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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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HRV Global Life Sciences
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USDMF

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01

PharmaVenue
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  • WHO-GMP

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

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 14809

Submission : 2000-03-31

Status : Active

Type : II

Sanofi Company Banner

02

PharmaVenue
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

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

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 12460

Submission : 1997-04-08

Status : Inactive

Type : II

Sanofi Company Banner

03

PharmaVenue
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

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

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 12439

Submission : 1997-03-06

Status : Inactive

Type : II

Sanofi Company Banner

04

PharmaVenue
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

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

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 14849

Submission : 2000-05-04

Status : Inactive

Type : II

Sanofi Company Banner

05

PharmaVenue
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  • fda
  • EDQM
  • WHO-GMP

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

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 34334

Submission : 2020-02-05

Status : Active

Type : II

Metrochem

06

  • fda
  • EDQM
  • WHO-GMP

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

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GDUFA

DMF Review : Complete

Rev. Date : 2013-01-30

Pay. Date : 2013-01-04

DMF Number : 16090

Submission : 2002-08-07

Status : Active

Type : II

Dr Reddy Company Banner

07

  • fda
  • EDQM
  • WHO-GMP

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

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GDUFA

DMF Review : Complete

Rev. Date : 2022-02-15

Pay. Date : 2022-01-11

DMF Number : 35506

Submission : 2020-12-30

Status : Active

Type : II

Dr Reddy Company Banner

08

PharmaVenue
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  • fda
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  • WHO-GMP

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

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 36534

Submission : 2022-06-16

Status : Active

Type : II

IOL Chemicals

09

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Virtual BoothTAPI offers customized CDMO Solutions for API development and manufacturing services.

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GDUFA

DMF Review : Complete

Rev. Date : 2012-11-29

Pay. Date : 2012-11-13

DMF Number : 17009

Submission : 2003-12-05

Status : Active

Type : II

TAPI Company Banner

10

PharmaVenue
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Listed Suppliers

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01

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Virtual BoothOctavius 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 40 years of experience in Formulation development, manufacturing and commercialization. It offers a w...

Octavius Pharma is a global leader in Directly Compressible Granules with over 40 years of experience in Formulation development, manufacturing and commercialization. It offers a wide range of products such as tablets, capsules, syrups and ointments. Its portfolio includes finished dosage formulations, herbal/food supplements and APIs. It exports bulk drugs, finished formulations and APIs, while maintaining quality in compliance with WHO GMP norms. With an experienced team, Octavius Pharma provides consulting services for formulation development and marketing. Octavius exports to LATAM, Middle East, African, Asian and CIS countries.
Octavius Pharma

02

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Virtual BoothAptra Synthesis produces APIs, Pellets (Semi-finished Formulations), and Intermediates.

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Clopidogrel

About the Company : Aptra Synthesis Private Limited, is a reliable and vertically integrated manufacturer of APIs and intermediates, boasting state-of-the-art manufacturing facilities that adhere to G...

Aptra Synthesis Private Limited, is a reliable and vertically integrated manufacturer of APIs and intermediates, boasting state-of-the-art manufacturing facilities that adhere to GMP standards. We take great pride in producing top-notch intermediates through our fully backward-integrated process. Aptra Synthesis Private Limited (ASPL) stands as one of the rapidly emerging manufacturers of Active Pharmaceutical Ingredients (APIs), Pellets (Semi-finished Formulations), and Intermediates.
Aptra Synthesis

03

EUROAPI

France
  • fda
  • EDQM
  • WHO-GMP

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 is the market leader in small molecule APIs with projected sales of about €1 billion in 2022. With around 200 APIs, it has one of the largest portfolios in the market. Th...

