

    Angiotensin II Type 1 Receptor Blockers

    Agents that antagonize ANGIOTENSIN II TYPE 1 RECEPTOR. Included are ANGIOTENSIN II analogs such as SARALASIN and biphenylimidazoles such as LOSARTAN. Some are used as ANTIHYPERTENSIVE AGENTS. (See all compounds classified as Angiotensin II Type 1 Receptor Blockers.)

    5.3 FDA Pharmacological Classification
    5.3.1 Pharmacological Classes
    Angiotensin 2 Receptor Blocker [EPC]; Angiotensin 2 Receptor Antagonists [MoA]
    5.4 Absorption, Distribution and Excretion

    Absorption

    Following administration of the candesartan cilexetil prodrug, the absolute bioavailability of candesartan was estimated to be 15%. Food with a high fat content has no effect on the bioavailability of candesartan from candesartan cilexetil.

    Route of Elimination

    When candesartan is administered orally, about 26% of the dose is excreted unchanged in urine. Candesartan is mainly excreted unchanged in urine and feces (via bile).

    Volume of Distribution

    0.13 L/kg

    Clearance

    0.37 mL/min/kg

    5.5 Metabolism/Metabolites

    The prodrug candesartan cilexetil undergoes rapid and complete ester hydrolysis in the intestinal wall to form the active drug, candesartan. Elimination of candesartan is primarily as unchanged drug in the urine and, by the biliary route, in the feces. Minor hepatic metabolism of candesartan (<20%) occurs by O-deethylation via cytochrome P450 2C9 to form an inactive metabolite. Candesartan undergoes N-glucuronidation in the tetrazole ring by uridine diphosphate glucuronosyltransferase 1A3 (UGT1A3). O-glucuronidation may also occur. 75% of candesartan is excreted as unchanged drug in urine and feces.

    5.6 Biological Half-Life

    Approximately 9 hours.

    5.7 Mechanism of Action

    Candesartan selectively blocks the binding of angiotensin II to AT1 in many tissues including vascular smooth muscle and the adrenal glands. This inhibits the AT1-mediated vasoconstrictive and aldosterone-secreting effects of angiotensin II and results in an overall decrease in blood pressure. Candesartan is greater than 10,000 times more selective for AT1 than AT2. Inhibition of aldosterone secretion may increase sodium and water excretion while decreasing potassium excretion.

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LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"SCOTT-EDIL PHARMACIA","customerCountry":"INDIA","quantity":"135.00","actualQuantity":"135","unit":"KGS","unitRateFc":"348","totalValueFC":"50546.2","currency":"USD","unitRateINR":"31596.3","date":"04-Nov-2024","totalValueINR":"4265505.51","totalValueInUsd":"50546.2","indian_port":"Delhi Air","hs_no":"29339990","bill_no":"6494894","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"SUITE 27G WORLD PLAZA 855 SOUTH PUDONG ROAD PUDONG SHANGHAI SDNF CHINA","customerAddress":"PLOT NO 54 AND 55 INDUSTRIAL AREA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730745000,"product":"CANDESARTAN CILEXETIL- CANDESARTAN CILEXETIL","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"VIATRIS","customerCountry":"INDIA","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"475","totalValueFC":"239081.2","currency":"USD","unitRateINR":"40351.3","date":"05-Nov-2024","totalValueINR":"20175625","totalValueInUsd":"239081.2","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"6507632","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"XUNQIAO LINHAI, ZHEJIANG 317024 Chi na SDNF China","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1735756200,"product":"CANDESARTAN CILEXETIL USPB NO.5712-24-433,5712-24-373","address":"98, GOVT.INDUSTRIAL AREA,","city":"MUMBAI.","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"HANGZHOU","customer":"AJANTA PHARMA LIMITED","customerCountry":"INDIA","quantity":"30.00","actualQuantity":"30","unit":"KGS","unitRateFc":"750","totalValueFC":"22427.1","currency":"USD","unitRateINR":"64462.5","date":"02-Jan-2025","totalValueINR":"1933875","totalValueInUsd":"22427.1","indian_port":"Dahez-SEZ","hs_no":"29339990","bill_no":"7578015","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGZHOU","supplierAddress":"XUNQIAO, LINHAI ZHEJIANG CHINA 317024 SDNF China","customerAddress":"98, GOVT.INDUSTRIAL AREA,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1736361000,"product":"CANDESARTAN CILEXETIL PH. 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    05-Jan-2021
    20-Jan-2025
    KGS
    overview
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    Average Price (USD/KGS)

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    Total Quantity (KGS)

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    Quantity (KGS) & Unit rate (USD/KGS) over time

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    API Imports and Exports

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    (KGS)    		 Average Price
    (USD/KGS)    		 Number of Transactions

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    01

    ANI PHARMS

    U.S.A
    European Pharma Congress
    Not Confirmed
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    ANI PHARMS

    U.S.A
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    European Pharma Congress
    Not Confirmed
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    RLD : Yes

    TE Code : AB

    CANDESARTAN CILEXETIL

    Brand Name : ATACAND

    Dosage Form : TABLET;ORAL

    Dosage Strength : 16MG

    Approval Date : 1998-06-04

    Application Number : 20838

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    02

    ANI PHARMS

    U.S.A
    European Pharma Congress
    Not Confirmed
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    ANI PHARMS

    U.S.A
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    European Pharma Congress
    Not Confirmed
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    Digital Content Digital Content

    RLD : Yes

    TE Code : AB

    CANDESARTAN CILEXETIL

    Brand Name : ATACAND

    Dosage Form : TABLET;ORAL

    Dosage Strength : 32MG

    Approval Date : 1998-06-04

    Application Number : 20838

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    03

    APOTEX INC

    Canada
    European Pharma Congress
    Not Confirmed
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    APOTEX INC

