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

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CLOPIDOGREL SULPHATE FORM-Ⅱ

Registration Number : 303MF10053

Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

Initial Date of Registration : 2021-03-26

Latest Date of Registration : 2021-03-26

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

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CLOPIDOGREL SULFATE FORM-Ⅰ

Registration Number : 304MF10059

Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA

Initial Date of Registration : 2022-03-30

Latest Date of Registration : 2022-03-30

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

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Clopidogrel sulfate

Registration Number : 226MF10008

Registrant's Address : 82 Avenue Raspail 94250 Gentilly (FRANCE)

Initial Date of Registration : 2014-01-08

Latest Date of Registration : 2015-04-09

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

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Clopidogrel sulfate

Registration Number : 304MF10071

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

Initial Date of Registration : 2022-05-12

Latest Date of Registration : 2023-09-06

Metrochem

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Clopidogrel sulfate

Registration Number : 226MF10034

Registrant's Address : 326 Yokamachi, Toyama City, Toyama Prefecture

Initial Date of Registration : 2014-02-05

Latest Date of Registration : 2024-05-15

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Clopidogrel sulfate

Registration Number : 301MF10039

Registrant's Address : 9FL, KyungDong Pharm Bldg, 1926, Nambusunhwan-ro, Gwanak-gu, Seoul, Republic of Korea

Initial Date of Registration : 2019-08-09

Latest Date of Registration : 2019-08-09

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Clopidogrel sulfate

Registration Number : 302MF10107

Registrant's Address : 9FL, KyungDong Pharm Bldg, 1926, Nambusunhwan-ro, Gwanak-gu, Seoul, Republic of Korea

Initial Date of Registration : 2020-09-01

Latest Date of Registration : 2020-09-01

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Clopidogrel sulfate

Registration Number : 306MF10113

Registrant's Address : 3F SMART-K Bldg. B, 26, Gwacheon-daero 7-gil, Gwacheon-si, Gyeonggi-do, Republic of K...

Initial Date of Registration : 2024-08-22

Latest Date of Registration : 2024-08-22

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Clopidogrel sulfate (for manufacturing purposes only)

Registration Number : 226MF10032

Registrant's Address : 1-1-2 Nishinomiyahama, Nishinomiya City, Hyogo Prefecture

Initial Date of Registration : 2014-02-05

Latest Date of Registration : 2025-09-17

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Clopidogrel sulfate

Registration Number : 228MF10164

Registrant's Address : 121 Wausan-ro, Mapo-gu, Seoul, Korea

Initial Date of Registration : 2016-08-19

Latest Date of Registration : 2016-08-19

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KDMF

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

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Clopidogrel hydrogen sulfate

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...

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Clopidogrel hydrogen sulfate

Registrant Name : JL Bio Co., Ltd.

Registration Date : 2022-06-17

Registration Number : 20210715-129-H-390-56(1)

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

Manufacturer Address : CTO-Unit-V, Peddadevulapally Village, Tripuraram Mandal, Nalgonda District, Telangana...

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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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Clopidogrel hydrogen sulfate

Registrant Name : Agerson Bio Co., Ltd.

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...

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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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Clopidogrel hydrogen sulfate

Registrant Name : Farmist Co., Ltd.

Registration Date : 2022-09-19

Registration Number : 20210715-129-H-390-56(2)

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

Manufacturer Address : CTO-Unit-V, Peddadevulapally Village, Tripuraram Mandal, Nalgonda District, Telangana...

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Clopidogrel hydrogen sulfate

Registrant Name : Teragen Etex Co., Ltd.

Registration Date : 2022-09-19

Registration Number : 20210715-129-H-390-56(3)

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

Manufacturer Address : CTO-Unit-V, Peddadevulapally Village, Tripuraram Mandal, Nalgonda District, Telangana...

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Clopidogrel hydrogen sulfate

Registrant Name : MPK Korea Co., Ltd.

Registration Date : 2020-03-18

Registration Number : 20110225-129-H-88-15(14)

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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Clopidogrel sulfate

Registrant Name : Husid Co., Ltd.

Registration Date : 2023-02-13

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

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Clopidogrel sulfate

Registrant Name : Pharma Solution 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...

