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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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Ethyl icosapentate

Registrant Name : Kemport Co., Ltd.

Registration Date : 2022-08-22

Registration Number : 20220822-211-J-1348

Manufacturer Name : Kemport Co., Ltd.

Manufacturer Address : Laboratory: 2nd floor, Research Building, 52, Goha-daero 719beongil, Mokpo-si, Jeolla...

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Icosapent Ethyl

About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...

Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-quality APIs on time & at scale, to the highest industry standards. It is dedicated to helping pharma companies make critical medicines safely to benefit patients. Leveraging our combined expertise & manufacturing capabilities across 9 industrial sites in the EU & India & an R&D facility in the USA, it offers CDMO services for small molecule APIs & biopharmaceuticals to innovators as well as APIs that address lifestyle-induced respiratory, inflammatory & liver diseases.
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Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

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Icosapent Ethyl

About the Company : DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering g...

DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering growth for businesses in Asia and beyond for over 155 years. DKSH operates in 36 markets, is listed on the SIX Swiss Exchange, employs 33,100 specialists, and generated net sales of CHF 11.1 billion in 2021. It is the leading global distributor of innovative pharma ingredients for pharmaceutical synthesis and formulation. It offers a range of products, ranging from animal care products to packaging materials, intermediates to nutraceuticals, and APIs to excipients.
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Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.

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Icosapent Ethyl

About the Company : Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers global customers cost-effective APIs with speed, supported by our well-trained staff. As the first company in Southeast...

Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers global customers cost-effective APIs with speed, supported by our well-trained staff. As the first company in Southeast Asia to receive FDA approval for synthetic and biotech APIs, CCSB has a proven track record of commercializing Statin, Immunosuppressant, Muscle Relaxant, and ACE Inhibitor APIs, all with complete DMF or COS. For years, CCSB has partnered with leading brand and generic drug companies to develop and produce APIs and advanced intermediates, focusing on specialty APIs crafted through a sophisticated fusion of fermentation and synthesis technologies in Taiwan.
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Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.

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Eicosapentaenoic Acid

About the Company : Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers global customers cost-effective APIs with speed, supported by our well-trained staff. As the first company in Southeast...

Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers global customers cost-effective APIs with speed, supported by our well-trained staff. As the first company in Southeast Asia to receive FDA approval for synthetic and biotech APIs, CCSB has a proven track record of commercializing Statin, Immunosuppressant, Muscle Relaxant, and ACE Inhibitor APIs, all with complete DMF or COS. For years, CCSB has partnered with leading brand and generic drug companies to develop and produce APIs and advanced intermediates, focusing on specialty APIs crafted through a sophisticated fusion of fermentation and synthesis technologies in Taiwan.
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05

BASF

Germany
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BASF

Germany
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EICOSAPENTAENOIC ACID ETHYL ESTER (EPA-E)

About the Company : We create chemistry for a sustainable future. In line with our corporate purpose, around 112,000 employees contribute to the success of our customers in nearly all sectors and alm...

We create chemistry for a sustainable future. In line with our corporate purpose, around 112,000 employees contribute to the success of our customers in nearly all sectors and almost every country in the world. Our broad portfolio ranges from chemicals, plastics, performance products and crop protection products to oil and gas. In 2015, BASF posted sales of €70 billion and income from operations before special items of approximately €6.7 billion. We combine economic success with environmental protection and social responsibility. Through research and innovation, we support our customers in nearly every industry.
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06

Royal DSM

Netherlands
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Royal DSM

Netherlands
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Icosapent Ethyl

About the Company : Royal DSM, founded in 1902, is a global, purpose-led health, nutrition, and bioscience company that specializes in human and animal health and nutrition solutions. Its primary goal...

