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