01 1Ajinomoto Co., Inc.
02 2Kanto Chemical Co., Ltd.
03 2Katsura Chemical Co., Ltd.
04 1Permakem Asia Co., Ltd.
05 1Shizuoka Caffeine Industry Co., Ltd.
01 1Japanese Pharmacopoeia nafamostat mesylate (production only)
02 1Mesylate nafamostat
03 1Mesylate nafamostat - deer
04 1Nafamostat mesylate
05 1Nafamostat mesylate - deer
06 1Nafamostat mesylate -A
07 1Nafamostat mesylate -K
01 7Japan
Registration Number : 226MF10002
Registrant's Address : 1-15-1 Kyobashi, Chuo-ku, Tokyo
Initial Date of Registration : 2014-01-08
Latest Date of Registration : 2014-01-08
Registration Number : 220MF10222
Registrant's Address : 3-2-8 Nihonbashi Honcho, Chuo-ku, Tokyo
Initial Date of Registration : 2008-11-04
Latest Date of Registration : 2021-02-24
Registration Number : 218MF10299
Registrant's Address : 3-2-8 Nihonbashi Honcho, Chuo-ku, Tokyo
Initial Date of Registration : 2006-02-28
Latest Date of Registration : 2006-11-06
Registration Number : 220MF10201
Registrant's Address : 4-15-19 Hibarigaoka, Zama City, Kanagawa Prefecture
Initial Date of Registration : 2008-09-19
Latest Date of Registration : 2008-09-19
Registration Number : 223MF10091
Registrant's Address : 4-15-19 Hibarigaoka, Zama City, Kanagawa Prefecture
Initial Date of Registration : 2011-06-29
Latest Date of Registration : 2011-06-29
Japanese Pharmacopoeia Nafamostat Mesilate (for manufacturing only)
Registration Number : 220MF10115
Registrant's Address : 129 Suidocho, Aoi Ward, Shizuoka City, Shizuoka Prefecture
Initial Date of Registration : 2008-04-21
Latest Date of Registration : 2008-04-21
Registration Number : 217MF11135
Registrant's Address : 1-10-11, Nihonbashi Horidomecho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-12-05
Latest Date of Registration : 2006-04-27
A Nafamostat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nafamostat, including repackagers and relabelers. The FDA regulates Nafamostat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nafamostat 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 Nafamostat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nafamostat supplier is an individual or a company that provides Nafamostat active pharmaceutical ingredient (API) or Nafamostat finished formulations upon request. The Nafamostat suppliers may include Nafamostat API manufacturers, exporters, distributors and traders.
click here to find a list of Nafamostat 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 Nafamostat Drug Master File in Japan (Nafamostat JDMF) empowers Nafamostat 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 Nafamostat JDMF during the approval evaluation for pharmaceutical products. At the time of Nafamostat 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 Nafamostat suppliers with JDMF on PharmaCompass.
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