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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

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    Initial Date of Registration : 2014-01-08

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Handok Co., Ltd.

    Registration Date : 2010-11-30

    Registration Number : 20101130-129-H-39-07

    Manufacturer Name : Sanofi Winthrop Industrie

    Manufacturer Address : 45 Chemin De Météline, Sisteron, 04200, France

     VMF ASMF arrow-down
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    Available Reg Filing : ASMF
    AUDIT
    EUROAPI Compnay Banner

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    02

    Sanofi

    France

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

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    BIO International Convention
    Exhibiting
    • fda
    • EDQM
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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 12439

    Submission : 1997-03-06

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    Sanofi Company Banner

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    03

    LGM Pharma

    U.S.A

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

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    CPhI North America
    Booth #1147
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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    Digital Content Digital Content
    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    LGM Pharma CB

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    04

    Metrochem API Private Limited

    India

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

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    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 34334

    Submission : 2020-02-05

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2020-093 - Rev 01

    Issue Date : 2024-06-20

    Type : Chemical

    Substance Number : 2531

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 304MF10071

    Registrant's Address : Flat No. 302, Bhanu Enclave, Sunder Nagar, Erragadda, Hyderabad - 500038, Telangana, India

    Initial Date of Registration : 2022-05-12

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2024-04-23

    Valid Till : 2027-01-21

    Written Confirmation Number : WC-0493

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 42765-004

    Start Marketing Date : 2020-01-17

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

     KDMF VMF Others AUDIT
    Metrochem

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    05

    Dr. Reddy's Laboratories

    India

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

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    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF CEP/COS JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Sangjin Corporation

    Registration Date : 2011-02-25

    Registration Number : 20110225-129-H-88-15

    Manufacturer Name : Dr. Reddy\'s Laboratories Limited

    Manufacturer Address : CTO - Unit-I, Plot Nos. 137,138,145 & 146, SV Co-Op, Industrial Estate, Bollaram Village, Jinnaram Mandal, Sangareddy District, Telangana - 502 325, INDIA

     VMF Others AUDIT
    Dr Reddy Company Banner

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    06

    IOL Chemicals and Pharmaceuticals

    India

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

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    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothIOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.

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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 36534

    Submission : 2022-06-16

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2019-006 - Rev 01

    Issue Date : 2021-06-01

    Type : Chemical

    Substance Number : 2531

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-02-27

    Valid Till : 2027-03-17

    Written Confirmation Number : WC-0004

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 49716-329

    Start Marketing Date : 2023-10-15

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

     KDMF arrow-down
    ✖

    Registrant Name : Aging Life Science Co., Ltd.

    Registration Date : 2025-02-28

    Registration Number : 20250228-129-H-431-62

    Manufacturer Name : IOL Chemicals and Pharmaceuticals Limited

    Manufacturer Address : Village: Fatebgarh Channa, Mansa Road (Trident Complex) Barnala-148101(Punjab), India

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    ✖
    Available Reg Filing : RU
    AUDIT
    IOL Chemicals

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    07

    Jai Radhe Sales

    India

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

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    China Battery Fair
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

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    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    Jai Radhe Sales

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    Virtual Booth

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    08

    HRV Global Life Sciences

    India

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

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    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF AU, MX, ... arrow-down
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    AUDIT
    HRV Global Life Sciences

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    09

    Octavius Pharma Pvt. Ltd

    India

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

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    CPhI China
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothOctavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

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    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    Octavius Pharma

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    10

    Tenatra Chemie

    India

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

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    CPhI China
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothTenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.

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    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    Tenatra

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    USDMF

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    01

    Sanofi Winthrop Industrie

    France
    arrow
    BIO International Convention
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Contact Supplier Contact Supplier
    Flag France
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 14809

    Submission : 2000-03-31

    Status : Active

    Type : II

    Sanofi Company Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    02

    Chinoin Pharmaceutcial And Chemical ...

