01 1Tateyama Chemical Co., Ltd.
01 1Oct thiamine (Tateyama
01 1Japan
Registration Number : 217MF10337
Registrant's Address : 1133 Ōe, Imizu City, Toyama Prefecture
Initial Date of Registration : 2005-07-21
Latest Date of Registration : 2010-03-23
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A Tiaminal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tiaminal, including repackagers and relabelers. The FDA regulates Tiaminal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tiaminal 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 Tiaminal manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Tiaminal supplier is an individual or a company that provides Tiaminal active pharmaceutical ingredient (API) or Tiaminal finished formulations upon request. The Tiaminal suppliers may include Tiaminal API manufacturers, exporters, distributors and traders.
click here to find a list of Tiaminal suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 Tiaminal Drug Master File in Japan (Tiaminal JDMF) empowers Tiaminal 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 Tiaminal JDMF during the approval evaluation for pharmaceutical products. At the time of Tiaminal 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 Tiaminal suppliers with JDMF on PharmaCompass.
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