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Chemistry

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Also known as: Timnodonic acid, Icosapent, 10417-94-4, Icosapentaenoic acid, Epa, Cis-5,8,11,14,17-eicosapentaenoic acid

Molecular Formula

C₂₀H₃₀O₂

Molecular Weight

302.5 g/mol

InChI Key

JAZBEHYOTPTENJ-JLNKQSITSA-N

FDA UNII

AAN7QOV9EA

Important polyunsaturated fatty acid found in fish oils. It serves as the precursor for the prostaglandin-3 and thromboxane-3 families. A diet rich in eicosapentaenoic acid lowers serum lipid concentration, reduces incidence of cardiovascular disorders, prevents platelet aggregation, and inhibits arachidonic acid conversion into the thromboxane-2 and prostaglandin-2 families.

1 2D Structure

Icosapent Ethyl

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(5Z,8Z,11Z,14Z,17Z)-icosa-5,8,11,14,17-pentaenoic acid

2.1.2 InChI

InChI=1S/C20H30O2/c1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-18-19-20(21)22/h3-4,6-7,9-10,12-13,15-16H,2,5,8,11,14,17-19H2,1H3,(H,21,22)/b4-3-,7-6-,10-9-,13-12-,16-15-

2.1.3 InChI Key

JAZBEHYOTPTENJ-JLNKQSITSA-N

2.1.4 Canonical SMILES

CCC=CCC=CCC=CCC=CCC=CCCCC(=O)O

2.1.5 Isomeric SMILES

CC/C=C\C/C=C\C/C=C\C/C=C\C/C=C\CCCC(=O)O

2.2 Other Identifiers

2.2.1 UNII

AAN7QOV9EA

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 5,8,11,14,17-eicosapentaenoic Acid