EUROAPI is the market leader in small molecule APIs with projected sales of about €1 billion in 2022. With around 200 APIs, it has one of the largest portfolios in the market. Thanks to its excellent R&D skills and six manufacturing facilities across Europe, EUROAPI guarantees API manufacturing of the highest quality to its clients in over 80 countries. Its strong innovation and R&D skills helps it to speed the development of more complex molecule segments through CDMO operations. It also offers experience in supply, regulation and quality. EUROAPI employs 3,350 people and is listed on Euronext.
EUROAPI Compnay Banner

04

LGM Pharma

U.S.A
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PharmaVenue
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  • fda
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  • WHO-GMP

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 hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
LGM Pharma CB

05

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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 ...

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
Metrochem

06

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  • EDQM
  • WHO-GMP

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
Dr Reddy Company Banner

07

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

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Clopidogrel

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

With a history spanning over three decades, IOL Chemicals and Pharmaceuticals Limited is an innovation-driven company that specializes in bulk drugs, intermediates and specialty chemicals. As an API-based company, IOL Chemicals has substantial manufacturing capacities that provide economies of scale and cost advantages. It also has extensive expertise in specialty chemicals. IOL Chemicals’ API portfolio includes various therapeutic categories such as pain management, anti-diabetic, anti-hypertensive and anti-convulsant. IOL Chemicals is a backward-integrated company that produces all intermediates and key starting materials for ibuprofen.
IOL Chemicals

08

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PharmaVenue
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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 was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...

Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete sourcing solutions for pharmaceutical products from India, including technical and regulatory assistance. It believes in providing its customers with high-quality products at reasonable prices. It has always endeavored to achieve global standards in the field of pharmaceuticals and has carved out a niche for itself through new methods based on current market needs. Today, it has established itself as a truly global company, with exports to almost every continent.
Jai Radhe Sales

09

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

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Clopidogrel

About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
HRV Global Life Sciences

10

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PharmaVenue
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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 Bisulfate

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 Chemie Private Limited (TCPL) 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.
Tenatra
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API Reference Price

