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 Alpha Lipoic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alpha Lipoic Acid, including repackagers and relabelers. The FDA regulates Alpha Lipoic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alpha Lipoic 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.
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A Alpha Lipoic Acid supplier is an individual or a company that provides Alpha Lipoic Acid active pharmaceutical ingredient (API) or Alpha Lipoic Acid finished formulations upon request. The Alpha Lipoic Acid suppliers may include Alpha Lipoic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Alpha Lipoic 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 Alpha Lipoic Acid Drug Master File in Japan (Alpha Lipoic Acid JDMF) empowers Alpha Lipoic 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 Alpha Lipoic Acid JDMF during the approval evaluation for pharmaceutical products. At the time of Alpha Lipoic 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 Alpha Lipoic Acid suppliers with JDMF on PharmaCompass.
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