01 1Tateyama Chemical Co., Ltd.
01 1Oct thiamine (Tateyama
01 1Japan
Registration Number : 217MF10337
Registrant's Address : 1133 Ōe, Imizu City, Toyama Prefecture
Initial Date of Registration : 2005-07-21
Latest Date of Registration : 2010-03-23
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A C12H17N4OS manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of C12H17N4OS, including repackagers and relabelers. The FDA regulates C12H17N4OS manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. C12H17N4OS API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A C12H17N4OS supplier is an individual or a company that provides C12H17N4OS active pharmaceutical ingredient (API) or C12H17N4OS finished formulations upon request. The C12H17N4OS suppliers may include C12H17N4OS API manufacturers, exporters, distributors and traders.
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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 C12H17N4OS Drug Master File in Japan (C12H17N4OS JDMF) empowers C12H17N4OS 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 C12H17N4OS JDMF during the approval evaluation for pharmaceutical products. At the time of C12H17N4OS JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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