Icosapent Ethyl | API DMFs | US Drug Master File (DMF) Details | Pharmacompass.com

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Icosapent Ethyl
USDMF

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

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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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xyz-pharma-m-2024-10-07

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With Fermion, start the journey of your innovative API.

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Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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xyz-pharma-m-2024-10-07

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Icosapent Ethyl

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

30 API Suppliers, 25 USDMF, 8 JDMF, 1 KDMF, 8 Listed Suppliers, $ API Reference Price

30 API Suppliers
25 USDMF
8 JDMF
1 KDMF
8 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

49 Drugs in Development

49 Drugs in Development

FINISHED DOSAGE FORMULATIONS

27 FDF Dossiers, 18 FDA Orange Book, 2 Europe, 1 Canada, 6 Listed Dossiers

27 FDF Dossiers
18 FDA Orange Book
2 Europe
1 Canada
6 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Evonik, 3 Rochem International Inc, 2 SPI Pharma, 9 DKSH, 1 Pharm-RX Chemical, 2 Faran Shimi Pharmaceutical, 3 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 6 Actylis, 1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 BASF, 1 Bioplus Life Sciences, 1 Finar, 7 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 2 Kerry, 3 Lonza Capsugel, 1 Nanjing Bold Chemical, 3 Pluviaendo, 1 Qualicaps, 14 Roquette, 6 Seppic, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Sigachi Industries, 1 Valens Pharmachem, 2 Zhejiang Huakang Pharmaceutical

1 Evonik
3 Rochem International Inc
2 SPI Pharma
9 DKSH
1 Pharm-RX Chemical
2 Faran Shimi Pharmaceutical
3 Gangwal Healthcare
5 Nanjing Well Pharmaceutical
1 Pfanstiehl
4 ACG Worldwide
6 Actylis
1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
2 BASF
1 Bioplus Life Sciences
1 Finar
7 Gangwal Chemicals
1 Ideal Cures Pvt Ltd
2 Kerry
3 Lonza Capsugel
1 Nanjing Bold Chemical
3 Pluviaendo
1 Qualicaps
14 Roquette
6 Seppic
1 Shijiazhuang Huaxu Pharmaceutical
1 Sigachi Industries
1 Valens Pharmachem
2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

14 Parenteral, 14 Film Formers & Plasticizers, 14 Solubilizers, 13 Fillers, Diluents & Binders, 12 Taste Masking, 12 Coating Systems & Additives, 11 Thickeners and Stabilizers, 9 Topical, 8 Empty Capsules, 7 Emulsifying Agents, 5 Chewable & Orodispersible Aids, 4 Direct Compression, 4 Controlled & Modified Release, 3 Co-Processed Excipients, 3 Disintegrants & Superdisintegrants, 3 Coloring Agents, 2 API Stability Enhancers, 2 Surfactant & Foaming Agents, 2 Lubricants & Glidants, 1 Soft Gelatin, 1 Rheology Modifiers

14 Parenteral
14 Film Formers & Plasticizers
14 Solubilizers
13 Fillers, Diluents & Binders
12 Taste Masking
12 Coating Systems & Additives
11 Thickeners and Stabilizers
9 Topical
8 Empty Capsules
7 Emulsifying Agents
5 Chewable & Orodispersible Aids
4 Direct Compression
4 Controlled & Modified Release
3 Co-Processed Excipients
3 Disintegrants & Superdisintegrants
3 Coloring Agents
2 API Stability Enhancers
2 Surfactant & Foaming Agents
2 Lubricants & Glidants
1 Soft Gelatin
1 Rheology Modifiers

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 155 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
155 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 2 Finished Drug Prices

1 US Medicaid Prescriptions
2 Finished Drug Prices

MARKET PLACE

21 APIs

21 APIs

PATENTS & EXCLUSIVITIES

129 US Patents

129 US Patents

REF. STANDARDS & IMPURITIES

1 EDQM, 1 USP, 2 JP, 2 Others

1 EDQM
1 USP
2 JP
2 Others

$ API Ref.Price (USD/KG) : 220 Xls

Filters

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25 All

01 1Axplora

02 1Chunghwa Chemical Synthesis & Biotech

03 1AK & MN BioFarm

04 2AK AND MN BIOFARM CO LTD

05 1BASF

06 2Bizen Chemical Co. - Ltd

07 1Catalent Pharma Solutions

08 2Chemport Inc

09 1Huatai Biopharm Inc

10 2K.D. Pharma Bexbach GmbH

11 2KinOmega Biopharm Inc.

