01 4Tateyama Chemical Co., Ltd.
01 2Outsider regulations thioctic acid amide (manufactured only)
02 2Thioctic acid
01 4Japan
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
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
A (.+-.)-Thioctic acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (.+-.)-Thioctic acid, including repackagers and relabelers. The FDA regulates (.+-.)-Thioctic acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (.+-.)-Thioctic acid API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of (.+-.)-Thioctic acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A (.+-.)-Thioctic acid supplier is an individual or a company that provides (.+-.)-Thioctic acid active pharmaceutical ingredient (API) or (.+-.)-Thioctic acid finished formulations upon request. The (.+-.)-Thioctic acid suppliers may include (.+-.)-Thioctic acid API manufacturers, exporters, distributors and traders.
click here to find a list of (.+-.)-Thioctic acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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 (.+-.)-Thioctic acid Drug Master File in Japan ((.+-.)-Thioctic acid JDMF) empowers (.+-.)-Thioctic acid 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 (.+-.)-Thioctic acid JDMF during the approval evaluation for pharmaceutical products. At the time of (.+-.)-Thioctic acid JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of (.+-.)-Thioctic acid suppliers with JDMF on PharmaCompass.
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