2. 5,8,11,14,17-icosapentaenoic Acid

3. Acid, Eicosapentanoic

4. Eicosapentanoic Acid

5. Icosapent

6. Omega 3 Eicosapentaenoic Acid

7. Omega-3-eicosapentaenoic Acid

8. Timnodonic Acid

2.3.2 Depositor-Supplied Synonyms

1. Timnodonic Acid

2. Icosapent

3. 10417-94-4

4. Icosapentaenoic Acid

5. Epa

6. Cis-5,8,11,14,17-eicosapentaenoic Acid

7. (5z,8z,11z,14z,17z)-icosa-5,8,11,14,17-pentaenoic Acid

8. Icosapento

9. Icosapentum

10. 5,8,11,14,17-eicosapentaenoic Acid

11. Eicosapentaenoate

12. 5z,8z,11z,14z,17z-eicosapentaenoic Acid

13. (all-z)-5,8,11,14,17-eicosapentaenoic Acid

14. Icosapent [inn]

15. (5z,8z,11z,14z,17z)-5,8,11,14,17-eicosapentaenoic Acid

16. 5,8,11,14,17-icosapentaenoic Acid

17. Ropufa 70

18. Ccris 3279

19. Incromega E 7010sr

20. Aan7qov9ea

21. (5z,8z,11z,14z,17z)-icosapentaenoic Acid

22. (5z,8z,11z,14z,17z)-eicosapentaenoic Acid

23. Omega-3-carboxylic Acids

24. Epa 45g

25. Chembl460026

26. (5z,8z,11z,14z,17z)-eicosapentaenoate

27. All-cis-5,8,11,14,17-icosapentaenoic Acid

28. Chebi:28364

29. All-cis-5,8,11,14,17-eicosapentaenoic Acid

30. All-cis-icosa-5,8,11,14,17-pentaenoic Acid

31. Icosapent (inn)

32. Cis-delta(5,8,11,14,17)-eicosapentaenoic Acid

33. 5,8,11,14,17-eicosapentaenoic Acid, (all-z)-

34. All-cis-fatty Acid 20:5 Omega-3

35. Eicosapentaenoic Acid (c20:5 N3)

36. Epa;timnodonic Acid

37. Icosapentaenoate

38. (all-z)-delta5,8,11,14,17-eicosapentaenoic Acid

39. C20:5n-3,6,9,12,15

40. Cis-5,8,11,14,17-epa

41. Fa 20:5

42. Ncgc00161344-03

43. C20:5 (n-3)

44. Eicosapentaenoic Acid (20:5 N-3)

45. Eicosa-5z,8z,11z,14z,17z-pentaenoic Acid (20:5, N-3)

46. Miraxion

47. Eicosapentanoic Acid

48. Eye Q

49. Eye-q

50. 5,8,11,14,17-eicosapentaenoic Acid, (5z,8z,11z,14z,17z)-

51. Epa [drug]

52. Unii-aan7qov9ea

53. 1553-41-9

54. Icosapentum [inn-latin]

55. Icosapento [inn-spanish]

56. (5z,8z,11z,14z,17z)-icosapentaenoate

57. Timnodonate

58. 3gwx

59. All Cis-5,8,11,14,17-eicosapentaenoic Acid

60. Mfcd00065716

61. All-cis-icosapentaenoate

62. All-cis-icosapentaenoic Acid

63. Dsstox_cid_21023

64. Dsstox_rid_79612

65. Dsstox_gsid_41023

66. Schembl20469

67. Bspbio_001328

68. Bml3-b01

69. Gtpl3362

70. Dtxsid9041023

71. Eicosapentaenoic Acid [mi]

72. Hms1361c10

73. Hms1791c10

74. Hms1989c10

75. Hms3402c10

76. Hms3649d19

77. Hy-b0660

78. Zinc4474603

79. 5,8,11,14,17-icosapentaenoate

80. Eicosapentaenoic Acid [inci]

81. Tox21_111991

82. 5,8,11,14,17-eicosapentaenoate

83. Bdbm50242349

84. Eicosapentaenoic Acid [vandf]

85. Lmfa01030759

86. S6476

87. Eicosapentaenoic Acid [mart.]

88. Akos027470327

89. Eicosapentaenoic Acid [usp-rs]

90. Eicosapentaenoic Acid [who-dd]

91. Ccg-207957

92. Ccg-208136

93. Db00159

94. Cis-5,8,11,14,17-eicosapentaenoate

95. Idi1_033798

96. Ncgc00161344-01

97. Ncgc00161344-02

98. Ncgc00161344-04

99. Ncgc00161344-07

100. 5z,8z,11z,14z,17z-eicosapentaenoate

101. Ac-31072

102. As-53730

103. Cas-10417-94-4

104. E0441

105. 5,8,11,14,17-eicosapentaenoic Acid (6ci)

106. All Cis-5,8,11,14,17-icosapentaenoic Acid

107. C06428

108. D08061

109. P16966

110. (all-cis)-5,8,11,14,17-eicosapentaenoic Acid

111. Eicosapentaenoic Acid (epa) (c20:5 N3)

112. L001256

113. Q409990

114. Sr-01000946647

115. Fa(20:5(5z,8z,11z,14z,17z))

116. J-001125

117. Sr-01000946647-1

118. Z,z,z,z,z-eicosa-5,8,11,14,17-pentaenoic Acid

119. (z,z,z,z,z)-5,8,11,14,17-eicosapentaenoic Acid

120. Brd-k47192521-001-02-1

121. Cis-5,8,11,14,17-eicosapentaenoic Acid, >=99%

122. 7f8bf016-b146-4f72-a52e-b9298ba3a9ab

123. C20h30o2 (cis-5,8,11,14,17-eicosapentaenoic Acid)

124. Eicosapentaenoic Acid, 5,8,11,14,17-(z,z,z,z,z)-

125. 5,8,11,14,17-eicosapentaenoic Acid, (all-z)- (8ci)

126. Cis-5,8,11,14,17-eicosapentaenoic Acid, >=85%, Liquid

127. Cis-5,8,11,14,17-eicosapentaenoic Acid, Analytical Standard

128. (5z,8z,11 Z,14z,17z)-icosa-5,8,11,14,17-pentaenoic Acid

129. (5z,8z,11z,14z,17z)-eicosa-5,8,11,14,17-pentaenoic Acid

130. Cis, Cis, Cis, Cis, Cis-eicosa-5,8,11,14,17-pentaenoic Acid

131. 5,8,11,14,17-eicosapentaenoic Acid, (5z,8z,11z,14z,17z)- (9ci)

132. Eicosapentaenoic Acid (epa) (c20:5) (constituent Of Krill Oil) [dsc]

133. Cis-5,8,11,14,17-eicosapentaenoic Acid, 500 Mug/ml In Ethanol, Certified Reference Material

2.4 Create Date

2005-03-26

3 Chemical and Physical Properties

Molecular Formula	C₂₀H₃₀O₂
Molecular Weight	302.5 g/mol
XLogP3	5.6
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	2
Rotatable Bond Count	13
Exact Mass	302.224580195 g/mol
Monoisotopic Mass	302.224580195 g/mol
Topological Polar Surface Area	37.3 Å²
Heavy Atom Count	22
Formal Charge	0
Complexity	398
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	5
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Indication

EPA can be used for lowering elevated triglycerides in those who are hyperglyceridemic. In addition, EPA may play a therapeutic role in patients with cystic fibrosis by reducing disease severity and may play a similar role in type 2 diabetics in slowing the progression of diabetic nephropathy.

