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List of Korea Drug Master Files (KDMF) for Eicosapentaenoic Acid Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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Chemport Co., Ltd.
2022-08-22
20220822-211-J-1348
Chemport Co., Ltd.
South Korea
30-51 Dongsu Agro-Gongdan...
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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 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 Drug Master File in Korea (Eicosapentaenoic Acid KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Eicosapentaenoic Acid. The MFDS reviews the Eicosapentaenoic Acid KDMF as part of the drug registration process and uses the information provided in the Eicosapentaenoic Acid KDMF to evaluate the safety and efficacy of the drug.

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

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

Eicosapentaenoic Acid Manufacturers | Traders | Suppliers

Eicosapentaenoic Acid Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Eicosapentaenoic Acid

Get in contact with the supplier of your choice:

  1. Chemport Inc
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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