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REDDY\\'S LABORATORIES","supplierCountry":"INDIA","foreign_port":"JAKARTA SOEKARNO-HA","customer":"PT.TATARASA PRIMATAMA","customerCountry":"INDONESIA","quantity":"130.00","actualQuantity":"130","unit":"KGS","unitRateFc":"313.1","totalValueFC":"41204","currency":"USD","unitRateINR":23181.01923076923,"date":"04-Jan-2021","totalValueINR":"3013532.5","totalValueInUsd":"41204","indian_port":"HYDERABAD AIR","hs_no":"29331999","bill_no":"7663805","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"INDONESIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"7-1-27, AMEERPET, HYDERABAD, ANDHRA PRADESH","customerAddress":""},{"dataSource":"API Export","activeIngredients":"CLOPIDOGREL BISULPHATE","year":"2021","qtr":"Q1","strtotime":1609698600,"product":"DRUG & DRUG INTERMEDIATES: CLOPIDOGREL B","address":"MAHENDRA INDL.ESTATE,III FLR.,PLOTNO.109-D,ROAD NO.29,SION(E)","city":"MUMBAI ,MAHARASHTRA","supplier":"AARTI PHARMALABS","supplierCountry":"INDIA","foreign_port":"MANILA","customer":"DEUTSCHE BANK","customerCountry":"PHILIPPINES","quantity":"300.00","actualQuantity":"300","unit":"KGS","unitRateFc":"64","totalValueFC":"18499.6","currency":"USD","unitRateINR":4510,"date":"04-Jan-2021","totalValueINR":"1353000","totalValueInUsd":"18499.6","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"7667823","productDescription":"Intermediate","marketType":"LESS REGULATED MARKET","country":"PHILIPPINES","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"MAHENDRA INDL.ESTATE,III FLR.,PLOTNO.109-D,ROAD NO.29,SION(E), MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"CLOPIDOGREL BESYLATE","year":"2021","qtr":"Q1","strtotime":1609698600,"product":"CLOPIDOGREL BESYLATE (IN-HOUSE) (OTHER O RGANIC COMPOUNDS) BATCH NO.: CPB200136 1 37 138 139 140 141 & 142","address":"SCF.287, MOTOR MARKET,MANIMAJRA,","city":"CHANDIGARH.","supplier":"SAURAV CHEMICALS","supplierCountry":"INDIA","foreign_port":"PIRAEUS","customer":"THE MANAGER","customerCountry":"GREECE","quantity":"2335.58","actualQuantity":"2335.58","unit":"KGS","unitRateFc":"117.8","totalValueFC":"278584.9","currency":"USD","unitRateINR":8723.6662413618888,"date":"04-Jan-2021","totalValueINR":"20374820.4","totalValueInUsd":"278584.9","indian_port":"JNPT","hs_no":"29420090","bill_no":"7654917","productDescription":"API","marketType":"REGULATED MARKET","country":"GREECE","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"SCF.287, MOTOR MARKET,MANIMAJRA,, CHANDIGARH.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"CLOPIDOGREL BISULPHATE","year":"2021","qtr":"Q1","strtotime":1609785000,"product":"CLOPIDOGREL BISULPHATE FORM 1 USP (SL NO :1498 OF APPENDIX 3B- MEIS)","address":"7-1-27, AMEERPET","city":"HYDERABAD, ANDHRA PRADESH","supplier":"DR. REDDY\\'S LABORATORIES","supplierCountry":"INDIA","foreign_port":"TIANJIN","customer":"TIANJIN J&K LIMITED","customerCountry":"CHINA","quantity":"2985.00","actualQuantity":"2985","unit":"KGS","unitRateFc":"223.3","totalValueFC":"674753.3","currency":"USD","unitRateINR":16532.437500837521,"date":"05-Jan-2021","totalValueINR":"49349325.94","totalValueInUsd":"674753.3","indian_port":"HYDERABAD ICD","hs_no":"29331999","bill_no":"7695772","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD ICD","supplierAddress":"7-1-27, AMEERPET, HYDERABAD, ANDHRA PRADESH","customerAddress":""},{"dataSource":"API Export","activeIngredients":"CLOPIDOGREL BISULPHATE","year":"2021","qtr":"Q1","strtotime":1609785000,"product":"CLOPIDOGREL BISULPHATE FORM 1 USP (SL NO :1498 OF APPENDIX 3B- MEIS)","address":"7-1-27, AMEERPET","city":"HYDERABAD, ANDHRA PRADESH","supplier":"DR. 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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":1731263400,"product":"CGB00\/51131709,CLOPIDOGREL BISULFATE LOTE CGBF000780 & CGBF000781 (PHARMACEUTICAL PRODUCTS)","address":"SITE NO.1,BOMMASANDRA INDL.AREA,IV","city":"ANEKAL TALUK,BANGALORE","supplier":"APOTEX INC","supplierCountry":"MEXICO","foreign_port":"MEXICO CITY","customer":"APOTEX INC","customerCountry":"INDIA","quantity":"574.83","actualQuantity":"574.83","unit":"KGS","unitRateFc":"280","totalValueFC":"162500.8","currency":"USD","unitRateINR":"23856","date":"11-Nov-2024","totalValueINR":"13713144.48","totalValueInUsd":"162500.8","indian_port":"Bangalore Air","hs_no":"29339990","bill_no":"6605042","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MEXICO","selfForZScoreResived":"Pharma Grade","supplierPort":"MEXICO CITY","supplierAddress":"AV INDUSTRIA AUTOMOTRIZ NO 301 50071 TOLUCA EDO DE MEXICO CP 50071 ESTADO DE MEXICO MX","customerAddress":"SITE NO.1,BOMMASANDRA INDL.AREA,IV"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731436200,"product":"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":"1162.03","actualQuantity":"1162.03","unit":"KGS","unitRateFc":"268","totalValueFC":"314419.9","currency":"USD","unitRateINR":"22833.6","date":"13-Nov-2024","totalValueINR":"26533328.21","totalValueInUsd":"314419.9","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"6650146","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":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":"581.68","actualQuantity":"581.68","unit":"KGS","unitRateFc":"268","totalValueFC":"157139.7","currency":"USD","unitRateINR":"22954.2","date":"10-Dec-2024","totalValueINR":"13351999.06","totalValueInUsd":"157139.7","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":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"}]
02-Jan-2021
31-Dec-2024
KGS
overview
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country Total Quantity
(KGS)
Average Price
(USD/KGS)
Number of Transactions

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Drugs in Development

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Details:

Roseday CV (rosuvastatin + clopidogrel) is a fixed dose combination which is approved for the treatment of cardiac diseases like heart attack, angina & stroke.


