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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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    03-Jan-2022
    30-May-2025
    KGS
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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

    Looking for 144689-63-4 / Olmesartan Medoxomil API manufacturers, exporters & distributors?

    Olmesartan Medoxomil manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Olmesartan Medoxomil 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 Olmesartan Medoxomil manufacturer or Olmesartan Medoxomil supplier for your needs.

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

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

    API | Excipient name

    Olmesartan Medoxomil

    Synonyms

    144689-63-4, Benicar, Olmetec, Cs-866, Cs 866, Nsc-758924

    Cas Number

    144689-63-4

    Unique Ingredient Identifier (UNII)

    6M97XTV3HD

    About Olmesartan Medoxomil

    An ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKER that is used to manage HYPERTENSION.

    Olmesartan Medoxomil Manufacturers

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

    Olmesartan Medoxomil Suppliers

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

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

    Olmesartan Medoxomil USDMF

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

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

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

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

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

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

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

    Olmesartan Medoxomil CEP

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

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

    Olmesartan Medoxomil WC

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

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

    Olmesartan Medoxomil 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 Medoxomil as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Olmesartan Medoxomil GMP

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

    Olmesartan Medoxomil CoA

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

    Olmesartan Medoxomil CoA mostly includes findings from lab analyses of a specific batch. For each Olmesartan Medoxomil 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 Medoxomil may be tested according to a variety of international standards, such as European Pharmacopoeia (Olmesartan Medoxomil EP), Olmesartan Medoxomil JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Olmesartan Medoxomil 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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