01 4Tateyama Chemical Co., Ltd.
01 2Outsider regulations thioctic acid amide (manufactured only)
02 2Thioctic acid
01 4Japan
Non-pharmaceutical standard thioctic acid amide (for manufacturing only)
Registration Number : 217MF10340
Registrant's Address : 1133 Ōe, 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 Ōe, 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 Ōe, Imizu City, Toyama Prefecture
Initial Date of Registration : 2005-07-21
Latest Date of Registration : 2009-09-28
Non-pharmaceutical standard thioctic acid amide (for manufacturing only)
Registration Number : 227MF10162
Registrant's Address : 1133 Ōe, Imizu City, Toyama Prefecture
Initial Date of Registration : 2015-06-18
Latest Date of Registration : 2015-06-18
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A biomo lipon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of biomo lipon, including repackagers and relabelers. The FDA regulates biomo lipon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. biomo lipon 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 biomo lipon supplier is an individual or a company that provides biomo lipon active pharmaceutical ingredient (API) or biomo lipon finished formulations upon request. The biomo lipon suppliers may include biomo lipon 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 biomo lipon Drug Master File in Japan (biomo lipon JDMF) empowers biomo lipon 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 biomo lipon JDMF during the approval evaluation for pharmaceutical products. At the time of biomo lipon 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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