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Listed Suppliers

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

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Clopidogrel

About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...

Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale
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Virtual BoothIOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.

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Clopidogrel Bisulfate

About the Company : IOL Chemicals and Pharmaceuticals Limited, with over three decades of experience, is an innovation-driven company specializing in bulk drugs, intermediates, and specialty chemicals...

IOL Chemicals and Pharmaceuticals Limited, with over three decades of experience, is an innovation-driven company specializing in bulk drugs, intermediates, and specialty chemicals. As an API-based manufacturer, it offers economies of scale and cost advantages with substantial production capacity. Its API portfolio covers pain management, anti-diabetic, anti-hypertensive, and anti-convulsant categories. IOL Chemicals is backward-integrated, producing all intermediates and key starting materials for ibuprofen. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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EUROAPI

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

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Clopidogrel Hydrogen Sulfate

About the Company : EUROAPI focuses on reinventing active ingredient solutions to sustainably meet the needs of customers and patients worldwide. The company is a leading API player with a portfolio o...

EUROAPI focuses on reinventing active ingredient solutions to sustainably meet the needs of customers and patients worldwide. The company is a leading API player with a portfolio of around 200 products, covering a wide range of technologies and innovative molecules through CDMO activities. Supported by 3,650 employees, strong R&D capabilities, and six manufacturing sites in Europe, EUROAPI delivers high-quality API manufacturing to customers in more than 80 countries. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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LGM Pharma

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

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Clopidogrel

About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...

LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product CDMO, offering formulation, analytical method development and testing, regulatory support, and commercial manufacturing. Supported by a network of over 220 accredited cGMP manufacturing partners and more than 100,000 sq. ft. of FDA-inspected cGMP manufacturing and warehouse space, LGM delivers secure, end-to-end solutions across multiple dosage forms. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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Clopidogrel

About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
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Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

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Clopidogrel

About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...

Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and regulatory support, and strives for global standards. Known for quality and affordability, it has established a niche through innovative methods and exports to nearly every continent. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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Virtual BoothWith Virupaksha, you get a quality product with on-time delivery.

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Clopidogrel

About the Company : Virupaksha Organics, founded in 2003, is a leading manufacturer of APIs and intermediates. Its FDA-audited, ISO-certified facilities in Kazipally and Pashamylaram produce high-qual...

Virupaksha Organics, founded in 2003, is a leading manufacturer of APIs and intermediates. Its FDA-audited, ISO-certified facilities in Kazipally and Pashamylaram produce high-quality products. With 300+ customers in 100 countries, Virupaksha has built a strong global presence and a trusted reputation for reliability. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
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HRV Pharma

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Virtual BoothHRV Pharma - Market Expansion Leader in Pharmaceuticals.

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Clopidogrel

About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...

HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing, manufacturing, and supply services to support partners entering new markets worldwide. HRV Pharma works closely with major pharma and food additive companies and represents over 30 Indian drugmakers, primarily serving Europe, the US, and the Middle East. Headquartered in India, it operates offices in the US, Switzerland, Dubai, Lithuania, and Turkey. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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Virtual BoothOctavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

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Clopidogrel

About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 45 years of experience in formulation development, manufacturing, and commercialization. Its portfoli...

Octavius Pharma is a global leader in Directly Compressible Granules with over 45 years of experience in formulation development, manufacturing, and commercialization. Its portfolio includes DC granules, herbal and food supplements, APIs, and finished formulations such as tablets, capsules, syrups, and ointments. With WHO-GMP certification and a DSIR-certified R&D center, the company ensures quality and innovation, exporting to LATAM, the Middle East, Africa, Asia, and CIS regions, and offering formulation and marketing support. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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Virtual BoothTenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.

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Clopidogrel

About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...

Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opportunities grew, it was felt that the proprietorship firm had outlived its usefulness and that it needed a corporate structure. So, Tenatra Exports Private Limited was incorporated in 2002. Since then, the company has come a long way, gaining valuable experience and knowledge in the fields of chemicals and pharmaceuticals in India. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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DRUG PRODUCT COMPOSITIONS

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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

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PharmaCompass offers a list of Clopidogrel API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, 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.

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, and COA 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, and COA 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, 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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