01 1Juzen Chemical Co., Ltd.
01 1Thiopental sodium
01 1Japan
Registration Number : 217MF10011
Registrant's Address : 1-10 Kiba-cho, Toyama City, Toyama Prefecture
Initial Date of Registration : 2005-05-18
Latest Date of Registration : 2007-10-24
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A Tiobarbital Braun manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tiobarbital Braun, including repackagers and relabelers. The FDA regulates Tiobarbital Braun manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tiobarbital Braun 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 Tiobarbital Braun supplier is an individual or a company that provides Tiobarbital Braun active pharmaceutical ingredient (API) or Tiobarbital Braun finished formulations upon request. The Tiobarbital Braun suppliers may include Tiobarbital Braun 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 Tiobarbital Braun Drug Master File in Japan (Tiobarbital Braun JDMF) empowers Tiobarbital Braun 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 Tiobarbital Braun JDMF during the approval evaluation for pharmaceutical products. At the time of Tiobarbital Braun 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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