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List of Drug Master Files (JDMF) for Eicosapentaenoic Acid Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 AK BIOPHARM CO. , LTD. (1)

02 BASF Pharma (Callanish) Ltd. (1)

03 Bizen Kasei Co., Ltd. (1)

04 Chemport Inc. (1)

05 Huatai Pharma Inc. (1)

06 K. D. Pharma Bexbach GmbH (2)

07 Shandong Xinhua Pharmaceutical Co. , Ltd. (1)

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01 Aye Kay & M N. bio farm Ikosapenteto (raw material) (for export) (1)

02 ETHYL ICOSAPENTATE (1)

03 Eicosapentaenoic San EQ (1)

04 Eicosapentaenoic acid ethyl (2)

05 Ethyl icosapentaenoate (2)

06 Makusomega EPA97EE (1)

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01 China (2)

02 Germany (2)

03 Japan (1)

04 South Korea (1)

05 Switzerland (1)

06 United Kingdom (1)

URL Supplier Web Content
227MF10010
#81, Sanggae-Ro, Nam-Gu, Ulsan, Kor...
2015-01-05
2015-01-05
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223MF10118
4th and 5th Floors, 2 Stockport Exc...
2016-12-14
2011-07-25
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217MF10441
363 Tokutomi, Akaiwa City, Okayama ...
2020-06-11
2005-08-19
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227MF10158
30-5 Dongsunonggongdanji-gil, Naju-...
2016-07-15
2015-06-18
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303MF10106
No. 37 Section 6, North Chengdu Ave...
2023-08-09
2021-07-09
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228MF10081
Am Kraftwerk 6,66450 Bexbach, Germa...
2016-04-06
2016-04-06
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303MF10048
Am Kraftwerk 6,66450 Bexbach, Germa...
2021-03-17
2021-03-17
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305MF10044
No. 1, Lutai Road, High-tech Distri...
2023-04-05
2023-04-05
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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 JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Eicosapentaenoic Acid Drug Master File in Japan (Eicosapentaenoic Acid JDMF) empowers Eicosapentaenoic Acid API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Eicosapentaenoic Acid JDMF during the approval evaluation for pharmaceutical products. At the time of Eicosapentaenoic Acid JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

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

Eicosapentaenoic Acid Manufacturers | Traders | Suppliers

Eicosapentaenoic Acid Manufacturers, Traders, Suppliers 1
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We have 8 companies offering Eicosapentaenoic Acid

Get in contact with the supplier of your choice:

  1. AK & MN BioFarm
  2. BASF
  3. Bizen Chemical Co. - Ltd
  4. Chemport Inc
  5. Huatai Pharma
  6. K.D. Pharma Bexbach GmbH
  7. KD Pharma Group
  8. Shandong Xinhua Pharmaceutical
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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