01 1AK BIOPHARM CO. , LTD.
02 1BASF Pharma (Callanish) Ltd.
03 1Bizen Chemical Co., Ltd.
04 1Chemport Inc.
05 1Huatai Pharma Inc.
06 2K. D. Pharma Bexbach GmbH
07 1Shandong Xinhua Pharmaceutical Co. , Ltd.
01 1Aye Kay & M N. bio farm Ikosapenteto (raw material) (for export)
02 1ETHYL ICOSAPENTATE
03 1Eicosapentaenoic San EQ
04 2Eicosapentaenoic acid ethyl
05 2Ethyl icosapentaenoate
06 1Makusomega EPA97EE
01 2China
02 2Germany
03 1Japan
04 1South Korea
05 1Switzerland
06 1United Kingdom
AK&MN Biofarm Eicosapentate (raw material) (for export)
Registration Number : 227MF10010
Registrant's Address : #81, Sanggae-Ro, Nam-Gu, Ulsan, Korea
Initial Date of Registration : 2015-01-05
Latest Date of Registration : 2015-01-05
Registration Number : 223MF10118
Registrant's Address : 4th and 5th Floors, 2 Stockport Exchange, Railway Road, Stockport, SK1 3GG, UK
Initial Date of Registration : 2011-07-25
Latest Date of Registration : 2016-12-14
Registration Number : 217MF10441
Registrant's Address : 363 Tokutomi, Akaiwa City, Okayama Prefecture
Initial Date of Registration : 2005-08-19
Latest Date of Registration : 2020-06-11
Registration Number : 227MF10158
Registrant's Address : 30-5 Dongsunonggongdanji-gil, Naju-si, Jeollanam-do 58275, Korea
Initial Date of Registration : 2015-06-18
Latest Date of Registration : 2016-07-15
Registration Number : 303MF10106
Registrant's Address : No. 37 Section 6, North Chengdu Avenue, Guanghan, Deyang City, Sichuan Province P. R....
Initial Date of Registration : 2021-07-09
Latest Date of Registration : 2023-08-09
Registration Number : 228MF10081
Registrant's Address : Am Kraftwerk 6,66450 Bexbach, Germany
Initial Date of Registration : 2016-04-06
Latest Date of Registration : 2016-04-06
Registration Number : 303MF10048
Registrant's Address : Am Kraftwerk 6,66450 Bexbach, Germany
Initial Date of Registration : 2021-03-17
Latest Date of Registration : 2021-03-17
Registration Number : 305MF10044
Registrant's Address : No. 1, Lutai Road, High-tech District, Zibo, Shandong, P. R. China
Initial Date of Registration : 2023-04-05
Latest Date of Registration : 2023-04-05
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.
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.
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 Icosapent Ethyl Drug Master File in Japan (Icosapent Ethyl JDMF) empowers Icosapent Ethyl 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 Icosapent Ethyl JDMF during the approval evaluation for pharmaceutical products. At the time of Icosapent Ethyl 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 Icosapent Ethyl suppliers with JDMF on PharmaCompass.
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