    France
    arrow
    BIO International Convention
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Flag France
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 14849

    Submission : 2000-05-04

    Status : Inactive

    Type : II

    Sanofi Company Banner

    Portfolio PDF

    Product Web Link

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    Digital Content

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    Corporate PDF

    03

    Sanofi Synthelabo Inc

    France
    arrow
    BIO International Convention
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Flag France
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 12460

    Submission : 1997-04-08

    Status : Inactive

    Type : II

    Sanofi Company Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    04

    Sanofi Aventis Chimie

    France
    arrow
    BIO International Convention
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Contact Supplier Contact Supplier
    Flag France
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 12439

    Submission : 1997-03-06

    Status : Inactive

    Type : II

    Sanofi Company Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    05

    Metrochem Api Private Ltd

    India
    arrow
    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 34334

    Submission : 2020-02-05

    Status : Active

    Type : II

    Metrochem

    Portfolio PDF

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    Virtual Booth

    Digital Content

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    Corporate PDF

    06

    Dr Reddys Laboratories Ltd

    India
    arrow
    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    GDUFA

    DMF Review : Complete

    Rev. Date : 2022-02-15

    Pay. Date : 2022-01-11

    DMF Number : 35506

    Submission : 2020-12-30

    Status : Active

    Type : II

    Dr Reddy Company Banner

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    Digital Content

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    07

    Dr Reddys Laboratories Ltd

    India
    arrow
    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-01-30

    Pay. Date : 2013-01-04

    DMF Number : 16090

    Submission : 2002-08-07

    Status : Active

    Type : II

    Dr Reddy Company Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    08

    Iol Chemicals And Pharmaceuticals Lt...

    India
    arrow
    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothIOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.

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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 36534

    Submission : 2022-06-16

    Status : Active

    Type : II

    IOL Chemicals

    Portfolio PDF

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    Digital Content

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    09

    Tapi Nl Bv

    Israel
    arrow
    TIDES USA
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    GDUFA

    DMF Review : Complete

    Rev. Date : 2012-11-29

    Pay. Date : 2012-11-13

    DMF Number : 17009

    Submission : 2003-12-05

    Status : Active

    Type : II

    TAPI Company Banner

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    10

    China Battery Fair
    Not Confirmed

    10

    Basf Orgamol Pharma Solutions Sa

    Switzerland
    arrow
    China Battery Fair
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15458

    Submission : 2001-05-03

    Status : Inactive

    Type : II

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    KDMF

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    01

    EUROAPI

    France
    arrow
    TIDES USA
    Booth #414, Level 1
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Clopidogrel sulfate

    Registrant Name : Handok Co., Ltd.

    Registration Date : 2010-11-30

    Registration Number : 20101130-129-H-39-07

    Manufacturer Name : Sanofi Winthrop Industrie

    Manufacturer Address : 45 Chemin De Météline, Sisteron, 04200, France

    EUROAPI Compnay Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    02

    Dr. Reddy's Laboratories

    India
    arrow
    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Virtual Booth Virtual Booth
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    Clopidogrel bisulfate

    Registrant Name : Sangjin Corporation

    Registration Date : 2011-02-25

    Registration Number : 20110225-129-H-88-15

    Manufacturer Name : Dr. Reddy's Laboratories Lim...

    Manufacturer Address : CTO - Unit-I, Plot Nos. 137,138,145 & 146, SV Co-Op, Industrial Estate, Bollaram Vill...

    Dr Reddy Company Banner

    Portfolio PDF

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    Virtual Booth

    Digital Content

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    03

    Dr. Reddy's Laboratories

    India
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    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Virtual Booth Virtual Booth
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    Clopidogrel sulfate

    Registrant Name : Pharmasolution Co., Ltd.

    Registration Date : 2018-03-09

    Registration Number : 20110225-129-H-88-15(13)

    Manufacturer Name : Dr.Reddy's Laboratories Limi...

    Manufacturer Address : CTO - Unit-I, Plot Nos. 137,138,145 & 146, SV Co-Op, Industrial Estate, Bollaram Vill...

    Dr Reddy Company Banner

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    04

    Dr. Reddy's Laboratories

    India
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    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Clopidogrel bisulfate

    Registrant Name : EQ Bio Co., Ltd.

    Registration Date : 2024-11-05

    Registration Number : 20110225-129-H-88-15(16)

    Manufacturer Name : Dr. Reddy's Laboratories Lim...

    Manufacturer Address : CTO-Unit I, Plot No. 137, 138, 145 & 146, Sri Venkateswara Co-operative industrial es...

    Dr Reddy Company Banner

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    05

    Dr. Reddy's Laboratories

    India
    arrow
    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Clopidogrel sulfate

    Registrant Name : Hwail Pharmaceutical Co., Ltd.

