01 1Hamari PFST Co., Ltd.
02 1Kongo Chemical Co., Ltd.
01 1Benfotiamine "Yonezawa"
02 1Benfotiamine (production only)
01 2Japan
Benfotiamine (for manufacturing purposes only)
Registration Number : 217MF11200
Registrant's Address : 3 Himata, Toyama City, Toyama Prefecture
Initial Date of Registration : 2005-12-12
Latest Date of Registration : 2007-05-15
Registration Number : 217MF10852
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 : 2007-04-27
A Benfotiamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benfotiamine, including repackagers and relabelers. The FDA regulates Benfotiamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benfotiamine 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 Benfotiamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Benfotiamine supplier is an individual or a company that provides Benfotiamine active pharmaceutical ingredient (API) or Benfotiamine finished formulations upon request. The Benfotiamine suppliers may include Benfotiamine API manufacturers, exporters, distributors and traders.
click here to find a list of Benfotiamine 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 Benfotiamine Drug Master File in Japan (Benfotiamine JDMF) empowers Benfotiamine 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 Benfotiamine JDMF during the approval evaluation for pharmaceutical products. At the time of Benfotiamine 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 Benfotiamine suppliers with JDMF on PharmaCompass.
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