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List of Drug Master Files (DMF) of Eicosapentaenoic Acid Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Axplora (1)

02 Royal DSM (1)

03 AK & MN BioFarm (1)

04 AK AND MN BIOFARM CO LTD (2)

05 BASF (1)

06 Bizen Chemical Co. - Ltd (5)

07 Catalent Pharma Solutions (1)

08 Chemport Inc (2)

09 Chunghwa Chemical Synthesis & Biotech (1)

10 Huatai Biopharm Inc (1)

11 K.D. Pharma Bexbach GmbH (2)

12 KinOmega Biopharm Inc. (2)

13 NIPPON SUISAN KAISHA LTD (2)

14 NISSHIN PHARMA INC (1)

15 Shandong Xinhua Pharmaceutical (2)

16 Sichuan Gowell Pharmaceutical (1)

17 Skuny Bioscience Co.,Ltd (1)

18 Zhejiang Medicine Co Ltd (1)

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01 AK & MN BIOFARM ICOSAPENTATE (1)

02 AMR101 1G CAPSULES (1)

03 BIZEN EPA-70E (ICOSAPENT ETHYL) DRUG SUBSTANCE INTERMEDIATE (1)

04 BIZEN EPA-E (ICOSAPENT ETHYL) DRUG SUBSTANCE (1)

05 BIZEN EPA-EC (ICOSAPENT ETHYL) INTERMEDIATE (1)

06 BIZEN EPA-EC (ICOSAPENT ETHYL) DRUG SUBSTANCE INTERMEDIATE (1)

07 EICOSAPENTAENOIC ACID ETHYL ESTER (1)

08 EICOSAPENTAENOIC ACID ETHYL ESTER (EPA-E) (1)

09 EICOSAPENTAENOIC ACID, 90% ETHYL ESTER (1)

10 EPA 550/DHA 200 FFA (1)

11 EPA ETHYL ESTER (1)

12 EPA ETHYL ESTER 70 (1)

13 EPA-E DRUG SUBSTANCE (1)

14 EPA-E NISSUI KASHIMA (1)

15 EPA-E NISSUI TSUKUBA (1)

16 EPA960EE (ICOSAPENT ETHYL) (1)

17 ETHYL ICOSAPENTATE (1)

18 ETHYL ICOSAPENTATE 70 (2)

19 ETHYL ICOSAPENTATE 98 (1)

20 HIGH EPA INTERMEDIATE FISH OIL (1)

21 ICOSAPENT ETHYL (6)

22 ICOSAPENTOSAN EQ (1)

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01 China (8)

02 Germany (4)

03 Japan (8)

04 Netherlands (1)

05 South Korea (3)

06 Taiwan (1)

07 U.S.A (1)

08 United Kingdom (2)

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01 Active (25)

02 Inactive (3)

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01 Complete (9)

02 Blank (19)

27182
Active
2013-05-23
Complete
2023-06-07
2023-06-05
II
Axplora CB

RDD 2024

Not Confirmed

envelop Contact Supplier
URL Supplier Web Content
25420
Active
2011-11-22
N/A
II
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26946
Active
2013-03-04
N/A
II
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Flag South Korea
Digital Content Digital Content
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27998
Active
2014-02-10
N/A
II
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23911
Active
2010-07-07
Complete
2020-11-02
2020-10-20
II
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26271
Active
2012-08-01
Complete
2013-04-01
2012-11-20
II
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26892
Active
2013-02-26
Complete
2013-08-21
2013-02-27
II
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28140
Active
2014-03-31
Complete
2015-02-20
2014-04-09
II
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22474
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2009-01-23
N/A
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15062
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2000-09-29
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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 Manufacturers

A Eicosapentaenoic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eicosapentaenoic Acid, including repackagers and relabelers. The FDA regulates Eicosapentaenoic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eicosapentaenoic Acid API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

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

Eicosapentaenoic Acid Suppliers

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

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

Eicosapentaenoic Acid USDMF

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

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

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

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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