01 4Tateyama Chemical Co., Ltd.
01 2Outsider regulations thioctic acid amide (manufactured only)
02 2Thioctic acid
01 4Japan
Registration Number : 222MF10195
Registrant's Address : 1133 Oe, Imizu City, Toyama Prefecture
Initial Date of Registration : 2010-07-13
Latest Date of Registration : 2010-07-13
Extra-official regulations Thioctic acid amide (for manufacturing only)
Registration Number : 227MF10162
Registrant's Address : 1133 Oe, Imizu City, Toyama Prefecture
Initial Date of Registration : 2015-06-18
Latest Date of Registration : 2015-06-18
Registration Number : 217MF10341
Registrant's Address : 1133 Oe, Imizu City, Toyama Prefecture
Initial Date of Registration : 2005-07-21
Latest Date of Registration : 2009-09-28
Extra-official regulations Thioctic acid amide (for manufacturing only)
Registration Number : 217MF10340
Registrant's Address : 1133 Oe, Imizu City, Toyama Prefecture
Initial Date of Registration : 2005-07-21
Latest Date of Registration : 2010-02-16
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A Protogen A manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Protogen A, including repackagers and relabelers. The FDA regulates Protogen A manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Protogen A 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 Protogen A supplier is an individual or a company that provides Protogen A active pharmaceutical ingredient (API) or Protogen A finished formulations upon request. The Protogen A suppliers may include Protogen A 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 Protogen A Drug Master File in Japan (Protogen A JDMF) empowers Protogen A API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
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