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01 1Axplora

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PharmaCompass

01

The Generic Rx Session
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAxplora- The partner of choice for complex APIs.

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

Axplora CB

02

The Generic Rx Session
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

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

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

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03

The Generic Rx Session
Not Confirmed

04

Ak And Mn Biofarm Co Ltd

South Korea

USDMF

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The Generic Rx Session
Not Confirmed

04

The Generic Rx Session
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 27998

Submission : 2014-02-10

Status : Active

Type : II

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05

The Generic Rx Session
Not Confirmed

06

The Generic Rx Session
Not Confirmed

07

The Generic Rx Session
Not Confirmed

07

The Generic Rx Session
Not Confirmed

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

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08

The Generic Rx Session
Not Confirmed

08

The Generic Rx Session
Not Confirmed

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

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09

The Generic Rx Session
Not Confirmed

10

The Generic Rx Session
Not Confirmed

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

Icosapent Ethyl manufacturers, exporters & distributors 1

66

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.

Icosapent Ethyl Manufacturers

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

Icosapent Ethyl Suppliers

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

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

Icosapent Ethyl USDMF

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

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

click here to find a list of Icosapent Ethyl 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.