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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
    Icosapent Ethyl
    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 Weight 302.5 g/mol
    Molecular Formula C20H30O2
    XLogP35.6
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count2
    Rotatable Bond Count13
    Exact Mass302.224580195 g/mol
    Monoisotopic Mass302.224580195 g/mol
    Topological Polar Surface Area37.3 Ų
    Heavy Atom Count22
    Formal Charge0
    Complexity398
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count5
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    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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    Status : Active

    Type : II

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    KinOmega Biopharm Inc.

    China

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    KinOmega Biopharm Inc.

    China

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    DMF Number : 39040

    Submission : 2023-10-25

    Status : Active

    Type : II

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    AK AND MN BIOFARM CO LTD

    South Korea

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    AK AND MN BIOFARM CO LTD

    South Korea

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    DMF Number : 27998

    Submission : 2014-02-10

    Status : Active

    Type : II

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    API Reference Price

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    [{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1643221800,"product":"ICOSAPENT ETHYL EICOSAPENTAENOIC ACID ETHYL ESTER (MAXOMEGATM EPA 96EE)(100 KG\/10 KG PER BOTTLE. 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BD062923E97D00E0760 DTD. 29.06.2023)","address":"407\/408 SHARDA CHAMBERS,NEW MARINE LINES","city":"MUMBAI,MAHARASHTRA","supplier":"AK MN BIOFARM COLTD","supplierCountry":"KOREA, REPUBLIC OF","foreign_port":"NA","customer":"BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LTD","customerCountry":"INDIA","quantity":"760.00","actualQuantity":"760","unit":"KGS","unitRateFc":"154","totalValueFC":"118550.1","currency":"USD","unitRateINR":"12820.7","date":"14-Jul-2023","totalValueINR":"9743580.175","totalValueInUsd":"118550.1","indian_port":"BOMBAY AIR","hs_no":"29162090","bill_no":"0","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":"2023","qtr":"Q3","strtotime":1696012200,"product":"EICOSAPENTAENOIC ACID","address":"8-3-166\/7\/1, HETERO HOUSE,","city":"HYDERABAD, AP.","supplier":"UNDISCLOSED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"HONOUR LAB LTD","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"223","totalValueFC":"5645","currency":"USD","unitRateINR":"18743.2","date":"30-Sep-2023","totalValueINR":"468579","totalValueInUsd":"5645","indian_port":"Madras Air","hs_no":"29161290","bill_no":"8084558","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"N\/A","customerAddress":"8-3-166\/7\/1, HETERO HOUSE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1708453800,"product":"ETHYL ICOSAPENTATE OMEGA 3 - ORGANIC CHEMICAL","address":"NO S 26 BOMMASANDRA INDUSTRIAL ARE","city":"BANGALORE,KARNATAKA","supplier":"FINORGA SAS","supplierCountry":"FRANCE","foreign_port":"PARIS - CHARLES DE G","customer":"ALTHERA LABORATORIES INDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"428","totalValueFC":"4676","currency":"EURO","unitRateINR":"38798.2","date":"21-Feb-2024","totalValueINR":"387982","totalValueInUsd":"4676","indian_port":"Bangalore Air","hs_no":"29161990","bill_no":"2240597","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"PARIS - CHARLES DE G","supplierAddress":"AVENUE DU LAC,F-64150, MOURENX,FRANCESDNF France","customerAddress":"NO S 26 BOMMASANDRA INDUSTRIAL ARE"},{"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 CO LTD","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"AUROBINDO PHARMA LTD","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":"2025","qtr":"Q1","strtotime":1737743400,"product":"EICOSAPENTAENOIC ACID EICOSAPENTAENOIC ACID","address":"8-3-166\/7\/1, HETERO HOUSE,","city":"HYDERABAD, AP.","supplier":"JIANGSU GUOTAI GUOMIAN TRADING CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"HONOUR LAB LTD","customerCountry":"INDIA","quantity":"30.00","actualQuantity":"30","unit":"KGS","unitRateFc":"235","totalValueFC":"7121.2","currency":"USD","unitRateINR":"20468.5","date":"25-Jan-2025","totalValueINR":"614055","totalValueInUsd":"7121.2","indian_port":"Madras Air","hs_no":"29161990","bill_no":"7989915","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"19-21\/F GUOTAI BLDG.,RENMIN ROAD, ZHANGJIAGANG,JIANGSU, CHINA","customerAddress":"8-3-166\/7\/1, HETERO HOUSE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738261800,"product":"ETHYL EICOSAPENTAENOATE ETHYL","address":"2ND FLOOR, DAARUL AWKAF, NO.6","city":"BANGALORE","supplier":"NISSHIN PHARMA INC","supplierCountry":"JAPAN","foreign_port":"TOKYO - NARITA","customer":"PHARMALEAF INDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"365.10","actualQuantity":"365.1","unit":"KGS","unitRateFc":"111.4","totalValueFC":"41072.5","currency":"USD","unitRateINR":"9700.5","date":"31-Jan-2025","totalValueINR":"3541646.64","totalValueInUsd":"41072.5","indian_port":"Delhi Air","hs_no":"29163990","bill_no":"8109039","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TOKYO - NARITA","supplierAddress":"25, Kanda-Nishiki-cho 1-chome, Chiyoda-ku, Tokyo, 101-8441 Japan","customerAddress":"2ND FLOOR, DAARUL AWKAF, NO.6"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741631400,"product":"ICOSAPENT ETHYL USP","address":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"FLAVINE NORTH AMERICA INC","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"APL HEALTHCARE LTD","customerCountry":"INDIA","quantity":"1710.00","actualQuantity":"1710","unit":"KGS","unitRateFc":"221.9","totalValueFC":"384708.9","currency":"USD","unitRateINR":"19486.9","date":"11-Mar-2025","totalValueINR":"33322556","totalValueInUsd":"384708.9","indian_port":"SEZ\/Mahaboobnagar","hs_no":"29420090","bill_no":"8819590","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"61 SOUTH PARAMUS ROAD SUITE 565 PARAMUS NEW JERSEY SDNF UNITED STATES","customerAddress":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,"}]
    27-Jan-2022
    11-Mar-2025
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    Drugs in Development

