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    List of Drug Master Files (KDMF) for Icosapent Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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    Icosapent

    APIs // Active Pharmaceutical Ingredients

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    01 Chemport Co., Ltd. (1)

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    01 Chemport Co., Ltd. (1)

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    01 Ethyl eicosapentate (1)

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    01 United Kingdom (1)

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    Chemport Inc

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      Ethyl eicosapentate

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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

      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 Manufacturers

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

      Icosapent Suppliers

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

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

      Icosapent KDMF

      In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

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

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

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

      Icosapent Manufacturers | Traders | Suppliers

      Icosapent Manufacturers, Traders, Suppliers 1
      31

      We have 1 companies offering Icosapent

      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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