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    Chemistry

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    Also known as: 120202-66-6, Clopidogrel sulfate, Clopidogrel hydrogen sulfate, Iscover, Plavix, Clopidogrel bisulphate
    Molecular Formula
    C16H18ClNO6S2
    Molecular Weight
    419.9  g/mol
    InChI Key
    FDEODCTUSIWGLK-RSAXXLAASA-N
    FDA UNII
    08I79HTP27
    Clopidogrel
    A ticlopidine analog and platelet purinergic P2Y receptor antagonist that inhibits adenosine diphosphate-mediated PLATELET AGGREGATION. It is used to prevent THROMBOEMBOLISM in patients with ARTERIAL OCCLUSIVE DISEASES; MYOCARDIAL INFARCTION; STROKE; or ATRIAL FIBRILLATION.
    1 2D Structure

    Clopidogrel

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    methyl (2S)-2-(2-chlorophenyl)-2-(6,7-dihydro-4H-thieno[3,2-c]pyridin-5-yl)acetate;sulfuric acid
    2.1.2 InChI
    InChI=1S/C16H16ClNO2S.H2O4S/c1-20-16(19)15(12-4-2-3-5-13(12)17)18-8-6-14-11(10-18)7-9-21-14;1-5(2,3)4/h2-5,7,9,15H,6,8,10H2,1H3;(H2,1,2,3,4)/t15-;/m0./s1
    2.1.3 InChI Key
    FDEODCTUSIWGLK-RSAXXLAASA-N
    2.1.4 Canonical SMILES
    COC(=O)C(C1=CC=CC=C1Cl)N2CCC3=C(C2)C=CS3.OS(=O)(=O)O
    2.1.5 Isomeric SMILES
    COC(=O)[C@H](C1=CC=CC=C1Cl)N2CCC3=C(C2)C=CS3.OS(=O)(=O)O
    2.2 Other Identifiers
    2.2.1 UNII
    08I79HTP27
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Clopidogrel

    2. Clopidogrel Besilate

    3. Clopidogrel Besylate

    4. Clopidogrel Hydrochloride

    5. Clopidogrel Mepha

    6. Clopidogrel Napadisilate

    7. Clopidogrel Sandoz

    8. Clopidogrel, (+)(s)-isomer

    9. Clopidogrel-mepha

    10. Iscover

    11. Pcr 4099

    12. Pcr-4099

    13. Plavix

    14. Sc 25989c

    15. Sc 25990c

    16. Sr 25989

    2.3.2 Depositor-Supplied Synonyms

    1. 120202-66-6

    2. Clopidogrel Sulfate

    3. Clopidogrel Hydrogen Sulfate

    4. Iscover

    5. Plavix

    6. Clopidogrel Bisulphate

    7. Clopidogrel Hemisulfate

    8. (s)-methyl 2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4h)-yl)acetate Sulfate

    9. Clopidogrel Hydrogen Sulphate

    10. Clopidogrel Bms

    11. Clopidogrel Sulphate

    12. Sr 25990c

    13. Clopidogrel (hydrogen Sulfate)

    14. Isocover

    15. Pidogrel

    16. Clopidogrel-bgr

    17. Clopidogrel-bms

    18. Clopidogrel Teva

    19. Clopidogrel Zentiva

    20. Clopidogrel (plavix)

    21. Clopidogrel Ratiopharm

    22. Sr-25990c

    23. S-(+)-clopidogrel Hydrogen Sulfate

    24. Clopidogrel (as Bisulfate)

    25. (s)-(+)-clopidogrel Sulfate

    26. 08i79htp27

    27. 120202-66-6 (sulfate)