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

    Dr Reddy's Laboratories launches Icosapent Ethyl Capsules in US

    Details:

    Dr Reddy's Laboratories announced the launch of Icosapent Ethyl Capsules, used to reduce triglyceride (TG) levels in adult patients, in the US market. Dr Reddy's Icosapent Ethyl is available in 1 gram capsules in bottle count size of 120's count.


    Lead Product(s): Icosapent Ethyl

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 22, 2021

    Dr Reddy Company Banner

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    Dr. Reddy's Laboratories

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

    Lead Product(s) : Icosapent Ethyl

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Dr Reddy's Laboratories launches Icosapent Ethyl Capsules in US

    Details : Dr Reddy's Laboratories announced the launch of Icosapent Ethyl Capsules, used to reduce triglyceride (TG) levels in adult patients, in the US market. Dr Reddy's Icosapent Ethyl is available in 1 gram capsules in bottle count size of 120's count.

    Product Name : Undisclosed

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    June 22, 2021

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    Stock Recap
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    Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

    Strides Receives USFDA Approval for Icosapent Ethyl Capsules

    Details:

    Icosapent ethyl capsules is an ethyl ester of eicosapentaenoic acid (EPA), which is indicated for the treatment of to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina in adult patients with elevated triglyceride.


    Lead Product(s): Icosapent Ethyl

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Vascepa-Generic

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 10, 2023

    Strides Pharma Science

    02

    Strides Pharma Science

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    Booth # 9.1F6 & 9.1G41
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    Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

    Lead Product(s) : Icosapent Ethyl

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Strides Receives USFDA Approval for Icosapent Ethyl Capsules

    Details : Icosapent ethyl capsules is an ethyl ester of eicosapentaenoic acid (EPA), which is indicated for the treatment of to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina in adult patients with elevated trigly...

    Product Name : Vascepa-Generic

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    March 10, 2023

    Strides Pharma Science

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    Strides Launches Icosapent Ethyl Acid Soft Gel Capsules in Partnership with Amneal

    Details:

    Vascepa-Generic (icosapent ethyl) is an ethyl ester of eicosapentaenoic acid (EPA) which is indicated to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina.


