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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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AREA,PHASE-II"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718303400,"product":"CLOPIDOGREL\/CLOPIDOGREL BISULPHATE (REJECTED MATERIAL VIDE SB NO:2871774\/16.07.22 INV NO:U08\/22-23\/157\/31.05.22)","address":"Floor No.22, Plot No.1, Survey No.83\/1, Galaxy Tower","city":"Hyderabad","supplier":"ACHE LABORATORIOS FARMACEUTICOS SA.","supplierCountry":"INDIA","foreign_port":"RECIFE , PE","customer":"APITORIA PHARMA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"217.76","actualQuantity":"217.76","unit":"KGS","unitRateFc":"475","totalValueFC":"126518.4","currency":"USD","unitRateINR":"48501.5","date":"14-Jun-2024","totalValueINR":"10561681.88","totalValueInUsd":"126518.4","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"3989779","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"RECIFE , PE","supplierAddress":"RODOVIA PE 09 5601 CEP 54590-000 ZONA INDUSTRIAL DE SUAPE-CABO DE SANTO AGOSTINHO-PE-BRASIL Brazil","customerAddress":"Floor No.22, Plot No.1, Survey No.83\/1, Galaxy Tower"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733769000,"product":"CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK","city":"KURLA, MUMBAI","supplier":"APOTEX INC","supplierCountry":"MEXICO","foreign_port":"MEXICO CITY","customer":"PIRAMAL PHARMA SOLUTIONS","customerCountry":"INDIA","quantity":"574.22","actualQuantity":"574.22","unit":"KGS","unitRateFc":"268","totalValueFC":"155124.4","currency":"USD","unitRateINR":"22954.2","date":"10-Dec-2024","totalValueINR":"13180760.72","totalValueInUsd":"155124.4","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"7142552","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MEXICO","selfForZScoreResived":"Pharma Grade","supplierPort":"MEXICO CITY","supplierAddress":"AV.INDUSTRIA AUTOMOTRIZ NO.301 5007 1 TOLUCA , EDO.DE MEXICO , CP 50071 ESTADO DE MEXICO Mexico City, , Me Mexico","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733769000,"product":"CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK","city":"KURLA, MUMBAI","supplier":"APOTEX INC","supplierCountry":"MEXICO","foreign_port":"MEXICO CITY","customer":"PIRAMAL PHARMA SOLUTIONS","customerCountry":"INDIA","quantity":"578.16","actualQuantity":"578.16","unit":"KGS","unitRateFc":"268","totalValueFC":"156188.8","currency":"USD","unitRateINR":"22954.2","date":"10-Dec-2024","totalValueINR":"13271200.27","totalValueInUsd":"156188.8","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"7142324","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MEXICO","selfForZScoreResived":"Pharma Grade","supplierPort":"MEXICO CITY","supplierAddress":"AV.INDUSTRIA AUTOMOTRIZ NO.301 5007 1 TOLUCA , EDO.DE MEXICO , CP 50071 ESTADO DE MEXICO Mexico City, , Me Mexico","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1735324200,"product":"DRUG AND DRUG INTERMEDIATES - CLOPIDOGREL HYDROGEN SULFATE EP (EXPORT REJECTED GOODS, N.F.E.I) 324.892 KGX190 = 61729.48DRUG AND DRUG INTERMEDIATES - CLOPIDOGREL HYDROGEN SULFATE E","address":"15, SATYAM APARTMENTS, JAGABHAI","city":"AHMEDABAD","supplier":"RUE BELMEDPREPARATY","supplierCountry":"INDIA","foreign_port":"MINSK","customer":"GREENCROSS EXPORT PRIVATE ","customerCountry":"INDIA","quantity":"324.89","actualQuantity":"324.892","unit":"KGS","unitRateFc":"192.1","totalValueFC":"63144.7","currency":"USD","unitRateINR":"16514.2","date":"28-Dec-2024","totalValueINR":"5365337.36","totalValueInUsd":"63144.7","indian_port":"Ahmedabad Air","hs_no":"29331999","bill_no":"7500255","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"MINSK","supplierAddress":"30 Fabritsius St., 220007 Minsk Belarus SDNF BELARUS","customerAddress":"15, SATYAM APARTMENTS, JAGABHAI"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1735324200,"product":"CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK","city":"KURLA, MUMBAI","supplier":"APOTEX INC","supplierCountry":"MEXICO","foreign_port":"MEXICO CITY","customer":"PIRAMAL PHARMA SOLUTIONS","customerCountry":"INDIA","quantity":"872.10","actualQuantity":"872.1","unit":"KGS","unitRateFc":"268","totalValueFC":"236421.3","currency":"USD","unitRateINR":"23034.6","date":"28-Dec-2024","totalValueINR":"20088474.66","totalValueInUsd":"236421.3","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"7496073","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MEXICO","selfForZScoreResived":"Pharma Grade","supplierPort":"MEXICO CITY","supplierAddress":"AV.INDUSTRIA AUTOMOTRIZ NO.301 5007 1 TOLUCA , EDO.DE MEXICO , CP 50071 ESTADO DE MEXICO Mexico City, , Me Mexico","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK"}]
04-Jan-2021
31-Jan-2025
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FDA Orange Book

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01

  • fda
  • EDQM
  • WHO-GMP

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

Flag France
Digital Content Digital Content

RLD : Yes

TE Code : AB

CLOPIDOGREL BISULFATE

Brand Name : PLAVIX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 75MG BASE

