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ACTIVE PHARMA INGREDIENTS

61 API Suppliers, 22 USDMF, 23 CEP/COS, 15 JDMF, 14 EU WC, 18 KDMF, 6 NDC API, 19 Listed Suppliers, $ API Reference Price

61 API Suppliers
22 USDMF
23 CEP/COS
15 JDMF
14 EU WC
18 KDMF
6 NDC API
19 Listed Suppliers
$ API Reference Price

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805 FDF Dossiers
51 FDA Orange Book
602 Europe
83 Canada
21 South Africa
48 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 16MG, TABLET;ORAL - 32MG, TABLET;ORAL - 4MG, TABLET;ORAL - 8MG, TABLET;ORAL - 16MG;12.5MG, TABLET;ORAL - 32MG;12.5MG, TABLET;ORAL - 32MG;25MG

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TABLET;ORAL - 16MG
TABLET;ORAL - 32MG
TABLET;ORAL - 4MG
TABLET;ORAL - 8MG
TABLET;ORAL - 16MG;12.5MG
TABLET;ORAL - 32MG;12.5MG
TABLET;ORAL - 32MG;25MG

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24 Direct Compression
16 Co-Processed Excipients
13 Chewable & Orodispersible Aids
12 Taste Masking
10 Parenteral
10 Granulation
9 Disintegrants & Superdisintegrants
9 Topical
8 Controlled & Modified Release
8 Lubricants & Glidants
8 Thickeners and Stabilizers
6 Solubilizers
6 Coating Systems & Additives
4 Film Formers & Plasticizers
1 API Stability Enhancers
1 Emulsifying Agents

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8 Health Canada Patents

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3 Analytical Methods

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Synopsis

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805

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602

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Listed Dossiers

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DRUG PRODUCT COMPOSITIONS

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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 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 Formula	C₃₃H₃₄N₆O₆
Molecular Weight	610.7 g/mol
XLogP3	7
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	10
Rotatable Bond Count	13
Exact Mass	610.25398283 g/mol
Monoisotopic Mass	610.25398283 g/mol
Topological Polar Surface Area	143 Å²
Heavy Atom Count	45
Formal Charge	0
Complexity	962
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	1
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 6
Drug Name	Atacand
PubMed Health	Candesartan (By mouth)
Drug Classes	Angiotensin II Receptor Antagonist/Thiazide Combination
Drug Label	ATACAND (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 Ingredient	Candesartan cilexetil
Dosage Form	Tablet
Route	Oral
Strength	32mg; 4mg; 16mg; 8mg
Market Status	Prescription
Company	Astrazeneca

2 of 6
Drug Name	Atacand hct
PubMed Health	Candesartan/Hydrochlorothiazide (By mouth)
Active Ingredient	hydrochlorothiazide; Candesartan cilexetil
Dosage Form	Tablet
Route	Oral
Strength	32mg; 25mg; 16mg; 12.5mg
Market Status	Prescription
Company	Astrazeneca

3 of 6
Drug Name	Candesartan cilexetil
Drug Label	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 described a...
Active Ingredient	Candesartan cilexetil
Dosage Form	Tablet
Route	oral; Oral
Strength	32mg; 4mg; 16mg; 8mg
Market Status	Tentative Approval; Prescription
Company	Matrix Labs; Apotex; Sandoz

4 of 6
Drug Name	Atacand
PubMed Health	Candesartan (By mouth)
Drug Classes	Angiotensin II Receptor Antagonist/Thiazide Combination
Drug Label	ATACAND (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 Ingredient	Candesartan cilexetil
Dosage Form	Tablet
Route	Oral
Strength	32mg; 4mg; 16mg; 8mg
Market Status	Prescription
Company	Astrazeneca

5 of 6
Drug Name	Atacand hct
PubMed Health	Candesartan/Hydrochlorothiazide (By mouth)
Active Ingredient	hydrochlorothiazide; Candesartan cilexetil
Dosage Form	Tablet
Route	Oral
Strength	32mg; 25mg; 16mg; 12.5mg
Market Status	Prescription
Company	Astrazeneca