Lead Product(s): Rosuvastatin,Clopidogrel

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Roseday CV

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 24, 2023

USV Private Limited

01

PharmaVenue
Not Confirmed

Lead Product(s) : Rosuvastatin,Clopidogrel

Therapeutic Area : Cardiology/Vascular Diseases

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Roseday CV (rosuvastatin + clopidogrel) is a fixed dose combination which is approved for the treatment of cardiac diseases like heart attack, angina & stroke.

Brand Name : Roseday CV

Molecule Type : Small molecule

Upfront Cash : Not Applicable

August 24, 2023

USV Private Limited

Details:

ASD-002 (clopidogrel) being developed by EmulSol nanotechnology has been used to develop a novel nanoemulsion IV formulation for clopidogrel that has received Investigational New Drug (IND) approval for Acute Coronary Syndrome.


Lead Product(s): Clopidogrel

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: ASD-002

Study Phase: IND EnablingProduct Type: Small molecule

Sponsor: AcuteBio

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 23, 2023

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02

PharmaVenue
Not Confirmed
PharmaVenue
Not Confirmed

Details : ASD-002 (clopidogrel) being developed by EmulSol nanotechnology has been used to develop a novel nanoemulsion IV formulation for clopidogrel that has received Investigational New Drug (IND) approval for Acute Coronary Syndrome.

Brand Name : ASD-002

Molecule Type : Small molecule

Upfront Cash : Not Applicable

June 23, 2023

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Details:

Notably, a non-randomized, case-controlled, investigator sponsored proof of concept study evaluating AGGRASTAT® in combination with standard of care in patients with severe COVID-19 and hypercoagulability found that enhanced platelet inhibition improves hypoxemia.


Lead Product(s): Tirofiban,Clopidogrel,Aspirin

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Aggrastat

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 24, 2020

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03

Medicure

Canada
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PharmaVenue
Not Confirmed

Medicure

Canada
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PharmaVenue
Not Confirmed

Details : Notably, a non-randomized, case-controlled, investigator sponsored proof of concept study evaluating AGGRASTAT® in combination with standard of care in patients with severe COVID-19 and hypercoagulability found that enhanced platelet inhibition improves...

Brand Name : Aggrastat

Molecule Type : Small molecule

Upfront Cash : Not Applicable

August 24, 2020

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FDF Dossiers

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01

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

Flag India
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Regulatory Info :

Registration Country : India

Clopidogrel

Brand Name :

Dosage Form : Tablet

Dosage Strength : 75MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Octavius Pharma

02

  • fda
  • EDQM
  • WHO-GMP

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

Flag India
Digital Content Digital Content

Regulatory Info : DMF Available|FDF Compliance-USP

Registration Country : India

Clopidogrel

Brand Name :

Dosage Form : DC Granules

Dosage Strength : 75MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : DMF Available|FDF Compliance-USP

Registration Country : India

Octavius Pharma

03

  • fda
  • EDQM
  • WHO-GMP

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

Flag India
Digital Content Digital Content

Regulatory Info : DMF Available|FDF Compliance-USP

Registration Country : India

Clopidogrel

Brand Name :

Dosage Form : DC Granules

Dosage Strength : 150MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : DMF Available|FDF Compliance-USP

Registration Country : India

Octavius Pharma

04

  • fda
  • EDQM
  • WHO-GMP

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

Flag India
Digital Content Digital Content

Regulatory Info : DMF Available|FDF Compliance-USP

Registration Country : India

Clopidogrel

Brand Name :

