01 1Juzen Chemical Co., Ltd.
01 1Breakfast class crepe de Chine sodium (production only)
01 1Japan
Bucladesine sodium (for manufacturing purposes only)
Registration Number : 217MF10009
Registrant's Address : 1-10 Kibacho, Toyama City, Toyama Prefecture
Initial Date of Registration : 2005-05-18
Latest Date of Registration : 2012-06-01
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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 Sodium Dibutyryl Camp Drug Master File in Japan (Sodium Dibutyryl Camp JDMF) empowers Sodium Dibutyryl Camp 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 Sodium Dibutyryl Camp JDMF during the approval evaluation for pharmaceutical products. At the time of Sodium Dibutyryl Camp 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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