    28. Pm-103

    29. Methyl (s)-2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4h)-yl)acetate Sulfate

    30. 144077-07-6

    31. Myogrel

    32. Clopidogrel Hydrogensulfate

    33. Plavix (tn)

    34. Dsstox_cid_26024

    35. Dsstox_rid_81297

    36. Dsstox_gsid_46024

    37. Plavitor

    38. Osvix

    39. Chebi:3759

    40. Chembl1083385

    41. Methyl (2s)-2-(2-chlorophenyl)-2-(6,7-dihydro-4h-thieno[3,2-c]pyridin-5-yl)acetate Sulfate

    42. Methyl (2s)-2-(2-chlorophenyl)-2-(6,7-dihydro-4h-thieno[3,2-c]pyridin-5-yl)acetate;sulfuric Acid

    43. Sulfuric Acid Methyl (2s)-2-(2-chlorophenyl)-2-{4h,5h,6h,7h-thieno[3,2-c]pyridin-5-yl}acetate

    44. Clopidogrel Bisulfate [usan]

    45. Cas-135046-48-9

    46. Unii-08i79htp27

    47. R-(-)-clopidogrel Hydrogen Sulfate

    48. Clopidogrel Bisulfate [usan:usp]

    49. Isocover (tn)

    50. Clopidogrel Bisolfato

    51. (s)-(+)-clopidogrel Hydrogen Sulfate

    52. Bisulfato De Clopidogrel

    53. Bissulfato De Clopidogrel

    54. Ncgc00159321-02

    55. (+)-clopidogrel Bisulfate

    56. (+) Clopidogrel Bisulfate

    57. Methyl Alphas-(2-chlorophenyl)-6,7-dihydrothieno(3,2-c)pyridine-5(4h)-acetate Sulfate (1:1)

    58. Clopidogrel Bisulfate (usp)

    59. Clopidogrel Sulfate (jp17)

    60. Schembl33556

    61. Clopidogrel Hydrogen Sulphate

    62. Spectrum1503710

    63. Mdco-157

    64. (+)-clopidogrel Hydrogen Sulfate

    65. Clopidogrel Sulfate [jan]

    66. Dtxsid601016080

    67. Hms1922g16

    68. Hms2093i13

    69. Hms3884g15

    70. Pharmakon1600-01503710

    71. Amy40591

    72. Clopidogrel Sulfate Tablets (jp17)

    73. Tox21_111570

    74. Ccg-39568

    75. Clopidogrel Bisulfate [vandf]

    76. Mfcd00876395

    77. Nsc758613

    78. S1415

    79. Clopidogrel Bisulfate [mart.]

    80. Akos015900408

    81. Clopidogrel Bisulfate [usp-rs]

    82. Clopidogrel Bisulfate [who-dd]

    83. Tox21_111570_1

    84. Ac-2135

    85. Cs-1882

    86. Dv-7314

    87. Ks-1045

    88. S65c842

    89. Clopidogrel (as Hydrogen Sulfate)

    90. Clopidogrel Hydrogen Sulfate [mi]

    91. Ncgc00163329-03

    92. 111ge004

    93. Bc164326

    94. Hy-17459

    95. Methyl (+)-(s)-alpha-(o-chlorophenyl)-6,7-dihydrothieno(3,2-c)pyridine-5(4h)-acetate, Sulfate (1:1)

    96. Thieno(3,2-c)pyridine-5(4h)-acetic Acid, 6,7-dihydro-alpha-(2-chlorophenyl)-, Methyl Ester, (s)-, Sulfate

    97. Thieno(3,2-c)pyridine-5(4h)-acetic Acid, Alpha-(2-chlorophenyl)-6,7-dihydro-, Methyl Ester, (alphas)-, Sulfate (1:1)

    98. Thieno(3,2-c)pyridine-5(4h)-acetic Acid, Alpha-(2-chlorophenyl)-6,7-dihydro-, Methyl Ester, (s)-, Sulfate (1:1)

    99. Thieno[3,2-c]pyridine-5(4h)-acetic Acid,a-(2-chlorophenyl)-6,7-dihydro-, Methyl Ester, (as)-, Sulfate (1:1)

    100. Clopidogrel Bisulfate [orange Book]

    101. Clopidogrel Bisulfate [usp Monograph]

    102. Sw219457-1

    103. Clopidogrel Hydrogen Sulfate [ema Epar]

    104. D00769

    105. Duocover Component Clopidogrel Bisulfate

    106. Duoplavin Component Clopidogrel Bisulfate

    107. Clopidogrel Hydrogen Sulphate [ema Epar]

    108. Clopidogrel Bisulfate Component Of Duocover

    109. Clopidogrel Bisulfate Component Of Duoplavin

    110. Clopidogrel Hydrogen Sulfate [ep Monograph]

    111. Sr-05000002068

    112. J-006637

    113. Sr-05000002068-1

    114. (+)-clopidogrel1r(-)camphor-10-sulphonic Acid Salt

    115. (s)-(+)-clopidogrel Hydrogensulfate, >=98% (hplc)

    116. Q27888063

    117. Z1550648767

    118. (s)-(+)-clopidogrel Bisulfate;(s)-(+)-clopidogrel Hydrogen Sulfate

    119. Clopidogrel Bisulfate, United States Pharmacopeia (usp) Reference Standard

    120. Clopidogrel Hydrogen Sulfate, European Pharmacopoeia (ep) Reference Standard

    121. Clopidogrel/acetylsalicyclic Acid Teva Component Clopidogrel Bisulfate

    122. (s)-(+)-methyl (2-chlorophenyl)(6,7-dihydro-4h-thieno(3,2-c)pyrid-5-yl)acetate Bisulfate

