01 1Kongo Chemical Co., Ltd.
01 1Nitric acid Bisuchiamin (production only)
01 1Japan
Bisthiamin nitrate (for manufacturing purposes only)
Registration Number : 217MF11210
Registrant's Address : 3 Himata, Toyama City, Toyama Prefecture
Initial Date of Registration : 2005-12-12
Latest Date of Registration : 2010-03-09
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A Nitrogen hydroxide oxide (N(OH)2O) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nitrogen hydroxide oxide (N(OH)2O), including repackagers and relabelers. The FDA regulates Nitrogen hydroxide oxide (N(OH)2O) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nitrogen hydroxide oxide (N(OH)2O) 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 Nitrogen hydroxide oxide (N(OH)2O) supplier is an individual or a company that provides Nitrogen hydroxide oxide (N(OH)2O) active pharmaceutical ingredient (API) or Nitrogen hydroxide oxide (N(OH)2O) finished formulations upon request. The Nitrogen hydroxide oxide (N(OH)2O) suppliers may include Nitrogen hydroxide oxide (N(OH)2O) API manufacturers, exporters, distributors and traders.
click here to find a list of Nitrogen hydroxide oxide (N(OH)2O) 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 Nitrogen hydroxide oxide (N(OH)2O) Drug Master File in Japan (Nitrogen hydroxide oxide (N(OH)2O) JDMF) empowers Nitrogen hydroxide oxide (N(OH)2O) 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 Nitrogen hydroxide oxide (N(OH)2O) JDMF during the approval evaluation for pharmaceutical products. At the time of Nitrogen hydroxide oxide (N(OH)2O) 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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