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Chemistry

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Also known as: 144689-63-4, Benicar, Olmetec, Cs-866, Cs 866, Nsc-758924
Molecular Formula
C29H30N6O6
Molecular Weight
558.6  g/mol
InChI Key
UQGKUQLKSCSZGY-UHFFFAOYSA-N
FDA UNII
6M97XTV3HD

Olmesartan Medoxomil
An ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKER that is used to manage HYPERTENSION.
1 2D Structure

Olmesartan Medoxomil

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 5-(2-hydroxypropan-2-yl)-2-propyl-3-[[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]methyl]imidazole-4-carboxylate
2.1.2 InChI
InChI=1S/C29H30N6O6/c1-5-8-23-30-25(29(3,4)38)24(27(36)39-16-22-17(2)40-28(37)41-22)35(23)15-18-11-13-19(14-12-18)20-9-6-7-10-21(20)26-31-33-34-32-26/h6-7,9-14,38H,5,8,15-16H2,1-4H3,(H,31,32,33,34)
2.1.3 InChI Key
UQGKUQLKSCSZGY-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CCCC1=NC(=C(N1CC2=CC=C(C=C2)C3=CC=CC=C3C4=NNN=N4)C(=O)OCC5=C(OC(=O)O5)C)C(C)(C)O
2.2 Other Identifiers
2.2.1 UNII
6M97XTV3HD
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 5-methyl-2-oxo-1,3-dioxolen-4-yl)methoxy-4-(1-hydroxy-1-methylethyl)-2-propyl-1-(4-(2-(tetrazol-5-yl)phenyl)phenyl)methylimidazol-5-carboxylate - T287346

2. Benicar

3. Cs 866

4. Cs-866

5. Cs866

6. Medoxomil, Olmesartan

7. Olmetec

8. Votum

2.3.2 Depositor-Supplied Synonyms

1. 144689-63-4

2. Benicar

3. Olmetec

4. Cs-866

5. Cs 866

6. Nsc-758924

7. 6m97xtv3hd

8. (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 5-(2-hydroxypropan-2-yl)-2-propyl-3-[[4-[2-(2h-tetrazol-5-yl)phenyl]phenyl]methyl]imidazole-4-carboxylate

9. 1h-imidazole-5-carboxylic Acid, 4-(1-hydroxy-1-methylethyl)-2-propyl-1-((2'-(1h-tetrazol-5-yl)(1,1'-biphenyl)-4-yl)methyl)-, (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl Ester

10. Ncgc00095136-01

11. Benevas

12. Olsertain

13. Olvance

14. (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 1-((2'-(1h-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-4-(2-hydroxypropan-2-yl)-2-propyl-1h-imidazole-5-carboxylate

15. (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 1-((2'-(1h-tetrazol-5-yl)-[1,1'-biphenyl]4-yl)methyl)-4-(2-hydroxypropan-2-yl)-2-propyl-1h-imidazole-5-carboxylate

16. (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 1-((2'-(2h-tetrazol-5-yl)biphenyl-4-yl)methyl)-4-(2-hydroxypropan-2-yl)-2-propyl-1h-imidazole-5-carboxylate

17. Benicar (tn)

18. Olmetec (tn)

19. Cs866

20. Sr-05000001987

21. Unii-6m97xtv3hd

22. Votume

23. Openvas

24. Cs-866dm

25. Cs-866rn

26. Olmesartanmedoxomil

27. Olmesartan-medoxomil

28. (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 5-(2-hydroxypropan-2-yl)-2-propyl-3-[[4-[2-(1h-tetrazol-5-yl)phenyl]phenyl]methyl]imidazole-4-carboxylate

29. Olmesartan Medoxomil [usan:inn:ban]

30. Ks-1182

31. Olmesartan (medoxomil)

32. Spectrum_001944

33. Spectrum2_000506

34. Spectrum3_001676

35. Spectrum4_000740

36. Spectrum5_001556

37. Dsstox_cid_25924

38. Dsstox_rid_81226

39. Dsstox_gsid_45924

40. Schembl16403

41. Bspbio_003491

42. Gtpl591

43. Kbiogr_001040

44. Kbioss_002498

45. 1h-imidazole-5-carboxylic Acid, 4-(1-hydroxy-1-methylethyl)-2-propyl-1-((2'-(1h-tetrazol-5-yl) (1,1'-biphenyl)-4-yl)methyl)-, (5-methyl-2-oxo-1,3-dioxol-4-yl) Methyl Ester