FDA Label

OM3-CA is indicated as an adjunct to diet to reduce triglycerides levels in adults patients with severe hypertriglyceridemia (>500 mg/dL). The patients involved in this treatment should be laced with an appropriate lipid-lowering diet. Hypertriglyceridemia is defined as an elevated plasma triglyceride concentration. It is usually correlated to other secondary conditions such as poor diet, alcohol use, obesity, metabolic syndrome and type 2 diabetes.

FDA Label

Treatment of Familial Adenomatous Polyposis

Treatment of dyslipidaemia

5 Pharmacology and Biochemistry

5.1 Pharmacology

Eicosanoids are chemical messengers derived from 20-carbon polyunsaturated fatty acids that play critical roles in immune and inflammatory responses. Both 20-carbon omega-6 fatty acids (arachidonic acid) and 20-carbon omega-3 fatty acids (EPA) can be found in cell membranes. During an inflammatory response, arachidonic acid and EPA are metabolized by enzymes known as cyclooxygenases and lipoxygenases to form eicosanoids. Increasing omega-3 fatty acid intake increases the EPA content of cell membranes and decreases the arachidonic acid content, resulting in higher proportions of eicosanoids derived from EPA. Physiologic responses to arachidonic acid-derived eicosanoids differ from responses to EPA-derived eicosanoids. In general, eicosanoids derived from EPA are less potent inducers of inflammation, blood vessel constriction, and clotting than eicosanoids derived from arachidonic acid.

OM3-CA is very effective in reducing triglyceride levels. After 14 days of treatment, it is possible to observe even a 21% reduction. The reduction of the triglycerides could reach even to 25% in cases with the maximal used concentration of 4 g.

5.2 Absorption, Distribution and Excretion

Absorption

When compared to omega-3 -acid ethyl esters, OM3-CA present a 4-fold higher bioavailability. OM3-CA is absorbed directly in the small intestine and the maximal plasma concentration is reached between 4.5-5 hours after initial administration. The absorbed dosage is transferred to the general circulation via the lymphatic system and distributed within tissues throughout the body. The absorption speed and extent is highly promoted by the bile. In preclinical studies performed in dogs, the Cmax, tmax and AUC were reported to be 15.1 mcg/ml, 24 hours and 1210.3 mcg.h/ml, respectively.

Route of Elimination

OM3-CA does not go under renal excretion. After the metabolism, all the dose is excreted as CO2 and water in the form of expelled air and the rest is excreted in feces.

Volume of Distribution

This pharmacokinetic property is not available.

Clearance

The registered clearance rate at steady-state is of 548 ml/h for eicosapentaenoic acid and 518 ml/h for docohexaenoic acid.

5.3 Metabolism/Metabolites

OM3-CA is metabolized in the liver following the normal fatty acid oxidation. Once absorbed, they are incorporated into triglycerides, cholesterol esters and phospholipids in tissues. The metabolism is marked by beta-oxidation followed by tricarboxylic acid cycle. It is reported that OM3-CA is an inhibitor of several enzymes such as CYP2C9, CYP2C19 and to a lesser extent to CYP1A2, CYP2E1, CYP3A4. It is thought that the metabolism of OM3-CA is mainly done by CYP3A and CYP4F3B.

Eicosapentaenoic acid has known human metabolites that include Juniperonic acid.

S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560

5.4 Biological Half-Life

The half-life of OM3-CA depends on the type of component in which for eicosapentaenoic acid it is estimated to be of approximately 4.7-10.8 hours while for docosahexaenoic acid is reported to be of about 7 hours. The half-life of baseline-adjusted at steady-state is of 36 and 46 hours respectively for eicosapentaenoic acid and docosahexaenoic acid.