Royal DSM, founded in 1902, is a global, purpose-led health, nutrition, and bioscience company that specializes in human and animal health and nutrition solutions. Its primary goal is to develop health and nutrition solutions that are scientifically sound. Royal DSM's products and solutions address some of the world's most pressing issues while also adding economic, environmental and societal value to all stakeholders. More than 2.5 billion people worldwide use the company's solutions. Royal DSM and its affiliated companies employ approximately 23,000 people worldwide and generate around €10 billion in net sales per year.
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07

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Icosapent Ethyl

About the Company : Guowei Pharmaceutical was established in 2005 and is headquartered in Chengdu High-tech Zone. Its subsidiaries include Chengdu Guowei Biopharmaceutical Co., Ltd., Sichuan Guowei Ph...

Guowei Pharmaceutical was established in 2005 and is headquartered in Chengdu High-tech Zone. Its subsidiaries include Chengdu Guowei Biopharmaceutical Co., Ltd., Sichuan Guowei Pharmaceutical Co., Ltd., and Shanghai Ocuen Biotechnology Co., Ltd. After years of development, Guowei Pharmaceutical has developed into a comprehensive pharmaceutical enterprise integrating R&D, production, and sales. Guowei Pharmaceutical's research and development and sales of products are mainly concentrated in the fields of cardiovascular and cerebrovascular, digestive system, anti-infection, and urinary system.
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08

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Icosapent Ethyl

About the Company : Zenfold Sustainable Technologies (ZST) is a specialty and fine chemicals company, established in 2021. Our advanced technological capabilities and state-of-the-art infrastructure a...

Zenfold Sustainable Technologies (ZST) is a specialty and fine chemicals company, established in 2021. Our advanced technological capabilities and state-of-the-art infrastructure allow us to provide the entire gamut of services involved in manufacturing and contract research — from process development to scaling up. We offer a wide range of APIs and intermediates to customers across industries. We differentiate ourselves in the market with our unique hybridized approach to manufacturing, built on our three core technological platforms: Synthetic Biology, Biotransformation, and Green Chemistry.
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09

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Icosapent Ethyl

About the Company : Zhejiang Medicine Co., Ltd. is a large-scale joint-stock comprehensive pharmaceutical enterprise which was set up in May 1997. Being approved in August 1999 by the China Securities...

