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 Teofarma Brand of Tinidazole Drug Master File in Japan (Teofarma Brand of Tinidazole JDMF) empowers Teofarma Brand of Tinidazole 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 Teofarma Brand of Tinidazole JDMF during the approval evaluation for pharmaceutical products. At the time of Teofarma Brand of Tinidazole JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Teofarma Brand of Tinidazole suppliers with JDMF on PharmaCompass.