5.5 Mechanism of Action

The anti-inflammatory, antithrombotic and immunomodulatory actions of EPA is probably due to its role in eicosanoid physiology and biochemistry. Most eicosanoids are produced by the metabolism of omega-3 fatty acids, specifically, arachidonic acid. These eicosanoids, leukotriene B4 (LTB4) and thromboxane A2 (TXA2) stimulate leukocyte chemotaxis, platelet aggregation and vasoconstriction. They are thrombogenic and artherogenic. On the other hand, EPA is metabolized to leukotriene B5 (LTB5) and thromboxane A3 (TXA3), which are eicosanoids that promote vasodilation, inhibit platelet aggregation and leukocyte chemotaxis and are anti-artherogenic and anti-thrombotic. The triglyceride-lowering effect of EPA results from inhibition of lipogenesis and stimulation of fatty acid oxidation. Fatty acid oxidation of EPA occurs mainly in the mitochondria. EPA is a substrate for Prostaglandin-endoperoxide synthase 1 and 2. It also appears to affect the function and bind to the Carbohydrate responsive element binding protein (ChREBP) and to a fatty acid receptor (G-coupled receptor) known as GP40.

The reduction of the synthesis of triglycerides in the liver may be caused because the main components of OM3-CA, eicosapentaenoic acid, and docosahexaenoic acid, are poor substrates for the enzymes responsible for the synthesis of triglycerides. These two major components inhibit the esterification of other fatty acids. OM3-CA is also thought to enhance the clearance of triglycerides from the circulating very low-density lipoprotein particles by different potential effects such as inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase, increase in mitochondrial and peroxisomal beta-oxidation in the liver, decrease lipogenesis in the liver and increase lipoprotein lipase activity.