46. Mls006010109

47. Spectrum1505205

48. Spbio_000431

49. Olmesartan Medoxomil (benicar)

50. Chembl1200692

51. Dtxsid9045924

52. Chebi:31932

53. Kbio2_002490

54. Kbio2_005058

55. Kbio2_007626

56. Kbio3_002711

57. Hms1922l15

58. Hms2089k18

59. Hms2093k16

60. Hms3651e13

61. Hms3715n09

62. Hms3743o09

63. Olmesartan Medoxomil (jp17/usp)

64. Olmesartan Medoxomil [inn]

65. Olmesartan Medoxomil [jan]

66. Pharmakon1600-01505205

67. Olmesartan Medoxomil [usan]

68. Amy22222

69. Bcp05214

70. Zinc4149248

71. Olmesartan Medoxomil [vandf]

72. Tox21_111445

73. Bdbm50442892

74. Ccg-39596

75. Mfcd00944911

76. Nsc758924

77. Olmesartan Medoxomil [mart.]

78. S1604

79. Stl451024

80. Olmesartan Medoxomil [usp-rs]

81. Olmesartan Medoxomil [who-dd]

82. Akos015894907

83. Akos015914772

84. Ac-1601

85. Bcp9000555

86. Ccg-221184

87. Cs-0577

88. Nsc 758924

89. Olmesartan Medoxomil, >=98% (hplc)

90. Sb19327

91. Ncgc00095136-02

92. Ncgc00095136-03

93. Ncgc00095136-09

94. (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 1-((2'-(2h-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-4-(2-hydroxypropan-2-yl)-2-propyl-1h-imidazole-5-carboxylate

95. Azor Component Olmesartan Medoxomil

96. Hy-17005

97. Olmesartan Medoxomil [orange Book]

98. Smr002203616

99. Olmesartan Medoxomil [ep Monograph]

100. Sbi-0206741.p001

101. Olmesartan Medoxomil [usp Monograph]

102. Cas-144689-63-4

103. Ft-0601603

104. O0510

105. Olmesartan Medoxomil Component Of Azor

106. Sw199650-2

107. D01204

108. Tribenzor Component Olmesartan Medoxomil

109. Ab01275443-01

110. Ab01275443_02

111. Ab01275443_03

112. Benicar Hct Component Olmesartan Medoxomil

113. 689o634

114. A808260

115. L001061

116. Olmesartan Medoxomil Component Of Tribenzor

117. J-501595

118. Olmesartan Medoxomil Component Of Benicar Hct

119. Sr-05000001987-1

120. Sr-05000001987-2

121. Brd-k78485176-001-02-9

122. Brd-k78485176-001-03-7

123. Q27888058

124. Z1550675457

125. Olmesartan Medoxomil, European Pharmacopoeia (ep) Reference Standard

126. Olmesartan Medoxomil, United States Pharmacopeia (usp) Reference Standard

127. Olmesartan Medoxomil For System Suitability, European Pharmacopoeia (ep) Reference Standard

128. Olmesartan Medoxomil, Pharmaceutical Secondary Standard; Certified Reference Material

129. (5-methyl-2-oxidanylidene-1,3-dioxol-4-yl)methyl 5-(2-oxidanylpropan-2-yl)-2-propyl-3-[[4-[2-(2h-1,2,3,4-tetrazol-5-yl)phenyl]phenyl]methyl]imidazole-4-carboxylate

130. (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 1-((2'-(1h-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-4-(2-hydroxypropan-2-yl)-2-propyl-1h-i Midazole-5-carboxylate

131. (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 1-((2'-(1h-tetrazol-5-yl)biphenyl-4-yl)methyl)-4-(2-hydroxypropan-2-yl)-2-propyl-1h-imidazole-5-carboxylate

132. (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 1-[[2'-(1h-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl]methyl]-4-(2-hydroxypr

133. (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(2-hydroxy-2-propanyl)-2-propyl-1-[[2'-(1h-tetrazol-5-yl)-4-biphenylyl]methyl]-1h-imidazole-5-carboxylate

134. (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-{[2'-(1h-tetrazol-5-yl)biphenyl-4-yl]methyl}-1h-imidazole-5-carboxylate

