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 Spectracef , Meiact, Cefditoren pivoxil Drug Master File in Japan (Spectracef , Meiact, Cefditoren pivoxil JDMF) empowers Spectracef , Meiact, Cefditoren pivoxil 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 Spectracef , Meiact, Cefditoren pivoxil JDMF during the approval evaluation for pharmaceutical products. At the time of Spectracef , Meiact, Cefditoren pivoxil 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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