6 of 6
Drug Name	Candesartan cilexetil
Drug Label	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 described a...
Active Ingredient	Candesartan cilexetil
Dosage Form	Tablet
Route	oral; Oral
Strength	32mg; 4mg; 16mg; 8mg
Market Status	Tentative Approval; Prescription
Company	Matrix 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

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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06

ULKAR KIMYA SANAYII VE TICARET

Turkey

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

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China

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Digital Content

USDMF

CEP/COS

JDMF

EU-WC NDC

KDMF

VMF Others AUDIT

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

09

Unimark Remedies Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

10

Lek Pharmaceuticals

Slovenia

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

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USDMF

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CEP/COS

01

TEVA PHARMACEUTICAL INDUSTRIES LTD ...

Israel

DCAT Week

Attending

TAPI offers customized CDMO Solutions for API development and manufacturing services.

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Israel

Virtual Booth

Digital Content

Candesartan Cilexetil, Form I - Process 2

Certificate Number : R0-CEP 2020-164 - Rev 01

Status : Valid

Issue Date : 2021-11-22

Type : Chemical

Substance Number : 2573

Product Web Link

02

TEVA PHARMACEUTICAL INDUSTRIES LTD ...

Israel

DCAT Week

Attending

TAPI offers customized CDMO Solutions for API development and manufacturing services.

Contact Supplier

Israel

Virtual Booth

Digital Content

Candesartan Cilexetil, Form I

Certificate Number : R1-CEP 2011-248 - Rev 02

Status : Valid

Issue Date : 2021-11-22

Type : Chemical

Substance Number : 2573

Product Web Link

03

AUROBINDO PHARMA LIMITED Hyderabad ...

PharmaVenue

Not Confirmed

09

DR. REDDY'S LABORATORIES LIMITED Hy...

Gabon

PharmaVenue

Not Confirmed

10

Zhejiang Kinglyuan Pharmaceutical C...

China

PharmaVenue

Not Confirmed

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JDMF

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EU WC

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KDMF

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NDC API

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Listed Suppliers

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API Reference Price

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Number of Transactions

Total Quantity (KGS)

Total Value (USD)

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

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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DOSAGE - TABLET;ORAL - 16MG

USFDA APPLICATION NUMBER - 20838

DOSAGE - TABLET;ORAL - 32MG

USFDA APPLICATION NUMBER - 20838

DOSAGE - TABLET;ORAL - 4MG

USFDA APPLICATION NUMBER - 20838

DOSAGE - TABLET;ORAL - 8MG

USFDA APPLICATION NUMBER - 20838

DOSAGE - TABLET;ORAL - 16MG;12.5MG

USFDA APPLICATION NUMBER - 21093

DOSAGE - TABLET;ORAL - 32MG;12.5MG

USFDA APPLICATION NUMBER - 21093

DOSAGE - TABLET;ORAL - 32MG;25MG

USFDA APPLICATION NUMBER - 21093

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ABOUT THIS PAGE

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.

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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.

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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).

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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.

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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.

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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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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

61 API Suppliers

22 USDMF

23 CEP/COS

15 JDMF

14 EU WC

18 KDMF

6 NDC API

19 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

INTERMEDIATES

22 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

805 FDF Dossiers

51 FDA Orange Book

602 Europe

83 Canada

21 South Africa

48 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 16MG

TABLET;ORAL - 32MG

TABLET;ORAL - 4MG

TABLET;ORAL - 8MG

TABLET;ORAL - 16MG;12.5MG

TABLET;ORAL - 32MG;12.5MG

TABLET;ORAL - 32MG;25MG

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EXCIPIENTS BY APPLICATIONS

63 Fillers, Diluents & Binders

24 Direct Compression

16 Co-Processed Excipients

13 Chewable & Orodispersible Aids

12 Taste Masking

10 Parenteral

10 Granulation

9 Disintegrants & Superdisintegrants

9 Topical

8 Controlled & Modified Release

8 Lubricants & Glidants

8 Thickeners and Stabilizers

6 Solubilizers

6 Coating Systems & Additives

4 Film Formers & Plasticizers

1 API Stability Enhancers