    Lead Product(s): Icosapent Ethyl

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Vascepa-Generic

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Amneal Pharmaceuticals

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable February 12, 2023

    Strides Pharma Science

    03

    Strides Pharma Science

    India
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    CPhI WW Frankfurt
    Booth # 9.1F6 & 9.1G41
    • fda
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    Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

    Lead Product(s) : Icosapent Ethyl

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Amneal Pharmaceuticals

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Strides Launches Icosapent Ethyl Acid Soft Gel Capsules in Partnership with Amneal

    Details : Vascepa-Generic (icosapent ethyl) is an ethyl ester of eicosapentaenoic acid (EPA) which is indicated to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina.

    Product Name : Vascepa-Generic

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    February 12, 2023

    Strides Pharma Science

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    Amneal Expands Portfolio with Addition of Icosapent Ethyl Acid Soft Gel Capsules

    Details:

    Under the agreement, Amneal in-licensed Icosapent ethyl acid soft gel capsules, a product referencing Vascepa and an ethyl ester of eicosapentaenoic acid that is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.


    Lead Product(s): Icosapent Ethyl

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Vascepa-Generic

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Amneal Pharmaceuticals

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement January 12, 2023

    Strides Pharma Science

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    Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

    Lead Product(s) : Icosapent Ethyl

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Amneal Pharmaceuticals

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

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    Amneal Expands Portfolio with Addition of Icosapent Ethyl Acid Soft Gel Capsules

    Details : Under the agreement, Amneal in-licensed Icosapent ethyl acid soft gel capsules, a product referencing Vascepa and an ethyl ester of eicosapentaenoic acid that is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe ...

    Product Name : Vascepa-Generic

    Product Type : Other Small Molecule

    Upfront Cash : Undisclosed

    January 12, 2023

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    Amarin Announces Exclusive License and Supply Agreement with Recordati

    Details:

    Under the licensing agreement, Recordati will be responsible for commercialization of Vazkepa (Icosapent Ethyl) in Europe. It is being indicated to reduce the risk of myocardial infarction, stroke.


    Lead Product(s): Icosapent Ethyl

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Vascepa

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Recordati

    Deal Size: $175.0 million Upfront Cash: $25.0 million

    Deal Type: Licensing Agreement June 24, 2025

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    Lead Product(s) : Icosapent Ethyl

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Recordati

    Deal Size : $175.0 million

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Amarin Announces Exclusive License and Supply Agreement with Recordati

    Details : Under the licensing agreement, Recordati will be responsible for commercialization of Vazkepa (Icosapent Ethyl) in Europe. It is being indicated to reduce the risk of myocardial infarction, stroke.

    Product Name : Vascepa

    Product Type : Other Small Molecule

    Upfront Cash : $25.0 million

    June 24, 2025

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    Amarin Partner EddingPharm Gets Approval for VASCEPA® in China for CVRR

    Details:

    Vascepa (icosapent ethyl) is an ethyl ester of eicosapentaenoic acid (EPA) which is indicated to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina.


    Lead Product(s): Icosapent Ethyl

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Vascepa

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 07, 2024

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    Edding Pharm

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    Lead Product(s) : Icosapent Ethyl

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Amarin Partner EddingPharm Gets Approval for VASCEPA® in China for CVRR

    Details : Vascepa (icosapent ethyl) is an ethyl ester of eicosapentaenoic acid (EPA) which is indicated to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina.

    Product Name : Vascepa

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    August 07, 2024

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    Amarin Receives National Reimbursement for VAZKEPA® in Greece and Signs Marketing Deal

    Details:

    Under the terms of the agreement, Vianex will be the sole and exclusive distributor of Vazkepa (icosapent ethyl). it is an approved product indicated for the treatment of cardiovascular diseases.


    Lead Product(s): Icosapent Ethyl

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Vazkepa

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Vianex S.A

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement May 28, 2024

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    Lead Product(s) : Icosapent Ethyl

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Vianex S.A

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Amarin Receives National Reimbursement for VAZKEPA® in Greece and Signs Marketing Deal

    Details : Under the terms of the agreement, Vianex will be the sole and exclusive distributor of Vazkepa (icosapent ethyl). it is an approved product indicated for the treatment of cardiovascular diseases.

