01 1Active Pharma Inc.
02 1China Chemical Industry Co., Ltd.
03 2Hamari PFST Co., Ltd.
04 1Kanto Chemical Co., Ltd.
05 1Sanyo Chemical Research Institute Co., Ltd.
06 1Shionogi Pharma Co., Ltd.
01 7Edaravone
01 1Gabon
02 6Japan
Registration Number : 226MF10180
Registrant's Address : Osaka Prefecture, Osaka City, Suminoe Ward, Nanko Kita 1-19-40
Initial Date of Registration : 2014-09-01
Latest Date of Registration : 2022-05-06
Registration Number : 221MF10257
Registrant's Address : 1-6, Tenno Shioyacho, Kure City, Hiroshima Prefecture
Initial Date of Registration : 2009-11-30
Latest Date of Registration : 2010-10-12
Registration Number : 222MF10031
Registrant's Address : 3-2-8 Nihonbashi Honcho, Chuo-ku, Tokyo
Initial Date of Registration : 2010-01-26
Latest Date of Registration : 2010-10-08
Registration Number : 221MF10080
Registrant's Address : 2-36-1 Kanda Jinbocho, Chiyoda-ku, Tokyo
Initial Date of Registration : 2009-04-22
Latest Date of Registration : 2010-04-12
Registration Number : 221MF10258
Registrant's Address : 2-5-1 Mishima, Settsu City, Osaka Prefecture
Initial Date of Registration : 2009-11-30
Latest Date of Registration : 2010-10-08
Registration Number : 221MF10138
Registrant's Address : 148-1 Tajii, Mihara-ku, Sakai City, Osaka Prefecture
Initial Date of Registration : 2009-07-09
Latest Date of Registration : 2010-04-22
Registration Number : 221MF10269
Registrant's Address : Osaka Prefecture, Osaka City, Suminoe Ward, Nanko Kita 1-19-40
Initial Date of Registration : 2009-12-07
Latest Date of Registration : 2009-12-07
A Edaravone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Edaravone, including repackagers and relabelers. The FDA regulates Edaravone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Edaravone 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 Edaravone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Edaravone supplier is an individual or a company that provides Edaravone active pharmaceutical ingredient (API) or Edaravone finished formulations upon request. The Edaravone suppliers may include Edaravone API manufacturers, exporters, distributors and traders.
click here to find a list of Edaravone 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 Edaravone Drug Master File in Japan (Edaravone JDMF) empowers Edaravone 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 Edaravone JDMF during the approval evaluation for pharmaceutical products. At the time of Edaravone 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 Edaravone suppliers with JDMF on PharmaCompass.
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