    123. Clopidogrel Bisulfate Component Of Clopidogrel/acetylsalicyclic Acid Teva

    124. Clopidogrel Bisulfate, Pharmaceutical Secondary Standard; Certified Reference Material

    125. Clopidogrel For System Suitability, European Pharmacopoeia (ep) Reference Standard

    126. Methyl(s)-2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4h)-yl)acetatesulfate

    127. (s)-(+)-methyl 2-(4,5,6,7-tetrahydrothieno[3,2-c]pyridin-5-yl)-2-(2-chlorophenyl)acetate Hydrogen Sulfate

    128. (s)-(2-chloro-phenyl)-(6,7-dihydro-4h-thieno[3,2-c]pyridin-5-yl)-acetic Acid Methyl Ester Sulfuric Acid Salt

    129. (s)-methyl-(2-chloro-phenyl)-(6,7-dihydro-4h-thieno[3,2-c]pyridin-5-yl)-acetate H2so4

    130. Methyl (+)-(s)-.alpha.-(o-chlorophenyl)-6,7-dihydrothieno(3,2-c)pyridine-5(4h)-acetate, Sulfate (1:1)

    131. Methyl (+)-(s)-.alpha.-(o-chlorophenyl)-6,7-dihydrothieno(3,2-c)pyridine-5(4h)-acetate, Sulphate (1:1)

    132. Methyl (2s)-2-(2-chlorophenyl)-2-{4h,5h,6h,7h-thieno[3,2-c]pyridin-5-yl}acetate; Sulfuric Acid

    133. Methyl (s)-(+)-2-(2-chlorophenyl)-2-[6,7-dihydro-4h-thieno[3,2-c]pyridin-5-yl]acetate Sulfate

    134. Thieno(3,2-c)pyridine-5(4h)-acetic Acid, .alpha.-(2-chlorophenyl)-6,7-dihydro-, Methyl Ester, (s)-, Sulfate (1:1)

    135. Thieno(3,2-c)pyridine-5(4h)-acetic Acid, .alpha.-(2-chlorophenyl)-6,7-dihydro-, Methyl Ester, (s)-, Sulphate (1:1)

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 419.9 g/mol
    Molecular Formula C16H18ClNO6S2
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count4
    Exact Mass419.0264073 g/mol
    Monoisotopic Mass419.0264073 g/mol
    Topological Polar Surface Area141 Ų
    Heavy Atom Count26
    Formal Charge0
    Complexity463
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameClopidogrel bisulfate
    Drug LabelClopidogrel bisulfate USP is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)--(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)acetate sulfate (1:1). The molecular formula of clopidogrel bisul...
    Active IngredientClopidogrel bisulfate
    Dosage FormTablet
    RouteOral
    Strengtheq 300mg base; eq 75mg base
    Market StatusPrescription
    CompanyWockhardt; Mylan Pharms; Actavis Elizabeth; Teva Pharms; Macleods Pharms; Mutual Pharm; Gate Pharms; Teva; Apotex; Accord Hlthcare; Sciegen Pharms; Aurobindo Pharma; Torrent Pharms; Zydus Pharms Usa; Dr Reddys Labs; Sun Pharma Global; Roxane

    2 of 4  
    Drug NamePlavix
    PubMed HealthClopidogrel (By mouth)
    Drug ClassesPlatelet Aggregation Inhibitor
    Drug LabelPlavix (clopidogrel bisulfate) is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)--(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The empirical formula of clopidogrel...
    Active IngredientClopidogrel bisulfate
    Dosage FormTablet
    RouteOral
    Strengtheq 75mg base; eq 300mg base
    Market StatusPrescription
    CompanySanofi Aventis Us

    3 of 4  
    Drug NameClopidogrel bisulfate
    Drug LabelClopidogrel bisulfate USP is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)--(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)acetate sulfate (1:1). The molecular formula of clopidogrel bisul...
    Active IngredientClopidogrel bisulfate
    Dosage FormTablet
    RouteOral
    Strengtheq 300mg base; eq 75mg base
    Market StatusPrescription
    CompanyWockhardt; Mylan Pharms; Actavis Elizabeth; Teva Pharms; Macleods Pharms; Mutual Pharm; Gate Pharms; Teva; Apotex; Accord Hlthcare; Sciegen Pharms; Aurobindo Pharma; Torrent Pharms; Zydus Pharms Usa; Dr Reddys Labs; Sun Pharma Global; Roxane

    4 of 4  
    Drug NamePlavix
    PubMed HealthClopidogrel (By mouth)
    Drug ClassesPlatelet Aggregation Inhibitor
    Drug LabelPlavix (clopidogrel bisulfate) is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)--(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The empirical formula of clopidogrel...
    Active IngredientClopidogrel bisulfate
    Dosage FormTablet
    RouteOral
    Strengtheq 75mg base; eq 300mg base
    Market StatusPrescription
    CompanySanofi Aventis Us

    4.2 Drug Indication

    Secondary prevention of atherothrombotic events Clopidogrel is indicated in:

    - Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.