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ICOSAPENT ETHYL

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REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"1.30","actualQuantity":"1.3","unit":"KGS","unitRateFc":"350","totalValueFC":"549.2","currency":"USD","unitRateINR":"32197","date":"05-Mar-2022","totalValueINR":"41856.13","totalValueInUsd":"549.2","indian_port":"HYDERABAD AIR","hs_no":"29161990","bill_no":"7747087","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"H.NO. 8-2-337, BESIDE TV9 OFFICE, ROAD NO.3, BANJARA HILLS, Contact N"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1656181800,"product":"ICOSAPENT ETHYL","address":"407\/408 SHARDA CHAMBERS,NEW MARINE LINES","city":"MUMBAI,MAHARASHTRA","supplier":"AK & MN BIOFARM","supplierCountry":"KOREA, REPUBLIC OF","foreign_port":"NA","customer":"BDR PHARMACEUTICALS","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"250","totalValueFC":"1265","currency":"USD","unitRateINR":"19737.5","date":"26-Jun-2022","totalValueINR":"98687.5","totalValueInUsd":"1265","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"9286278","productDescription":"API","marketType":"REGULATED MARKET","country":"KOREA,REPUBLIC OF","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"407\/408 SHARDA CHAMBERS,NEW MARINE LINES"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1659637800,"product":"ICOSAPENT ETHYL (EICOSAPENTAENOIC ACID ETHYL ESTER (MAXOMEGATM EPA 96EE))(100 KG\/10 KG PER BOTTLE. 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REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"1.50","actualQuantity":"1.5","unit":"KGS","unitRateFc":"350","totalValueFC":"649.8","currency":"USD","unitRateINR":"35420","date":"02-Jan-2023","totalValueINR":"53129.97","totalValueInUsd":"649.8","indian_port":"BANGALORE AIR","hs_no":"29163990","bill_no":"4006633","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"H.NO. 8-2-337, BESIDE TV9 OFFICE, ROAD NO.3, BANJARA HILLS, Contact N"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1675967400,"product":"ICOSAPENT ETHYL LOT. NO L003240","address":"901-911 9TH FLR ISCON ELEGANCE NR SHAPATH 5 S G HIGHWAY Contact No: 9","city":"AHMEDABAD","supplier":"K.D. PHARMA BEXBACH GMBH","supplierCountry":"GERMANY","foreign_port":"NA","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"175","totalValueFC":"3506.8","currency":"USD","unitRateINR":"14481.3","date":"10-Feb-2023","totalValueINR":"289625","totalValueInUsd":"3506.8","indian_port":"BOMBAY AIR","hs_no":"29161990","bill_no":"4597001","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"901-911 9TH FLR ISCON ELEGANCE NR SHAPATH 5 S G HIGHWAY Contact No: 9"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1675967400,"product":"ICOSAPENT ETHYL LOT. NO L003253","address":"901-911 9TH FLR ISCON ELEGANCE NR SHAPATH 5 S G HIGHWAY Contact No: 9","city":"AHMEDABAD","supplier":"K.D. 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REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"30.00","actualQuantity":"30","unit":"KGS","unitRateFc":"331.8","totalValueFC":"11758.1","currency":"USD","unitRateINR":"32120.7","date":"21-Apr-2023","totalValueINR":"963620.54","totalValueInUsd":"11758.1","indian_port":"HYDERABAD AIR","hs_no":"29161990","bill_no":"5623223","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"H.NO. 8-2-337, BESIDE TV9 OFFICE, ROAD NO.3, BANJARA HILLS, Contact N"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1685903400,"product":"EPA 97% (ICOSAPENT ETHYL 97%)","address":"BASEMENT & GF PLOT NO-683,BLOCK-CW ,","city":"SANJAY GANDHI TRANSPORT NAGAR,DELHI","supplier":"KINOMEGA BIOPHARM INC.","supplierCountry":"CHINA","foreign_port":"NA","customer":"NUTRA ZONE","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"155","totalValueFC":"7863.5","currency":"USD","unitRateINR":"12927.3","date":"05-Jun-2023","totalValueINR":"646349.69","totalValueInUsd":"7863.5","indian_port":"BOMBAY AIR","hs_no":"29161990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"BASEMENT & GF PLOT NO-683,BLOCK-CW ,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1694457000,"product":"FOC ITEM \/ ETHYL ICOSAPENTATE OMEGA 3 FISH OIL - 1000 ML","address":"NO S 26 BOMMASANDRA INDUSTRIAL ARE","city":"BANGALORE,KARNATAKA","supplier":"NOVASEP","supplierCountry":"FRANCE","foreign_port":"N\/A","customer":"ALTHERA LABORATORIES INDIA ","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"368","totalValueFC":"406.8","currency":"EUR","unitRateINR":"33771.7","date":"12-Sep-2023","totalValueINR":"33771.7","totalValueInUsd":"406.8","indian_port":"Bangalore Air","hs_no":"29161990","bill_no":"7797721","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"N\/A","customerAddress":"NO S 26 BOMMASANDRA INDUSTRIAL ARE"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1694543400,"product":"ICOSAPENT ETHYL J.P. (CAS NO. 86227-47-6) (INV NO. BD090623E97D00E0190 DTD. 06.09.2023)","address":"407\/408,SHARDA CHAMBERS,","city":"MUMBAI, MAHARASHTRA.","supplier":"M\/S. AK & MN BIOFARM CO.,LTD","supplierCountry":"KOREA, REPUBLIC OF","foreign_port":"SEOUL - INCHEON INT\\'","customer":"BDR