Dosage Form : DC Granules

Dosage Strength : 300MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : DMF Available|FDF Compliance-USP

Registration Country : India

Octavius Pharma

05

Sanofi

France
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PharmaVenue
Not Confirmed
  • 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

Regulatory Info : RX

Registration Country : USA

CLOPIDOGREL BISULFATE

Brand Name : PLAVIX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 75MG BASE

Packaging :

Approval Date : 1997-11-17

Application Number : 20839

Regulatory Info : RX

Registration Country : USA

Sanofi Company Banner

06

Sanofi

France
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PharmaVenue
Not Confirmed
  • 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

Regulatory Info :

Registration Country : Sweden

klopidogrelvätesulfat

Brand Name : Clopidogrel Zentiva

Dosage Form : FILM COATED PILL

Dosage Strength : 75 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Sanofi Company Banner

07

Sanofi

France
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PharmaVenue
Not Confirmed
  • 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

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

Sanofi

France
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PharmaVenue
Not Confirmed
  • 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

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

Sanofi

France
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PharmaVenue
Not Confirmed
  • 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

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

Sanofi

France
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PharmaVenue
Not Confirmed
  • 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

Regulatory Info :

Registration Country : Canada

CLOPIDOGREL (CLOPIDOGREL BISULFATE)

Brand Name : PLAVIX

Dosage Form : TABLET

Dosage Strength : 75MG

Packaging : 28/500

Approval Date :

Application Number : 2238682

Regulatory Info :

Registration Country : Canada

Sanofi Company Banner
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FDA Orange Book

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01

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PharmaVenue
Not Confirmed
  • 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

Sanofi Company Banner

02

arrow
PharmaVenue
Not Confirmed
  • 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 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
  • fda
  • EDQM
  • WHO-GMP

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

ACCORD HLTHCARE

United Kingdom
PharmaVenue
Not Confirmed
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ACCORD HLTHCARE

United Kingdom
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PharmaVenue
Not Confirmed

CLOPIDOGREL BISULFATE

Brand Name : CLOPIDOGREL BISULFATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 75MG BASE

Approval Date : 2013-03-27

Application Number : 202925

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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05

ACTAVIS TOTOWA

Ireland
PharmaVenue
Not Confirmed
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ACTAVIS TOTOWA

Ireland
arrow
PharmaVenue
Not Confirmed

CLOPIDOGREL BISULFATE

Brand Name : CLOPIDOGREL BISULFATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 75MG BASE

Approval Date : 2013-05-28

Application Number : 90307

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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06

PharmaVenue
Not Confirmed
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PharmaVenue
Not Confirmed

CLOPIDOGREL BISULFATE

Brand Name : CLOPIDOGREL BISULFATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 75MG BASE

Approval Date : 2023-12-08

Application Number : 203632

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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07

CHARTWELL RX

U.S.A
PharmaVenue
Not Confirmed
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CHARTWELL RX

U.S.A
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PharmaVenue
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 :

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08

PharmaVenue
Not Confirmed
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PharmaVenue
Not Confirmed

CLOPIDOGREL BISULFATE

Brand Name : CLOPIDOGREL BISULFATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 75MG BASE

Approval Date : 2014-02-10

Application Number : 202928

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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09

PharmaVenue
Not Confirmed
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PharmaVenue
Not Confirmed

CLOPIDOGREL BISULFATE

Brand Name : CLOPIDOGREL BISULFATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 75MG BASE

Approval Date : 2020-07-17

Application Number : 213351

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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10

PharmaVenue
Not Confirmed
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PharmaVenue
Not Confirmed

CLOPIDOGREL BISULFATE

Brand Name : CLOPIDOGREL BISULFATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 300MG BASE

Approval Date : 2020-07-17

Application Number : 213351

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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Europe

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01

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Not Confirmed
  • 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

Regulatory Info :

