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 Allergan Brand of Flurbiprofen Sodium Drug Master File in Japan (Allergan Brand of Flurbiprofen Sodium JDMF) empowers Allergan Brand of Flurbiprofen Sodium 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 Allergan Brand of Flurbiprofen Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Allergan Brand of Flurbiprofen Sodium 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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