01 1Kongo Chemical Co., Ltd.
01 1Thiamine disulfide (production only)
01 1Japan
Thiamine Disulfide (for manufacturing purposes only)
Registration Number : 217MF11195
Registrant's Address : 3 Himata, Toyama City, Toyama Prefecture
Initial Date of Registration : 2005-12-12
Latest Date of Registration : 2008-06-23
A Sulbutiamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sulbutiamine, including repackagers and relabelers. The FDA regulates Sulbutiamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sulbutiamine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Sulbutiamine supplier is an individual or a company that provides Sulbutiamine active pharmaceutical ingredient (API) or Sulbutiamine finished formulations upon request. The Sulbutiamine suppliers may include Sulbutiamine API manufacturers, exporters, distributors and traders.
click here to find a list of Sulbutiamine 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 Sulbutiamine Drug Master File in Japan (Sulbutiamine JDMF) empowers Sulbutiamine 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 Sulbutiamine JDMF during the approval evaluation for pharmaceutical products. At the time of Sulbutiamine 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 Sulbutiamine suppliers with JDMF on PharmaCompass.
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