01 4Tateyama Chemical Co., Ltd.
01 2Outsider regulations thioctic acid amide (manufactured only)
02 2Thioctic acid
01 4Japan
Extra-regional regulation: Thioctic acid amide (for manufacturing purposes 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
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
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-regional regulation: Thioctic acid amide (for manufacturing purposes 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
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A Viatris Brand of Thioctic Acid Tromethamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Viatris Brand of Thioctic Acid Tromethamine, including repackagers and relabelers. The FDA regulates Viatris Brand of Thioctic Acid Tromethamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Viatris Brand of Thioctic Acid Tromethamine 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 Viatris Brand of Thioctic Acid Tromethamine supplier is an individual or a company that provides Viatris Brand of Thioctic Acid Tromethamine active pharmaceutical ingredient (API) or Viatris Brand of Thioctic Acid Tromethamine finished formulations upon request. The Viatris Brand of Thioctic Acid Tromethamine suppliers may include Viatris Brand of Thioctic Acid Tromethamine 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 Viatris Brand of Thioctic Acid Tromethamine Drug Master File in Japan (Viatris Brand of Thioctic Acid Tromethamine JDMF) empowers Viatris Brand of Thioctic Acid Tromethamine 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 Viatris Brand of Thioctic Acid Tromethamine JDMF during the approval evaluation for pharmaceutical products. At the time of Viatris Brand of Thioctic Acid Tromethamine 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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