PHARMACEUTICALS","customerCountry":"INDIA","quantity":"190.00","actualQuantity":"190","unit":"KGS","unitRateFc":"150","totalValueFC":"28823.4","currency":"USD","unitRateINR":"12592.5","date":"13-Sep-2023","totalValueINR":"2392575","totalValueInUsd":"28823.4","indian_port":"Bombay Air","hs_no":"29162090","bill_no":"7810752","productDescription":"API","marketType":"REGULATED MARKET","country":"KOREA,REPUBLIC OF","selfForZScoreResived":"Pharma Grade","supplierPort":"SEOUL - INCHEON INT\\'","supplierAddress":"81, SANGGAE-RO, ULSAN CITYNAMGU PROVINCE (SOUTH KOREA)44787 KR","customerAddress":"407\/408,SHARDA CHAMBERS,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1694629800,"product":"ICOSAPENT ETHYL","address":"206, DEVAVRATA,","city":"NAVI MUMBAI, MAHARASHTRA.","supplier":"HUATAI PHARMA","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"STRIDES PHARMA SCIENCE","customerCountry":"INDIA","quantity":"40.00","actualQuantity":"40","unit":"KGS","unitRateFc":"156","totalValueFC":"6390.7","currency":"USD","unitRateINR":"13262","date":"14-Sep-2023","totalValueINR":"530481.09","totalValueInUsd":"6390.7","indian_port":"Bangalore Air","hs_no":"29420090","bill_no":"7836938","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"NO.37 SECTION 6, NORTH CHENGDU AVENUE, GUANGHAN, DEYANG CITY, SICHUANPROVINCE 618304 P.R CN","customerAddress":"206, DEVAVRATA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1707762600,"product":"ICOSAPENT ETHYL 97% (FOR LABORATORY RESEARCH)","address":"IRIS- 1004, KESAR GARDEN, PLOT NO.","city":"NAVI MUMBAI.","supplier":"KINOMEGA BIOPHARM INC.","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"V-ENSURE PHARMA TECHNOLOGIES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"220","totalValueFC":"1112.9","currency":"USD","unitRateINR":"18469","date":"13-Feb-2024","totalValueINR":"92345","totalValueInUsd":"1112.9","indian_port":"Bombay Air","hs_no":"29159099","bill_no":"2120625","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"No.161, South Yinghuashan Road, Shifang, Deyang City, Sichuan, China,618400 China","customerAddress":"IRIS- 1004, KESAR GARDEN, PLOT NO."},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1708626600,"product":"ICOSAPENT ETHYL (FOR R&D PURPOSE ONLY)","address":"IRIS- 1004, KESAR GARDEN, PLOT NO.","city":"NAVI MUMBAI.","supplier":"NOVASEP","supplierCountry":"FRANCE","foreign_port":"PARIS - CHARLES DE G","customer":"V-ENSURE PHARMA TECHNOLOGIES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"448","totalValueFC":"2447.2","currency":"EUR","unitRateINR":"40611.2","date":"23-Feb-2024","totalValueINR":"203056","totalValueInUsd":"2447.2","indian_port":"Bombay Air","hs_no":"29161990","bill_no":"2273653","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"PARIS - CHARLES DE G","supplierAddress":"AVENUE DU LAC, F-64150 MOURENXSDNFSDNF France","customerAddress":"IRIS- 1004, KESAR GARDEN, PLOT NO."},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1714156200,"product":"ICOSAPENT ETHYL","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"SHANDONG XINHUA PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"500","totalValueFC":"612.1","currency":"USD","unitRateINR":"51114.8","date":"27-Apr-2024","totalValueINR":"51114.75","totalValueInUsd":"612.1","indian_port":"Hyderabad Air","hs_no":"29161990","bill_no":"3227366","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"NO.1, LUTAI ROAD, HIGH-TECH DISTRICT, ZIBO, SHANDONG, P.R.CHINA, 255086 CHINA China","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719513000,"product":"ICOSAPENT ETHYL (EPA960EE)FOR TESTING PURPOSE","address":"NO.15, GOPALAKRISHNAN ROAD,","city":"CHENNAI","supplier":"CHEMPORT INC","supplierCountry":"REPUBLIC OF KOREA","foreign_port":"SEOUL - INCHEON INT\\'","customer":"MADRAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"189.00","actualQuantity":"189","unit":"KGS","unitRateFc":"150","totalValueFC":"29498.6","currency":"USD","unitRateINR":"13029.2","date":"28-Jun-2024","totalValueINR":"2462524.35","totalValueInUsd":"29498.6","indian_port":"Madras Air","hs_no":"29420090","bill_no":"4234394","productDescription":"API","marketType":"","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"SEOUL - INCHEON INT\\'","supplierAddress":"30-5 DONGSUNONGGONGDANJI-GILJEOLLANAM NAJU-SI58275 KR KOREA,REPUBLIC OF","customerAddress":"NO.15, GOPALAKRISHNAN ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731868200,"product":"ICOSAPENT ETHYL J.P (INV NO. BD111124E97D00E1520 DTD. 11.11.2024)","address":"407\/408,SHARDA CHAMBERS,","city":"MUMBAI, MAHARASHTRA.","supplier":"M\/S AK BIOPHARM CO LTD","supplierCountry":"REPUBLIC OF KOREA","foreign_port":"SEOUL - INCHEON INT\\'","customer":"BDR PHARMACEUTICALS","customerCountry":"INDIA","quantity":"1520.00","actualQuantity":"1520","unit":"KGS","unitRateFc":"113","totalValueFC":"173615.9","currency":"USD","unitRateINR":"9638.9","date":"18-Nov-2024","totalValueINR":"14651128","totalValueInUsd":"173615.9","indian_port":"Bombay Air","hs_no":"29162090","bill_no":"6733867","productDescription":"API","marketType":"","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"SEOUL - INCHEON INT\\'","supplierAddress":"81, SANGGAE-RO, NAM-GU UISAN 44787 REPLUBLIC OF KOREA KR","customerAddress":"407\/408,SHARDA CHAMBERS,"}]

