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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PharmaCompass offers a list of Alpha Lipoic Acid API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Alpha Lipoic Acid manufacturer or Alpha Lipoic Acid supplier for your needs.
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A Thiogamma manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Thiogamma, including repackagers and relabelers. The FDA regulates Thiogamma manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Thiogamma 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 Thiogamma supplier is an individual or a company that provides Thiogamma active pharmaceutical ingredient (API) or Thiogamma finished formulations upon request. The Thiogamma suppliers may include Thiogamma 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 Thiogamma Drug Master File in Japan (Thiogamma JDMF) empowers Thiogamma 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 Thiogamma JDMF during the approval evaluation for pharmaceutical products. At the time of Thiogamma 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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