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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PharmaCompass offers a list of Nitric Acid API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Nitric Acid manufacturer or Nitric Acid supplier for your needs.
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A Acido nitrico manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acido nitrico, including repackagers and relabelers. The FDA regulates Acido nitrico manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acido nitrico 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 Acido nitrico supplier is an individual or a company that provides Acido nitrico active pharmaceutical ingredient (API) or Acido nitrico finished formulations upon request. The Acido nitrico suppliers may include Acido nitrico 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 Acido nitrico Drug Master File in Japan (Acido nitrico JDMF) empowers Acido nitrico 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 Acido nitrico JDMF during the approval evaluation for pharmaceutical products. At the time of Acido nitrico 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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