    Registration Date : 2011-11-11

    Registration Number : 20110225-129-H-88-15(6)

    Manufacturer Name : Dr. Reddy's Laboratories Ltd...

    Manufacturer Address : CTO-Unit-I, Plot Nos. 137,138,145 & 146, SV Co-Op, Industrial Estate, Bollaram Villag...

    Dr Reddy Company Banner

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    06

    Dr. Reddy's Laboratories

    India
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    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Virtual Booth Virtual Booth
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    Clopidogrel sulfate

    Registrant Name : Daewoong Bio Co., Ltd.

    Registration Date : 2012-05-18

    Registration Number : 20110225-129-H-88-15(9)

    Manufacturer Name : Dr. Reddy's Laboratories Lim...

    Manufacturer Address : 137/138,146, Sri Venkateswara Co-operative Industrial estate, Bollaram,_x000D_ Jinnar...

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    07

    Dr. Reddy's Laboratories

    India
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    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Virtual Booth Virtual Booth
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    Clopidogrel bisulfate

    Registrant Name : (주)애거슨바이오

    Registration Date : 2025-02-05

    Registration Number : 20110225-129-H-88-15(17)

    Manufacturer Name : Dr. Reddy's Laboratories Lim...

    Manufacturer Address : CTO - Unit-I, Plot Nos. 137,138,145 & 146, SV Co-Op, Industrial Estate, Bollaram Vill...

    Dr Reddy Company Banner

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    08

    Dr. Reddy's Laboratories

    India
    arrow
    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Virtual Booth Virtual Booth
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    Clopidogrel sulfate

    Registrant Name : Dongwha Pharmaceutical Co., Ltd.

    Registration Date : 2011-06-15

    Registration Number : 20110225-129-H-88-15(2)

    Manufacturer Name : Dr. Reddy's Laboratories Lim...

    Manufacturer Address : CTO - Unit-I, Plot Nos. 137,138,145 & 146, SV Co-Op, Industrial Estate, Bollaram Vill...

    Dr Reddy Company Banner

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    09

    Dr. Reddy's Laboratories

    India
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    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Clopidogrel sulfate

    Registrant Name : IMCD Korea Co., Ltd.

    Registration Date : 2017-12-08

    Registration Number : 20110225-129-H-88-15(12)

    Manufacturer Name : Dr. Reddy's Laboratories Lim...

    Manufacturer Address : CTO-Unit-I, Plot Nos. 137,138,145 & 146, SV Co-Op, Industrial Estate, Bollaram Villag...

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    10

    Dr. Reddy's Laboratories

    India
    arrow
    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Clopidogrel sulfate

    Registrant Name : Korea Pharmaceutical Co., Ltd.

    Registration Date : 2011-05-16

    Registration Number : 20110225-129-H-88-15(1)

    Manufacturer Name : Dr. Reddy's Laboratories Lim...

    Manufacturer Address : CTO - Unit-I, Plot Nos. 137,138,145 & 146, SV Co-Op, Industrial Estate, Bollaram Vill...

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    06-Mar-2021
    24-Mar-2025
    KGS
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    INTERMEDIATE SUPPLIERS

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    01

    EUROAPI

    France
    TIDES USA
    Booth #414, Level 1
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    Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

    2-(2-thienyl)ethylamine

    CAS Number : 30433-91-1

    End Use API : Clopidogrel

    About The Company : EUROAPI is focused on reinventing active ingredient solutions to meet the needs of customers and patients worldwide sustainably. We are a leading player in APIs...

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    02

    IOL Chemicals and Pharmaceuticals

    India
    CPhI North America
    Attending
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    Virtual BoothIOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.

    (S)-Methyl 2-(2-chlorophenyl)-2-((2-(thiophen-2-yl...

    CAS Number : 141109-19-5

    End Use API : Clopidogrel

    About The Company : With a history spanning over three decades, IOL Chemicals and Pharmaceuticals Limited is an innovation-driven company that specializes in bulk drugs, intermedia...

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    03

    Amara Labs

    India
    China Battery Fair
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    Amara Labs

    India
    China Battery Fair
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    S-(+)-METHYL-ALPHA-(2-THIENYLETHYL AMINO)(2CHLOROP...