Approval Date : 1997-11-17

Application Number : 20839

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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RLD : Yes

TE Code : AB

CLOPIDOGREL BISULFATE

Brand Name : PLAVIX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 300MG BASE

Approval Date : 2007-09-20

Application Number : 20839

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Sanofi Company Banner

03

DR REDDYS

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

Flag India
Digital Content Digital Content

RLD : No

TE Code : AB

CLOPIDOGREL BISULFATE

Brand Name : CLOPIDOGREL BISULFATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 75MG BASE

Approval Date : 2008-01-14

Application Number : 76273

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

04

ACME LABS

Bangladesh
ASPEN
Not Confirmed
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ACME LABS

Bangladesh
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ASPEN
Not Confirmed

CLOPIDOGREL BISULFATE

Brand Name : CLOPIDOGREL BISULFATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 75MG BASE

Approval Date : 2012-05-17

Application Number : 78004

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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05

CHARTWELL RX

U.S.A
ASPEN
Not Confirmed
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CHARTWELL RX

U.S.A
arrow
ASPEN
Not Confirmed

CLOPIDOGREL BISULFATE

Brand Name : CLOPIDOGREL BISULFATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 75MG BASE

Approval Date : 2012-08-14

Application Number : 202266

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

blank

06

CHARTWELL RX

U.S.A
ASPEN
Not Confirmed
arrow

CHARTWELL RX

U.S.A
arrow
ASPEN
Not Confirmed

CLOPIDOGREL BISULFATE

Brand Name : CLOPIDOGREL BISULFATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 300MG BASE

Approval Date : 2012-11-20

Application Number : 202266

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

blank

07

ASPEN
Not Confirmed
arrow
arrow
ASPEN
Not Confirmed

CLOPIDOGREL BISULFATE

Brand Name : CLOPIDOGREL BISULFATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 75MG BASE

Approval Date : 2023-08-04

Application Number : 205345

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

blank

08

ASPEN
Not Confirmed
arrow
arrow
ASPEN
Not Confirmed

CLOPIDOGREL BISULFATE

Brand Name : CLOPIDOGREL BISULFATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 300MG BASE

Approval Date : 2023-08-04

Application Number : 205345

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

blank

09

RISING

U.S.A
ASPEN
Not Confirmed
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RISING

U.S.A
arrow
ASPEN
Not Confirmed

CLOPIDOGREL BISULFATE

Brand Name : CLOPIDOGREL BISULFATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 300MG BASE

Approval Date : 2012-05-17

Application Number : 77665

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

blank

10

ASPEN
Not Confirmed
arrow
arrow
ASPEN
Not Confirmed

CLOPIDOGREL BISULFATE

Brand Name : CLOPIDOGREL BISULFATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 75MG BASE

Approval Date : 2013-06-10

Application Number : 78133

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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Europe

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Regulatory Info :

Registration Country : Sweden

klopidogrelvätesulfat

Brand Name : Iscover

Dosage Form : FILM COATED PILL

Dosage Strength : 300 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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Regulatory Info :

Registration Country : Sweden

klopidogrelvätesulfat

Brand Name : Iscover

Dosage Form : FILM COATED PILL

Dosage Strength : 75 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Italy

Clopidogrel; Aspirin

Brand Name : Duoplavin

Dosage Form : Clopidogrel+Acetylsalicylic Acid+10075 Mg 28 Combined Oral Use

Dosage Strength : 28 cpr riv 75 mg + 100 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Regulatory Info :

Registration Country : Italy

Clopidogrel

Brand Name : Plavix

Dosage Form : Clopidogrel 300Mg 30 Joined' Oral Use

Dosage Strength : 30 cpr riv 300 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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05

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Flag France
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Regulatory Info :

Registration Country : Norway

Clopidogrel

Brand Name : Plavix

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 300 mg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Sanofi Company Banner

06

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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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Digital Content Digital Content

Regulatory Info :

Registration Country : Norway

Clopidogrel

Brand Name : Plavix

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 75 mg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Sanofi Company Banner

07

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

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Norway

Clopidogrel

Brand Name : Plavix

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 75 mg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Sanofi Company Banner

08

  • fda
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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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Digital Content Digital Content

Regulatory Info :

Registration Country : Norway

Clopidogrel

Brand Name : Plavix

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 75 mg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Sanofi Company Banner

09

Helvepharm AG

France
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Regulatory Info :

Registration Country : Switzerland

Clopidogrelum

Brand Name : Clopidogrel Zentiva

Dosage Form : Filmtabl

Dosage Strength : 75mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

10

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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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Regulatory Info :

Registration Country : Switzerland

Clopidogrelum

Brand Name : Plavix

Dosage Form : Tabl

Dosage Strength : 75mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner
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DOSAGE - TABLET;ORAL - EQ 300MG BASE

USFDA APPLICATION NUMBER - 20839

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DOSAGE - TABLET;ORAL - EQ 75MG 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 Manufacturers

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

Clopidogrel Suppliers

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

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

Clopidogrel USDMF

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

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

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

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

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

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

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

Clopidogrel CEP

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

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

Clopidogrel WC

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

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

Clopidogrel 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 as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Clopidogrel GMP

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

Clopidogrel CoA

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

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