Registration Country : Sweden

klopidogrelvätesulfat

Brand Name : Clopidogrel Zentiva

Dosage Form : FILM COATED PILL

Dosage Strength : 300 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Sanofi Company Banner

02

arrow
PharmaVenue
Not Confirmed
  • 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

Regulatory Info :

Registration Country : Sweden

klopidogrelvätesulfat

Brand Name : Plavix

Dosage Form : FILM COATED PILL

Dosage Strength : 75 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Sanofi Company Banner

03

arrow
PharmaVenue
Not Confirmed
  • 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

Regulatory Info :

Registration Country : Italy

Clopidogrel

Brand Name : Clopidogrel

Dosage Form : Clopidogrel 75Mg 28 Combined Oral Use

Dosage Strength : 28 cpr riv 75 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Sanofi Company Banner

04

arrow
PharmaVenue
Not Confirmed
  • 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

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

Sanofi Company Banner

05

arrow
PharmaVenue
Not Confirmed
  • 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

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

Sanofi Company Banner

06

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PharmaVenue
Not Confirmed
  • 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

Regulatory Info :

Registration Country : Norway

Clopidogrel

Brand Name : Plavix

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 75 mg

Packaging : Blister, endose

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Sanofi Company Banner

07

arrow
PharmaVenue
Not Confirmed
  • 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

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

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Clopidogrel

Brand Name : Plavix

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 75 mg

Packaging : Blister

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Registration Country : Norway

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Helvepharm AG

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Registration Country : Switzerland

Clopidogrelum

Brand Name : Clopidogrel Zentiva

Dosage Form : Filmtabl

Dosage Strength : 75mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Clopidogrelum

Brand Name : Plavix

Dosage Form : Tabl

Dosage Strength : 75mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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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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DATA COMPILATION #PharmaFlow

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DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions
Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024.  Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent.  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each.  The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders).  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available)    GDUFA fee for FY 2025: The FDA’s Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453   US$ 3,21,920   Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427   US$ 2,31,952 FDF—Foreign US$ 2,35,427   US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629   US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852   US$ 7,56,666 Small business generic drug applicant US$ 1,72,963   US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.   

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https://www.pharmacompass.com/radio-compass-blog/dmf-filings-hit-all-time-high-in-q3-2024-china-tops-list-with-58-increase-in-type-ii-submissions

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24 Oct 2024

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Clopidogrel Bisulfate

Drug Cost (USD) : 200,676,447

Year : 2022

Prescribers : 3178494

Prescriptions : 12828367

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Clopidogrel Bisulfate

Drug Cost (USD) : 7,872,337

Year : 2022

Prescribers : 3868

Prescriptions : 16661

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Clopidogrel Bisulfate

Drug Cost (USD) : 158,314,799

Year : 2021

Prescribers : 3138628

Prescriptions : 12930126

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Clopidogrel Bisulfate

Drug Cost (USD) : 8,672,716

Year : 2021

Prescribers : 4533

Prescriptions : 20038

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Clopidogrel Bisulfate

Drug Cost (USD) : 9,804,827

Year : 2020

Prescribers : 5648

Prescriptions : 26044

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Clopidogrel Bisulfate

Drug Cost (USD) : 184,677,108

Year : 2020

Prescribers : 3085966

Prescriptions : 13402749

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Clopidogrel Bisulfate

Drug Cost (USD) : 187,965,459

Year : 2019

Prescribers : 3095098

Prescriptions : 13736319

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Company :

Clopidogrel Bisulfate

Drug Cost (USD) : 11,359,796

Year : 2019

Prescribers : 6794

Prescriptions : 32487

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Company :

Clopidogrel Bisulfate

Drug Cost (USD) : 182,729,179

Year : 2018

Prescribers : 3023485

Prescriptions : 14256417

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Company :

Clopidogrel Bisulfate

Drug Cost (USD) : 13,313,914

Year : 2018

Prescribers : 8102

Prescriptions : 41233

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ABOUT THIS PAGE

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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