Zhejiang Medicine Co., Ltd. is a large-scale joint-stock comprehensive pharmaceutical enterprise which was set up in May 1997. Being approved in August 1999 by the China Securities Regulatory Commission, the company issued 58 million A shares to the public, and in October of the same year the company shares were listed on the Shanghai Securities Exchange. Up to the third quarter of 2013, the registered capital has reached CNY 930,000,000, and the total assets have reached CNY 7,300,000,000. Zhejiang Medicine Co. Ltd. owns five subsidiaries including Xinchang Pharmaceutical Factory, Vitamin Factory, Zhejiang Changhai Biological Co. Ltd., Zhejiang Health Creation Bio-technology Co. Ltd., and Zhejiang Health Creation Pharmaceutical Co. Ltd., and two R&D units including Research Institute of Pharmaceutical Industry and Shanghai Health Creation Bio-Pharmaceutical R&D Center. The company has been rated as "National High-tech Enterprise" and "National Innovative Enterprise", which owns state-level enterprise technology center and also has established a postdoctoral research station. There are more than 5000 employees, more than 2000 of which are professional technicians accounting for more than 40%. At present, Zhejiang Medicine Co. Ltd. is specialized in the large-scale production of fat-soluble vitamins, quasi-vitamins, quinolone antibiotics, anti-drug-resistant antibiotics and other products. Its output of vitamin E is the largest domestically, and the 2nd largest globally; the output of Vancomycin hydrochloride accounts for more than 40% of the global production; it is the largest vendor of β-carotene and canthaxanthin domestically, and the 3rd globally; the output of Coenzyme Q10 accounts for 20% of the global production. Through earnestly implementing the development strategy of " innovation, competition, science and technology as well as talent thriving are all critical in the development of the company", Zhejiang Medicine Co., Ltd. tightly holds the main line of product development, highlights the structure adjustment and integration of various resources, strengthens the original technological innovation and competitive product technology innovation, does well on DMF file registration and FDA certification for some competitive varieties, actively promotes clean production and circular economy, builds perfect market network by taking globalization as standpoint, establishes good brand image , building up advanced enterprise culture, and strongly promotes the core competitiveness. Currently, Zhejiang Medicine Co., Ltd. has become a large-scale pharmaceutical company with advanced technology, strong capital and technical strength which has an influence in the global market.
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BD091924E97D00E0570 DTD. 19.09.2024)","address":"407\/408,SHARDA CHAMBERS,","city":"MUMBAI, MAHARASHTRA.","supplier":"AK BIOPHARM CO LTD","supplierCountry":"KOREA, REPUBLIC OF","foreign_port":"SEOUL - INCHEON INT\\'","customer":"BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LTD","customerCountry":"INDIA","quantity":"570.00","actualQuantity":"570","unit":"KGS","unitRateFc":"120","totalValueFC":"69052","currency":"USD","unitRateINR":"10152","date":"24-Sep-2024","totalValueINR":"5786640","totalValueInUsd":"69052","indian_port":"Bombay Air","hs_no":"29162090","bill_no":"5778026","productDescription":"API","marketType":"REGULATED MARKET","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,"},{"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":1740940200,"product":"ICOSAPENT ETHYL USP (CAS NO. 86227-47-6)","address":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"FLAVINE NORTH AMERICA INC","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"APL HEALTHCARE LTD","customerCountry":"INDIA","quantity":"203.25","actualQuantity":"203.25","unit":"KGS","unitRateFc":"500","totalValueFC":"102953.6","currency":"USD","unitRateINR":"43875","date":"03-Mar-2025","totalValueINR":"8917593.75","totalValueInUsd":"102953.6","indian_port":"SEZ\/Mahaboobnagar","hs_no":"29161990","bill_no":"8665168","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"61 SOUTH PARAMUS ROAD SUITE 565 PARAMUS NEW JERSEY SDNF UNITED STATES","customerAddress":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1749407400,"product":"ICOSAPENT ETHYL (INV NO. BD052125E97D00E0760) ICOSAPENT ETHYL (INV NO. BD052125E97D00E0760)","address":"407\/408,SHARDA CHAMBERS,","city":"MUMBAI, MAHARASHTRA.","supplier":"AK BIOPHARM CO LTD","supplierCountry":"KOREA, REPUBLIC OF","foreign_port":"SEOUL - INCHEON INT\\'","customer":"BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LTD","customerCountry":"INDIA","quantity":"760.00","actualQuantity":"760","unit":"KGS","unitRateFc":"109.6","totalValueFC":"84061.7","currency":"USD","unitRateINR":"9504","date":"09-Jun-2025","totalValueINR":"7223040","totalValueInUsd":"84061.7","indian_port":"Bombay Air","hs_no":"29162090","bill_no":"2542782","productDescription":"API","marketType":"REGULATED MARKET","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,"}]
27-Jan-2022
09-Jun-2025
KGS
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Drugs in Development

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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

01

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

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

Dr Reddy Company Banner

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

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

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

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

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

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

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

04

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

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

Strides Pharma Science

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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05

Amarin

Ireland
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AGGSpend
Not Confirmed

Amarin

Ireland
arrow
AGGSpend
Not Confirmed

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

blank

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

blank

06

Edding Pharm

China
arrow
AGGSpend
Not Confirmed

Edding Pharm

China
arrow
AGGSpend
Not Confirmed

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

blank

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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07

Amarin

Ireland
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AGGSpend
Not Confirmed

Amarin

Ireland
arrow
AGGSpend
Not Confirmed

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

blank

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

blank

08

Amarin

Ireland
arrow
AGGSpend
Not Confirmed

Amarin

Ireland
arrow
AGGSpend
Not Confirmed

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

blank

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

blank

09

Neopharm

Israel
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AGGSpend
Not Confirmed

Neopharm

Israel
arrow
AGGSpend
Not Confirmed

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

blank

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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10