12 2NIPPON SUISAN KAISHA LTD

13 1NISSHIN PHARMA INC

14 2Shandong Xinhua Pharmaceutical

15 1Sichuan Gowell Pharmaceutical

16 1Skuny Bioscience Co.,Ltd

17 2Zhejiang Medicine Co Ltd

filter Subject Reset all filters

25 All

01 1AK & MN BIOFARM ICOSAPENTATE

02 1AMR101 1G CAPSULES

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

04 1EICOSAPENTAENOIC ACID ETHYL ESTER

05 1EICOSAPENTAENOIC ACID ETHYL ESTER (EPA-E)

06 1EICOSAPENTAENOIC ACID, 90% ETHYL ESTER

07 1EPA 550/DHA 200 FFA

08 1EPA ETHYL ESTER

09 1EPA ETHYL ESTER 70

10 1EPA-E DRUG SUBSTANCE

11 1EPA-E NISSUI KASHIMA

12 1EPA-E NISSUI TSUKUBA

13 1EPA960EE (ICOSAPENT ETHYL)

14 2ETHYL ICOSAPENTATE

15 2ETHYL ICOSAPENTATE 70

16 1ETHYL ICOSAPENTATE 98

17 6ICOSAPENT ETHYL

18 1ICOSAPENTOSAN EQ

filter Country Reset all filters

25 All

01 9China

02 4Germany

03 5Japan

04 3South Korea

05 1Taiwan

06 1U.S.A

07 2United Kingdom

filter Status Reset all filters

25 All

01 22Active

02 3Inactive

filter GDUFA DMF Review Reset all filters

25 All

01 10Complete

02 15Blank

List of Suppliers

Product Main Page

01

Finorga Sas

Antibody Engineering

Not Confirmed

Axplora- The partner of choice for complex APIs.

Contact Supplier

Contact Supplier

Digital Content

Icosapent Ethyl

GDUFA

DMF Review : Complete

Rev. Date : 2023-06-07

Pay. Date : 2023-06-05

DMF Number : 27182

Submission : 2013-05-23

Status : Active

Type : II

Product Web Link

Digital Content

02

Chunghwa Chemical Synthesis And Biot...

Antibody Engineering

Not Confirmed

Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.

Contact Supplier

Contact Supplier

Digital Content

Ethyl Icosapentate

GDUFA

DMF Review : Complete

Rev. Date : 2013-04-01

Pay. Date : 2012-11-20

DMF Number : 26271

Submission : 2012-08-01

Status : Active

Type : II

CCSB Company Banner

Product Web Link

Digital Content

03

Ak Biopharm Co Ltd

USDMF

Antibody Engineering

Not Confirmed

03

Ak Biopharm Co Ltd

Antibody Engineering

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Epa Ethyl Ester 70

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 26946

Submission : 2013-03-04

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Ak And Mn Biofarm Co Ltd

South Korea

USDMF

Antibody Engineering

Not Confirmed

04

Ak And Mn Biofarm Co Ltd

South Korea

Antibody Engineering

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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South Korea

Digital Content

Ak & Mn Biofarm Icosapentate

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 27998

Submission : 2014-02-10

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Basf As

USDMF

Antibody Engineering

Not Confirmed

05

Basf As

Antibody Engineering

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Eicosapentaenoic Acid Ethyl Ester (epa-e)

GDUFA

DMF Review : Complete

Rev. Date : 2020-11-02

Pay. Date : 2020-10-20

DMF Number : 23911

Submission : 2010-07-07

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Bizen Chemical Co Ltd

USDMF

Antibody Engineering

Not Confirmed

06

Bizen Chemical Co Ltd

Antibody Engineering

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Bizen Epa-e (icosapent Ethyl) Drug Substance

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 30007

Submission : 2015-11-04

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Kd Pharma Bexbach Gmbh

USDMF

Antibody Engineering

Not Confirmed

07

Kd Pharma Bexbach Gmbh

Antibody Engineering

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Post an Enquiry

Digital Content

Epa 550/dha 200 Ffa

GDUFA

DMF Review : Complete

Rev. Date : 2015-02-20

Pay. Date : 2014-04-09

DMF Number : 28140

Submission : 2014-03-31

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Kd Pharma Bexbach Gmbh

USDMF

Antibody Engineering

Not Confirmed

08

Kd Pharma Bexbach Gmbh

Antibody Engineering

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Eicosapentaenoic Acid Ethyl Ester

GDUFA

DMF Review : Complete

Rev. Date : 2013-08-21

Pay. Date : 2013-02-27

DMF Number : 26892

Submission : 2013-02-26

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Nissui Corporation

USDMF

Antibody Engineering

Not Confirmed

09

Nissui Corporation

Antibody Engineering

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Post an Enquiry

Digital Content

Epa-e Nissui Tsukuba

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 22474

Submission : 2009-01-23

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Nisshin Pharma Inc

USDMF

Antibody Engineering

Not Confirmed

10

Nisshin Pharma Inc

Antibody Engineering

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Epa-e Drug Substance

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 15062

Submission : 2000-09-29

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

1
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Icosapent Ethyl Manufacturers | Traders | Suppliers

Icosapent Ethyl Manufacturers, Traders, Suppliers 1

15

We have 17 companies offering Icosapent Ethyl

Get in contact with the supplier of your choice:

Axplora
Chunghwa Chemical Synthesis & Biotech
AK & MN BioFarm
AK AND MN BIOFARM CO LTD
BASF
Bizen Chemical Co. - Ltd
Catalent Pharma Solutions
Chemport Inc
Huatai Biopharm Inc
K.D. Pharma Bexbach GmbH
KinOmega Biopharm Inc.
NIPPON SUISAN KAISHA LTD
NISSHIN PHARMA INC
Shandong Xinhua Pharmaceutical
Sichuan Gowell Pharmaceutical
Skuny Bioscience Co.,Ltd
Zhejiang Medicine Co Ltd

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