    Product Name : Vazkepa

    Product Type : Other Small Molecule

    Upfront Cash : Undisclosed

    May 28, 2024

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    Amarin Provides Pricing & Reimbursement Updates for VAZKEPA (icosapent ethyl) in The Netherlands and Italy

    Details:

    Vazkepa (icosapent ethyl) is an ethyl ester of eicosapentaenoic acid that reduces synthesis and enhances clearance of triglycerides that is used to treat patients with severe hypertriglyceridemia.


    Lead Product(s): Icosapent Ethyl

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Vazkepa

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 08, 2023

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    Lead Product(s) : Icosapent Ethyl

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Amarin Provides Pricing & Reimbursement Updates for VAZKEPA (icosapent ethyl) in The Netherlands a...

    Details : Vazkepa (icosapent ethyl) is an ethyl ester of eicosapentaenoic acid that reduces synthesis and enhances clearance of triglycerides that is used to treat patients with severe hypertriglyceridemia.

    Product Name : Vazkepa

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    September 08, 2023

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    Amarin and Neopharm Announce Exclusive Commercialization Agreement for VAZKEPA® (Icosapent Ethyl) in Israel

    Details:

    Under the agreement, Amarin has appointed Neopharm as its sole and exclusive distributor of Vazkepa (icosapent ethyl) approved to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides in Israel.


    Lead Product(s): Icosapent Ethyl

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Vazkepa

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Amarin

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement August 08, 2023

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    Lead Product(s) : Icosapent Ethyl

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Amarin

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Amarin and Neopharm Announce Exclusive Commercialization Agreement for VAZKEPA® (Icosapent Ethyl)...

    Details : Under the agreement, Amarin has appointed Neopharm as its sole and exclusive distributor of Vazkepa (icosapent ethyl) approved to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglyce...

    Product Name : Vazkepa

    Product Type : Other Small Molecule

    Upfront Cash : Undisclosed

    August 08, 2023

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    Amarin and Lotus Pharmaceuticals Announce Exclusive Partnership Agreement to Commercialize Vazkepa® (Icosapent Ethyl) in Southeast Asia and South Korea

    Details:

    The partnership aims to distribute and commercialize Vazkepa (icosapent ethyl), approved and commercialized in a number of global markets, including the U.S. and European markets, across 10 countries, including nine in Southeast Asia and South Korea.


    Lead Product(s): Icosapent Ethyl

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Vazkepa

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Lotus Pharmaceutical Industries

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Partnership July 31, 2023

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    Lead Product(s) : Icosapent Ethyl

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Lotus Pharmaceutical Industries

    Deal Size : Undisclosed

    Deal Type : Partnership

    DEALS_DEV arrow-down

    Amarin and Lotus Pharmaceuticals Announce Exclusive Partnership Agreement to Commercialize Vazkepa...

    Details : The partnership aims to distribute and commercialize Vazkepa (icosapent ethyl), approved and commercialized in a number of global markets, including the U.S. and European markets, across 10 countries, including nine in Southeast Asia and South Korea.

    Product Name : Vazkepa

    Product Type : Other Small Molecule

    Upfront Cash : Undisclosed

    July 31, 2023

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    ABOUT THIS PAGE

    Looking for 10417-94-4 / Icosapent Ethyl API manufacturers, exporters & distributors?

    Icosapent Ethyl manufacturers, exporters & distributors 1

    93

    PharmaCompass offers a list of Icosapent Ethyl API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Icosapent Ethyl manufacturer or Icosapent Ethyl supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Icosapent Ethyl manufacturer or Icosapent Ethyl supplier.

    PharmaCompass also assists you with knowing the Icosapent Ethyl API Price utilized in the formulation of products. Icosapent Ethyl API Price is not always fixed or binding as the Icosapent Ethyl Price is obtained through a variety of data sources. The Icosapent Ethyl Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Icosapent Ethyl

    Synonyms

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

    Cas Number

    10417-94-4

    Unique Ingredient Identifier (UNII)

    AAN7QOV9EA

    About Icosapent Ethyl

    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.