Amarin

Ireland
arrow
AGGSpend
Not Confirmed

Amarin

Ireland
arrow
AGGSpend
Not Confirmed

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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FDF Dossiers

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  • 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

Regulatory Info : RX

Registration Country : USA

ICOSAPENT ETHYL

Brand Name : ICOSAPENT ETHYL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 1GM

Packaging :

Approval Date : 2020-08-07

Application Number : 209499

Regulatory Info : RX

Registration Country : USA

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02

  • 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

Regulatory Info : RX

Registration Country : USA

ICOSAPENT ETHYL

Brand Name : ICOSAPENT ETHYL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 500MG

Packaging :

Approval Date : 2023-03-08

Application Number : 209499

Regulatory Info : RX

Registration Country : USA

Dr Reddy Company Banner

03

AGGSpend
Not Confirmed
arrow
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AGGSpend
Not Confirmed

ICOSAPENT ETHYL

Brand Name : ICOSAPENT ETHYL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 1GM

Packaging :

Approval Date : 2024-02-16

Application Number : 216811

Regulatory Info : RX

Registration Country : USA

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04

Amarin

Ireland
AGGSpend
Not Confirmed
arrow

Amarin

Ireland
arrow
AGGSpend
Not Confirmed

ICOSAPENT ETHYL

Brand Name : VASCEPA

Dosage Form : CAPSULE;ORAL

Dosage Strength : 1GM

Packaging :

Approval Date : 2012-07-26

Application Number : 202057

Regulatory Info : RX

Registration Country : USA

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05

Amarin

Ireland
AGGSpend
Not Confirmed
arrow

Amarin

Ireland
arrow
AGGSpend
Not Confirmed

Ikosapentetyl

Brand Name : Vazkepa

Dosage Form : Kapsel, myk

Dosage Strength : 998 mg

Packaging : Boks 120item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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06

AGGSpend
Not Confirmed
arrow
arrow
AGGSpend
Not Confirmed

Eicosapentaenoic Acid

Brand Name :

Dosage Form : Capsule

Dosage Strength : 90MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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07

Hikma Pharmaceuticals

United Kingdom
AGGSpend
Not Confirmed
arrow

Hikma Pharmaceuticals

United Kingdom
arrow
AGGSpend
Not Confirmed

ICOSAPENT ETHYL

Brand Name : ICOSAPENT ETHYL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 1GM

Packaging :

Approval Date : 2020-05-21

Application Number : 209457

Regulatory Info : RX

Registration Country : USA

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08

Puracap

U.S.A
AGGSpend
Not Confirmed
arrow

Puracap

U.S.A
arrow
AGGSpend
Not Confirmed

ICOSAPENT ETHYL

Brand Name : ICOSAPENT ETHYL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 500MG

Packaging :

Approval Date : 2023-12-22

Application Number : 217919

Regulatory Info : RX

Registration Country : USA

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09

AGGSpend
Not Confirmed
arrow
arrow
AGGSpend
Not Confirmed

ICOSAPENT ETHYL

Brand Name : ICOSAPENT ETHYL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 500MG

Packaging :

Approval Date : 2020-09-11

Application Number : 209525

Regulatory Info : RX

Registration Country : USA

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10

AGGSpend
Not Confirmed
arrow
arrow
AGGSpend
Not Confirmed

ICOSAPENT ETHYL

Brand Name : ICOSAPENT ETHYL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 1GM

Packaging :

Approval Date : 2023-04-20

Application Number : 217656

Regulatory Info : RX

Registration Country : USA

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FDA Orange Book

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01

DR REDDYS

India
  • fda
  • EDQM
  • WHO-GMP

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

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Digital Content 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

Dr Reddy Company Banner

02

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

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

Dr Reddy Company Banner

03

HIKMA

United Kingdom
AGGSpend
Not Confirmed
arrow

HIKMA

United Kingdom
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Brand Name : ICOSAPENT ETHYL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 1GM