135. (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl1-((2'-(2h-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-4-(2-hydroxypropan-2-yl)-2-propyl-1h-imidazole-5-carboxylate

136. (5-methyl-2-oxo-1,3-dioxolen-4-yl)methyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2'-(1h-tetrazol-5-yl)biphenyl-4-yl]methyl]imidazole-5-carboxylate

137. (5-methyl-2-oxo-1,3-dioxolen-4-yl)methyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-{4-[2-(tetrazol-5-yl)phenyl]phenyl}methylimidazole-5-carboxylate

138. (5-methyl-2-oxo-1,3-dioxolen-4yl)methyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-{4-[2-(tetrazol-5-yl)phenyl]phenyl}methylimidazole-5-carboxylate

139. (5-methyl-2-oxo-2h-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-{[2'-(1h-1,2,3,4-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl]methyl}-1h-imidazole-5-carboxylate

140. 1h-imidazole-5-carboxylic Acid, 4-(1-hydroxy-1-methylethyl)-2-propyl-1-((2'-(1h-tetrazol-5-yl)(1,1'-biphenyl)-4-yl)methyl)-, (5-methyl-2-oxo-1,3- Dioxol-4-yl)methyl Ester

141. 1h-imidazole-5-carboxylic Acid, 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2'-(2h-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-, (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl Ester

142. 5-(1-hydroxy-1-methylethyl)-2-propyl-3-[2'-(1h-tetrazol-5-yl)-biphenyl-4-ylmethyl]-3h-imidazole-4-carboxylic Acid 5-methyl-2-oxo-[1,3]dioxol-4-ylmethyl Ester

143. 5-(2-hydroxypropan-2-yl)-2-propyl-3-[[4-[2-(2h-tetrazol-5-yl)phenyl]phenyl]methyl]-4-imidazolecarboxylic Acid (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl Ester

144. Olmesartan Medoxomil

145. 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2'-(2h-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1h-imidazole-5-carboxylic Acid-(5-methyl-2-oxo-1,3-dioxol-4-yl)methyl Ester

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 558.6 g/mol
Molecular Formula C29H30N6O6
XLogP33.8
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count10
Rotatable Bond Count11
Exact Mass558.22268270 g/mol
Monoisotopic Mass558.22268270 g/mol
Topological Polar Surface Area154 Ų
Heavy Atom Count41
Formal Charge0
Complexity969
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
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 NameBenicar
Drug LabelBENICAR (olmesartan medoxomil), a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist.Olmesartan medoxomil is described chemically as 2,3-d...
Active IngredientOlmesartan medoxomil
Dosage FormTablet
RouteOral
Strength5mg; 40mg; 20mg
Market StatusPrescription
CompanyDaiichi Sankyo

2 of 6  
Drug NameBenicar hct
PubMed HealthOlmesartan (By mouth)
Drug ClassesCardiovascular Agent, Renal Protective Agent
Active Ingredientolmesartan medoxomil; Hydrochlorothiazide
Dosage FormTablet
RouteOral
Strength25mg; 12.5mg; 40mg; 20mg
Market StatusPrescription
CompanyDaiichi Sankyo

3 of 6  
Drug NameOlmesartan medoxomil
PubMed HealthOlmesartan/Hydrochlorothiazide (By mouth)
Drug ClassesAngiotensin II Receptor Antagonist/Thiazide Combination
Drug LabelBENICAR (olmesartan medoxomil), a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist.Olmesartan medoxomil is described chemically as 2,3-d...
Active IngredientOlmesartan medoxomil
Dosage FormTablet
Routeoral
Strength5mg; 40mg; 20mg
Market StatusTentative Approval
CompanyMylan Pharma; Sandoz

4 of 6  
Drug NameBenicar
Drug LabelBENICAR (olmesartan medoxomil), a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist.Olmesartan medoxomil is described chemically as 2,3-d...
Active IngredientOlmesartan medoxomil
Dosage FormTablet
RouteOral
Strength5mg; 40mg; 20mg
Market StatusPrescription
CompanyDaiichi Sankyo

5 of 6  
Drug NameBenicar hct
PubMed HealthOlmesartan (By mouth)
Drug ClassesCardiovascular Agent, Renal Protective Agent
Active Ingredientolmesartan medoxomil; Hydrochlorothiazide
Dosage FormTablet
RouteOral
Strength25mg; 12.5mg; 40mg; 20mg
Market StatusPrescription
CompanyDaiichi Sankyo

