01 1Hamari PFST Co., Ltd.
02 1ILDONG PHARMACEUTICAL CO. , LTD.
03 1Johko Pharmaceutical Co., Ltd.
04 1Kongo Chemical Co., Ltd.
05 3Mikuni Pharmaceutical Co., Ltd.
01 1Furusuruchiamin hydrochloride "production-only"
02 1Hydrochloric acid Furusuruchiamin (production only)
03 3Japanese Pharmacopoeia Furusuruchiamin hydrochloride (production only)
04 1Japanese Pharmacopoeia hydrochloric acid Furusuruchiamin (production only)
05 1Outsiders regulations Furusuruchiamin (production only)
01 6Japan
02 1South Korea
Fursultiamine hydrochloride (for manufacturing purposes only)
Registration Number : 225MF10177
Registrant's Address : 2. Baumoe-ro 27-gil, Seocho-gu, Seoul, Korea
Initial Date of Registration : 2013-09-18
Latest Date of Registration : 2013-09-18
Fursultiamine hydrochloride (for manufacturing only)
Registration Number : 217MF11203
Registrant's Address : 3 Himata, Toyama City, Toyama Prefecture
Initial Date of Registration : 2005-12-12
Latest Date of Registration : 2007-05-02
Japanese Pharmacopoeia Fursultiamine Hydrochloride (for manufacturing only)
Registration Number : 218MF11035
Registrant's Address : 2-35 Shinshu-cho, Toyonaka City, Osaka Prefecture
Initial Date of Registration : 2006-12-28
Latest Date of Registration : 2006-12-28
Extra-official regulations Fursultiamine (for manufacturing only)
Registration Number : 221MF10037
Registrant's Address : 2-35 Shinshu-cho, Toyonaka City, Osaka Prefecture
Initial Date of Registration : 2009-02-09
Latest Date of Registration : 2009-02-09
Japanese Pharmacopoeia Fursultiamine Hydrochloride (for manufacturing only)
Registration Number : 218MF10915
Registrant's Address : 2-35 Shinshu-cho, Toyonaka City, Osaka Prefecture
Initial Date of Registration : 2006-11-21
Latest Date of Registration : 2006-11-21
Japanese Pharmacopoeia Fursultiamine Hydrochloride (For manufacturing only)
Registration Number : 218MF10979
Registrant's Address : 5 Kajigaishi Nishi 1-chome, Kitanagoya City, Aichi Prefecture
Initial Date of Registration : 2006-12-01
Latest Date of Registration : 2006-12-01
Japanese Pharmacopoeia Fursultiamine Hydrochloride (for manufacturing only)
Registration Number : 217MF10856
Registrant's Address : Osaka Prefecture, Osaka City, Suminoe Ward, Nanko Kita 1-19-40
Initial Date of Registration : 2005-11-01
Latest Date of Registration : 2007-01-22
A Fursultiamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fursultiamine, including repackagers and relabelers. The FDA regulates Fursultiamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fursultiamine 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 Fursultiamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fursultiamine supplier is an individual or a company that provides Fursultiamine active pharmaceutical ingredient (API) or Fursultiamine finished formulations upon request. The Fursultiamine suppliers may include Fursultiamine API manufacturers, exporters, distributors and traders.
click here to find a list of Fursultiamine 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 Fursultiamine Drug Master File in Japan (Fursultiamine JDMF) empowers Fursultiamine 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 Fursultiamine JDMF during the approval evaluation for pharmaceutical products. At the time of Fursultiamine 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 Fursultiamine suppliers with JDMF on PharmaCompass.
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