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 Trusopt, Cosopt,Dorzolamide HCL Drug Master File in Japan (Trusopt, Cosopt,Dorzolamide HCL JDMF) empowers Trusopt, Cosopt,Dorzolamide HCL 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 Trusopt, Cosopt,Dorzolamide HCL JDMF during the approval evaluation for pharmaceutical products. At the time of Trusopt, Cosopt,Dorzolamide HCL 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 Trusopt, Cosopt,Dorzolamide HCL suppliers with JDMF on PharmaCompass.