6 of 6  
Drug NameOlmesartan medoxomil
PubMed HealthOlmesartan/Hydrochlorothiazide (By mouth)
Drug ClassesAngiotensin II Receptor Antagonist/Thiazide Combination
Drug LabelBENICAR (olmesartan medoxomil), a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist.Olmesartan medoxomil is described chemically as 2,3-d...
Active IngredientOlmesartan medoxomil
Dosage FormTablet
Routeoral
Strength5mg; 40mg; 20mg
Market StatusTentative Approval
CompanyMylan Pharma; Sandoz

5 Pharmacology and Biochemistry
5.1 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.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Angiotensin 2 Receptor Blocker [EPC]; Angiotensin 2 Receptor Antagonists [MoA]
5.3 ATC Code

C09CA08

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355


C - Cardiovascular system

C09 - Agents acting on the renin-angiotensin system

C09C - Angiotensin ii receptor blockers (arbs), plain

C09CA - Angiotensin ii receptor blockers (arbs), plain

C09CA08 - Olmesartan medoxomil


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Olmesartan medoxomil

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Olmesartan medoxomil

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Olmesartan medoxomil

Registrant Name : Ace Biopharm Co., Ltd.

Registration Date : 2023-02-27

Registration Number : No. 6321-2-ND(5)

Manufacturer Name : Macleods Pharmaceuticals Lim...

Manufacturer Address : Plot No. 2209, GIDC Industrial Estate., At & Post: Sarigam, Tal-Umbergaon, City: Sari...

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Olmesartan medoxomil

Registrant Name : JSP Co., Ltd.

Registration Date : 2023-10-25

Registration Number : 3595-1-ND(9)

Manufacturer Name : Venkata Narayana Active Ingr...

Manufacturer Address : S.No.69, Chandrapadiya Village, Vinjamur Mandal Nellore District- 524228 Andhra Prade...

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Olmesartan medoxomil

Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

Registration Date : 2022-03-18

Registration Number : No. 4766-2-ND(5)

Manufacturer Name : Zhejiang Huahai Pharmaceutic...

Manufacturer Address : Chuannan, Duqiao, Linhai, Zhejiang, China

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Olmesartan medoxomil

Registrant Name : Otran Pharm Korea Co., Ltd.

Registration Date : 2021-07-11

Registration Number : No. 4766-2-ND(4)

Manufacturer Name : Zhejiang Huahai Pharmaceutic...

Manufacturer Address : Chuannan, Duqiao, Linhai, Zhejiang, China

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Olmesartan medoxomil

Registrant Name : SG Biochem Co., Ltd.

Registration Date : 2021-06-24

Registration Number : No. 4766-2-ND(3)

Manufacturer Name : Zhejiang Huahai Pharmaceutic...

Manufacturer Address : Chuannan, Duqiao, Linhai, Zhejiang, China

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04-Jan-2021
28-Nov-2024
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 20MG

USFDA APPLICATION NUMBER - 21286

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DOSAGE - TABLET;ORAL - 40MG

USFDA APPLICATION NUMBER - 21286

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DOSAGE - TABLET;ORAL - 5MG

USFDA APPLICATION NUMBER - 21286

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DOSAGE - TABLET;ORAL - 12.5MG;20MG

USFDA APPLICATION NUMBER - 21532

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DOSAGE - TABLET;ORAL - 12.5MG;40MG

USFDA APPLICATION NUMBER - 21532

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DOSAGE - TABLET;ORAL - 25MG;40MG

USFDA APPLICATION NUMBER - 21532

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

USFDA APPLICATION NUMBER - 22100

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

USFDA APPLICATION NUMBER - 22100

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

USFDA APPLICATION NUMBER - 22100

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

USFDA APPLICATION NUMBER - 22100

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ABOUT THIS PAGE

Olmesartan Manufacturers

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

Olmesartan Suppliers

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

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

Olmesartan USDMF

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

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

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

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

Olmesartan KDMF

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

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

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

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

Olmesartan CEP

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

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

Olmesartan WC

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

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

Olmesartan 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 Olmesartan as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Olmesartan GMP

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

Olmesartan CoA

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

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

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