Approval Date : 2020-05-21

Application Number : 209457

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ICOSAPENT ETHYL

Brand Name : ICOSAPENT ETHYL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 500MG

Approval Date : 2023-03-08

Application Number : 209457

RX/OTC/DISCN : RX

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ICOSAPENT ETHYL

Brand Name : ICOSAPENT ETHYL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 500MG

Approval Date : 2023-12-22

Application Number : 217919

RX/OTC/DISCN : RX

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Brand Name : ICOSAPENT ETHYL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 1GM

Approval Date : 2023-12-22

Application Number : 217919

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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ICOSAPENT ETHYL

Brand Name : ICOSAPENT ETHYL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 500MG

Approval Date : 2020-09-11

Application Number : 209525

RX/OTC/DISCN : RX

RLD : No

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Brand Name : ICOSAPENT ETHYL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 1GM

Approval Date : 2020-09-11

Application Number : 209525

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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Brand Name : ICOSAPENT ETHYL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 1GM

Approval Date : 2023-04-20

Application Number : 217656

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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ICOSAPENT ETHYL

Brand Name : ICOSAPENT ETHYL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 500MG

Approval Date : 2023-09-22

Application Number : 217844

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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Brand Name : Vazkepa

Dosage Form : Kapsel, myk

Dosage Strength : 998 mg

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Registration Country : Norway

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Brand Name : Vazkepa

Dosage Form : Kapsel, myk

Dosage Strength : 998 mg

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Brand Name : VASCEPA

Dosage Form : CAPSULE

Dosage Strength : 1G

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Application Number : 2495244

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Registration Country : Canada

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icosapent ethyl

Brand Name : Vazkepa

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Packaging : 120

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Registration Country : Australia

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Virtual BoothNanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

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Brand Name : HDK® N20 PHARMA

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US Patent Number : 9198892

Drug Substance Claim :

Drug Product Claim :

Application Number : 202057

Patent Use Code : U-2706

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2027-09-25

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US Patent Number : 9693984

Drug Substance Claim :

Drug Product Claim :

Application Number : 202057

Patent Use Code : U-2697

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2033-06-28

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US Patent Number : 8426399

Drug Substance Claim :

Drug Product Claim :

Application Number : 202057

Patent Use Code : U-1287

Delist Requested :

Patent Use Description : METHOD OF REDUCING TG ...

Patent Expiration Date : 2030-02-09

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US Patent Number : 8710041

Drug Substance Claim :

Drug Product Claim :

Application Number : 202057

Patent Use Code : U-2690

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-06-15

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US Patent Number : 8415335

Drug Substance Claim :

Drug Product Claim :

Application Number : 202057

Patent Use Code : U-1287

Delist Requested :

Patent Use Description : METHOD OF REDUCING TG ...

Patent Expiration Date : 2030-02-09

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US Patent Number : 10842768

Drug Substance Claim :

Drug Product Claim :

Application Number : 202057

Patent Use Code : U-2688

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-06-15

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US Patent Number : 10792267

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Drug Product Claim :

Application Number : 202057

Patent Use Code : U-2961

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-04-29

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US Patent Number : 10668042

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Drug Product Claim :

Application Number : 202057

Patent Use Code : U-2841

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2033-06-28

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US Patent Number : 11213504

Drug Substance Claim :

Drug Product Claim :

Application Number : 202057

Patent Use Code : U-3292

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-04-29

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US Patent Number : 11298333

Drug Substance Claim :

Drug Product Claim :

Application Number : 202057

Patent Use Code : U-3358

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2033-06-28

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ABOUT THIS PAGE

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

Icosapent Ethyl manufacturers, exporters & distributors 1

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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 Ethyl Ester Manufacturers

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

Eicosapentaenoic Acid Ethyl Ester Suppliers

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

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

Eicosapentaenoic Acid Ethyl Ester USDMF

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

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

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

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

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

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

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

Eicosapentaenoic Acid Ethyl Ester GMP

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

Eicosapentaenoic Acid Ethyl Ester CoA

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

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