    Eicosapentaenoic acid (c20:5 n3) Manufacturers

    A Eicosapentaenoic acid (c20:5 n3) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eicosapentaenoic acid (c20:5 n3), including repackagers and relabelers. The FDA regulates Eicosapentaenoic acid (c20:5 n3) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eicosapentaenoic acid (c20:5 n3) 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 (c20:5 n3) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Eicosapentaenoic acid (c20:5 n3) Suppliers

    A Eicosapentaenoic acid (c20:5 n3) supplier is an individual or a company that provides Eicosapentaenoic acid (c20:5 n3) active pharmaceutical ingredient (API) or Eicosapentaenoic acid (c20:5 n3) finished formulations upon request. The Eicosapentaenoic acid (c20:5 n3) suppliers may include Eicosapentaenoic acid (c20:5 n3) API manufacturers, exporters, distributors and traders.

    click here to find a list of Eicosapentaenoic acid (c20:5 n3) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Eicosapentaenoic acid (c20:5 n3) USDMF

    A Eicosapentaenoic acid (c20:5 n3) DMF (Drug Master File) is a document detailing the whole manufacturing process of Eicosapentaenoic acid (c20:5 n3) active pharmaceutical ingredient (API) in detail. Different forms of Eicosapentaenoic acid (c20:5 n3) DMFs exist exist since differing nations have different regulations, such as Eicosapentaenoic acid (c20:5 n3) USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Eicosapentaenoic acid (c20:5 n3) DMF submitted to regulatory agencies in the US is known as a USDMF. Eicosapentaenoic acid (c20:5 n3) USDMF includes data on Eicosapentaenoic acid (c20:5 n3)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eicosapentaenoic acid (c20:5 n3) USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Eicosapentaenoic acid (c20:5 n3) suppliers with USDMF on PharmaCompass.

    Eicosapentaenoic acid (c20:5 n3) 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 (c20:5 n3) Drug Master File in Japan (Eicosapentaenoic acid (c20:5 n3) JDMF) empowers Eicosapentaenoic acid (c20:5 n3) 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 (c20:5 n3) JDMF during the approval evaluation for pharmaceutical products. At the time of Eicosapentaenoic acid (c20:5 n3) 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 (c20:5 n3) suppliers with JDMF on PharmaCompass.

    Eicosapentaenoic acid (c20:5 n3) 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 (c20:5 n3) Drug Master File in Korea (Eicosapentaenoic acid (c20:5 n3) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Eicosapentaenoic acid (c20:5 n3). The MFDS reviews the Eicosapentaenoic acid (c20:5 n3) KDMF as part of the drug registration process and uses the information provided in the Eicosapentaenoic acid (c20:5 n3) KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Eicosapentaenoic acid (c20:5 n3) 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 (c20:5 n3) API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Eicosapentaenoic acid (c20:5 n3) suppliers with KDMF on PharmaCompass.

    Eicosapentaenoic acid (c20:5 n3) GMP

    Eicosapentaenoic acid (c20:5 n3) 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 (c20:5 n3) 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 (c20:5 n3) GMP manufacturer or Eicosapentaenoic acid (c20:5 n3) GMP API supplier for your needs.

    Eicosapentaenoic acid (c20:5 n3) CoA

    A Eicosapentaenoic acid (c20:5 n3) CoA (Certificate of Analysis) is a formal document that attests to Eicosapentaenoic acid (c20:5 n3)'s compliance with Eicosapentaenoic acid (c20:5 n3) specifications and serves as a tool for batch-level quality control.

    Eicosapentaenoic acid (c20:5 n3) CoA mostly includes findings from lab analyses of a specific batch. For each Eicosapentaenoic acid (c20:5 n3) 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 (c20:5 n3) may be tested according to a variety of international standards, such as European Pharmacopoeia (Eicosapentaenoic acid (c20:5 n3) EP), Eicosapentaenoic acid (c20:5 n3) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Eicosapentaenoic acid (c20:5 n3) 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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