    - Adult patients suffering from acute coronary syndrome:

    - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA).

    - ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.

    Prevention of atherothrombotic and thromboembolic events in atrial fibrillation

    In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.

    Secondary prevention of atherothrombotic events

    Clopidogrel is indicated in:

    - Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.

    - Adult patients suffering from acute coronary syndrome:

    - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA).

    - ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.

    - Prevention of atherothrombotic and thromboembolic events in atrial fibrillation

    In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.

    * Secondary prevention of atherothrombotic events:

    Clopidogrel is indicated in:

    - Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.

    - Adult patients suffering from acute coronary syndrome:

    - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA).

    - ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.

    In patients with moderate to high-risk Transient Ischemic Attack (TIA) or minor Ischemic Stroke (IS)

    Clopidogrel in combination with ASA is indicated in:

    - Adult patients with moderate to high-risk TIA (ABCD2 score 4) or minor IS (NIHSS 3) within 24 hours of either the TIA or IS event.

    * Prevention of atherothrombotic and thromboembolic events in atrial fibrillation:

    In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.

    Prevention of atherothrombotic events Clopidogrel is indicated in:

    Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.

    Prevention Secondary prevention of atherothrombotic events Clopidogrel is indicated in:

    - Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.

    - Adult patients suffering from acute coronary syndrome:

    - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA).

    - ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.

    - Prevention of atherothrombotic and thromboembolic events in atrial fibrillation:

    - In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.

    * Secondary prevention of atherothrombotic events:

    Clopidogrel is indicated in:

    - adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from seven days until less than six months) or established peripheral arterial disease;

    - adult patients suffering from acute coronary syndrome:

    - non-ST-segment-elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA);

    - ST-segment-elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.

    - In patients with moderate to high-risk Transient Ischemic Attack (TIA) or minor Ischemic Stroke (IS)

    Clopidogrel in combination with ASA is indicated in:

    - Adult patients with moderate to high-risk TIA (ABCD2 score 4) or minor IS (NIHSS 3) within 24 hours of either the TIA or IS event.

    * Prevention of atherothrombotic and thromboembolic events in atrial fibrillation:

    In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin-K antagonists and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.

    Clopidogrel is indicated in adults for the prevention of atherothrombotic events in:

    - patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.

    For further information please refer to section 5. 1.

    Clopidogrel is indicated in adults for the prevention of atherothrombotic events in:

    - Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.

    - Patients suffering from acute coronary syndrome:

    Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA).

    ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Platelet Aggregation Inhibitors

    Drugs or agents which antagonize or impair any mechanism leading to blood platelet aggregation, whether during the phases of activation and shape change or following the dense-granule release reaction and stimulation of the prostaglandin-thromboxane system. (See all compounds classified as Platelet Aggregation Inhibitors.)

    Purinergic P2Y Receptor Antagonists

    Compounds that bind to and block the stimulation of PURINERGIC P2Y RECEPTORS. Included under this heading are antagonists for specific P2Y receptor subtypes. (See all compounds classified as Purinergic P2Y Receptor Antagonists.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Decreased Platelet Aggregation [PE]; P2Y12 Platelet Inhibitor [EPC]; P2Y12 Receptor Antagonists [MoA]; Cytochrome P450 2C8 Inhibitors [MoA]
    5.3 ATC Code

    B01AC04

    B01AC04

    B01AC04

    B01AC03

    B01AC04

    B01AC04

    B01AC04

    B01AC04

    API Reference Price

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    02-Jan-2021
    25-Mar-2025
    KGS
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    PharmaCompass offers a list of Clopidogrel 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 Clopidogrel manufacturer or Clopidogrel supplier for your needs.

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

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

    API | Excipient name

    Clopidogrel

    Synonyms

    120202-66-6, Clopidogrel sulfate, Clopidogrel hydrogen sulfate, Iscover, Plavix, Clopidogrel bisulphate

    Cas Number

    135046-48-9

    Unique Ingredient Identifier (UNII)

    08I79HTP27

    About Clopidogrel

    A ticlopidine analog and platelet purinergic P2Y receptor antagonist that inhibits adenosine diphosphate-mediated PLATELET AGGREGATION. It is used to prevent THROMBOEMBOLISM in patients with ARTERIAL OCCLUSIVE DISEASES; MYOCARDIAL INFARCTION; STROKE; or ATRIAL FIBRILLATION.

    Plavix Manufacturers

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

    Plavix Suppliers

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

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

    Plavix USDMF

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

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

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

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

    Plavix KDMF

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

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

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

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

    Plavix CEP

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

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

    Plavix WC

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

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

    Plavix 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 Plavix as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Plavix GMP

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

    Plavix CoA

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

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

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