    CAS Number : 141109-19-5

    End Use API : Clopidogrel

    About The Company : Amara Labs Pvt Ltd is a WHO-GMP certified manufacturing company wholly owned by a team of technocrats with working experience of more than 20 years in Multi-Nat...

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    04

    Blue Jet Healthcare

    India
    China Battery Fair
    Not Confirmed
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    Blue Jet Healthcare

    India
    China Battery Fair
    Not Confirmed
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    (S)-methyl-2-(2- chlorophenyl)-2-(2- thiophen-2-yl...

    CAS Number : CAS-141109-19-5

    End Use API : Clopidogrel

    About The Company : Blue Jet Healthcare is a global, science-driven pharmaceutical company specializing in collaboration, development, and manufacturing of advanced pharmaceutical ...

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    05

    Curequest Lifescience

    India
    China Battery Fair
    Not Confirmed
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    Curequest Lifescience

    India
    China Battery Fair
    Not Confirmed
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    D-(+)-Methyl-alpha-(2-thienylethamino)(2-chlorophe...

    CAS Number : 141109-19-5

    End Use API : Clopidogrel

    About The Company : Curequest lifescience LLP is in the business of manufacturing and exports of Active Pharmaceutical Ingredients (APIs) and API Intermediates. We are a team of yo...

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    Delta Finochem P Ltd

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    Methyl alpha-bromo-2-chloro-phenylacetate

    CAS Number : 85259-19-4

    End Use API : Clopidogrel

    About The Company : Delta Finochem Pvt Ltd. is a privately owned and professionally managed company, accredited by WHO-GMP & ISO 9001:2015 (Year of establishment 1994) Delta Finoch...

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    Exemed Pharmaceuticals

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    4,5,6,7-Tetrahydrothieno[3,2-c]pyridine Hydrochlor...

    CAS Number : 28783-41-7

    End Use API : Clopidogrel

    About The Company : Exemed, with due global accreditations from US FDA, KFDA and other regulatory bodies, is one of the leading and cost-competitive manufacturers of Metformin. Bes...

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    Exemed Pharmaceuticals

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    S-(+)-Methyl-(2-chlorophenyl)[(2-(2- thienyl)amino...

    CAS Number : 141109-19-5

    End Use API : Clopidogrel

    About The Company : Exemed, with due global accreditations from US FDA, KFDA and other regulatory bodies, is one of the leading and cost-competitive manufacturers of Metformin. Bes...

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    Indian Tex Dyes Industries

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    Methyl-(4,5,6,7-tetrahydro-5-thieno [3,2-c] pyridy...

    CAS Number : 144750-52-7

    End Use API : Clopidogrel

    About The Company : TEXLAB INDUSTRIES was established in 1971, manufacturing & trading related business. TEXLAB INDUSTRIES - company launched by Late Shree AMBALAL MISTRY for local...

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    S(+)-2-(2-Chloropheny)-6,7-dihydrothieno (3,2- C)p...

    CAS Number : 120202-68-8

    End Use API : Clopidogrel

    About The Company : TEXLAB INDUSTRIES was established in 1971, manufacturing & trading related business. TEXLAB INDUSTRIES - company launched by Late Shree AMBALAL MISTRY for local...

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    DOSAGE - TABLET;ORAL - EQ 300MG BASE

    USFDA APPLICATION NUMBER - 20839

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    ABOUT THIS PAGE

    Looking for 135046-48-9 / Clopidogrel API manufacturers, exporters & distributors?

    Clopidogrel manufacturers, exporters & distributors 1

    19

    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.

    Clopidogrel Bisulfate Manufacturers

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

    Clopidogrel Bisulfate Suppliers

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

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

    Clopidogrel Bisulfate USDMF

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

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

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

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

    Clopidogrel Bisulfate KDMF

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

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

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

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

    Clopidogrel Bisulfate CEP

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

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

    Clopidogrel Bisulfate WC

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

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

    Clopidogrel Bisulfate 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 Clopidogrel Bisulfate as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Clopidogrel Bisulfate GMP

    Clopidogrel Bisulfate 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 Clopidogrel Bisulfate 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 Clopidogrel Bisulfate GMP manufacturer or Clopidogrel Bisulfate GMP API supplier for your needs.

    Clopidogrel Bisulfate CoA

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

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

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