    Canada
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    European Pharma Congress
    Not Confirmed
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    Digital Content Digital Content

    RLD : No

    TE Code :

    CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

    Brand Name : CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 32MG;25MG

    Approval Date : 2013-06-03

    Application Number : 202884

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    04

    MACLEODS PHARMS LTD

    India
    European Pharma Congress
    Not Confirmed
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    MACLEODS PHARMS LTD

    India
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    European Pharma Congress
    Not Confirmed
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    Digital Content Digital Content

    RLD : No

    TE Code : AB

    CANDESARTAN CILEXETIL

    Brand Name : CANDESARTAN CILEXETIL

    Dosage Form : TABLET;ORAL

    Dosage Strength : 8MG

    Approval Date : 2016-12-05

    Application Number : 203813

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    05

    MACLEODS PHARMS LTD

    India
    European Pharma Congress
    Not Confirmed
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    MACLEODS PHARMS LTD

    India
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    European Pharma Congress
    Not Confirmed
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    Flag India
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    Digital Content Digital Content

    RLD : No

    TE Code : AB

    CANDESARTAN CILEXETIL

    Brand Name : CANDESARTAN CILEXETIL

    Dosage Form : TABLET;ORAL

    Dosage Strength : 16MG

    Approval Date : 2016-12-05

    Application Number : 203813

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    RLD : No

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    CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

    Brand Name : CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 16MG;12.5MG

    Approval Date : 2018-04-11

    Application Number : 207455

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    RLD :

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    CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

    Brand Name : CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

    Dosage Form : TABLET; ORAL

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    Approval Date :

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    CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

    Brand Name : CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

    Dosage Form : TABLET; ORAL

    Dosage Strength : 32MG; 12.5MG

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    RLD : No

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    CANDESARTAN CILEXETIL

    Brand Name : CANDESARTAN CILEXETIL

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    Dosage Strength : 32MG

    Approval Date : 2013-05-03

    Application Number : 78702

    RX/OTC/DISCN : RX

    RLD : No

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    RLD : No

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    CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

    Brand Name : CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 16MG;12.5MG

    Approval Date : 2012-12-04

    Application Number : 90704

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Europe

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    Candesartanum cilexetilum

    Brand Name : Candesartan Zentiva

    Dosage Form : Tablet

    Dosage Strength : 16mg

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    Candesartanum cilexetilum

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    Candesartanum cilexetilum

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    Candesartanum cilexetilum

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    Candesartanum cilexetilum; Hydrochlorothiazidum

    Brand Name : Candesartan HCT Zentiva

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    Dosage Strength : 16/12.5mg

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    Candesartanum cilexetilum; Hydrochlorothiazidum

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    Candesartanum cilexetilum; Hydrochlorothiazidum

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 16MG

    USFDA APPLICATION NUMBER - 20838

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    DOSAGE - TABLET;ORAL - 32MG

    USFDA APPLICATION NUMBER - 20838

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    DOSAGE - TABLET;ORAL - 4MG

    USFDA APPLICATION NUMBER - 20838

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    DOSAGE - TABLET;ORAL - 8MG

    USFDA APPLICATION NUMBER - 20838

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    DOSAGE - TABLET;ORAL - 16MG;12.5MG

    USFDA APPLICATION NUMBER - 21093

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    DOSAGE - TABLET;ORAL - 32MG;12.5MG

    USFDA APPLICATION NUMBER - 21093

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    DOSAGE - TABLET;ORAL - 32MG;25MG

    USFDA APPLICATION NUMBER - 21093

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    ABOUT THIS PAGE

    Looking for 145040-37-5 / Candesartan Cilexetil API manufacturers, exporters & distributors?

    Candesartan Cilexetil manufacturers, exporters & distributors 1

    32

    PharmaCompass offers a list of Candesartan Cilexetil 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 Candesartan Cilexetil manufacturer or Candesartan Cilexetil supplier for your needs.

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

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

    API | Excipient name

    Candesartan Cilexetil

    Synonyms

    145040-37-5, Atacand, Tcv-116, Amias, Parapres, Kenzen

    Cas Number

    145040-37-5

    Unique Ingredient Identifier (UNII)

    R85M2X0D68

    About Candesartan Cilexetil

    Candesartan Cilexetil is a synthetic, benzimidazole-derived angiotensin II receptor antagonist prodrug with antihypertensive activity. After hydrolysis of candesartan cilexetil to candesartan during gastrointestinal absorption, candesartan selectively competes with angiotensin II for the binding of the angiotensin II receptor subtype 1 (AT1) in vascular smooth muscle, blocking angiotensin II-mediated vasoconstriction and inducing vasodilatation. In addition, antagonism of AT1 in the adrenal gland inhibits angiotensin II-stimulated aldosterone synthesis and secretion by the adrenal cortex; sodium and water excretion increase, followed by a reduction in plasma volume and blood pressure.

    Candesartan Cilexetil Manufacturers

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

    Candesartan Cilexetil Suppliers

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

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

    Candesartan Cilexetil USDMF

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

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

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

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

    Candesartan Cilexetil KDMF

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

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

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

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

    Candesartan Cilexetil CEP

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

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

    Candesartan Cilexetil WC

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

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

    Candesartan Cilexetil 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 Candesartan Cilexetil as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Candesartan Cilexetil GMP

    Candesartan Cilexetil 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 Candesartan Cilexetil 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 Candesartan Cilexetil GMP manufacturer or Candesartan Cilexetil GMP API supplier for your needs.

    Candesartan Cilexetil CoA

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

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

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