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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FDA Orange Book

01

DR REDDYS

India

CPhI WW Frankfurt

Booth #9.1B48

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

Contact Supplier

India

Virtual Booth

Digital Content

RLD : No

TE Code : AB

ICOSAPENT ETHYL

Brand Name : ICOSAPENT ETHYL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 1GM

Approval Date : 2020-08-07

Application Number : 209499

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product Web Link

02

DR REDDYS

India

CPhI WW Frankfurt

Booth #9.1B48

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

Contact Supplier

India

Virtual Booth

Digital Content

RLD : No

TE Code : AB

ICOSAPENT ETHYL

Brand Name : ICOSAPENT ETHYL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 500MG

Approval Date : 2023-03-08

Application Number : 209499

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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08

ZYDUS LIFESCIENCES

India

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09

ZYDUS LIFESCIENCES

India

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10

STRIDES SOFTGELS

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Eicosapentaenoic Acid (10 kg) API needed in India [ENA18618]

A company that deals in various pharmaceutical products is looking for suppliers of Eicosapentaenoic Acid (10 kg) API for commercial purposes. The suppliers must support this enquiry with CoA.

15 Nov 2023

Icosapent Ethyl (MOQ) API needed in India [ENA18052]

A company that focuses on research, development and manufacturing of soft gel capsules is looking for suppliers of Icosapent Ethyl (MOQ) API for commercial purposes. The suppliers must support this enquiry with CoA.

16 Sep 2023

Eicosapentaenoic Acid (25 kg) API needed in India [ENA17910]

A company that focuses on the manufacturing of OSDs, gels, creams & lotions is looking for suppliers of Eicosapentaenoic Acid (25 kg) API for commercial purposes. The suppliers must support this enquiry with GMP & CoA.

29 Aug 2023

Icosapent Ethyl (1.2 MT) API needed in Egypt [ENA17458]

A company that focuses on the manufacturing, sales, marketing activities, import & export activities and distribution of pharmaceuticals is looking for suppliers of Icosapent Ethyl (1.2 MT) API for commercial purposes. The suppliers must support this enquiry with GMP & CoA.

04 Jul 2023

Icosapent Ethyl (96%) API needed in India [ENA17376]

A company that focuses on the development of innovative medicines is looking for suppliers of Icosapent Ethyl (96%) API for development purposes. The suppliers must support this enquiry with CEP, open part DMF & CoA.

22 Jun 2023

Eicosapentaenoic Acid API needed in India [ENA16539]

A company that deals in the distribution of various pharmaceutical products is looking for suppliers of Eicosapentaenoic Acid API for commercial purposes. The suppliers must support this enquiry with CoA.

06 Mar 2023

Icosapent Ethyl API needed in Bangladesh [ENA14788]

A company that focuses on manufacturing a range of finished formulations is looking for suppliers of Icosapent Ethyl API for development purpose. The suppliers must support this enquiry with open part DMF & CoA.

23 Aug 2022

USP Grade Icosapent Ethyl API needed in Bangladesh [ENA13785]

A company that deals in various pharmaceutical products is looking for suppliers of USP Grade Icosapent Ethyl API for commercial purpose. The suppliers must support this enquiry with GMP.

28 May 2022

Icosapent Ethyl API needed in Bangladesh [ENA12673]

A company that deals in the trading of various pharmaceutical products is looking for suppliers of Icosapent Ethyl API for commercial purpose. The suppliers must support this enquiry with CoA.

11 Feb 2022

Icosapent Ethyl API needed in the United States [ENA12426]

A company that provides consultancy services to the pharmaceutical industry in the area of formulation and process development is looking for suppliers of Icosapent Ethyl API for both development & commercial purpose. The suppliers must support this enquiry with USDMF, USFDA & CoA.

17 Jan 2022

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ABOUT THIS PAGE

Eicosapentaenoic Acid Manufacturers

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

Eicosapentaenoic Acid Suppliers

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

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

Eicosapentaenoic Acid USDMF

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

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

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

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

Eicosapentaenoic Acid KDMF

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

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

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

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

Eicosapentaenoic Acid GMP

Eicosapentaenoic Acid 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 Eicosapentaenoic Acid 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 Eicosapentaenoic Acid GMP manufacturer or Eicosapentaenoic Acid GMP API supplier for your needs.

Eicosapentaenoic Acid CoA

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

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

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