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 4-Guanidino-benzoic acid 4-dimethylcarbamoylmethoxycarbonylmethyl-phenyl ester; compound with methanesulfonic acid Drug Master File in Japan (4-Guanidino-benzoic acid 4-dimethylcarbamoylmethoxycarbonylmethyl-phenyl ester; compound with methanesulfonic acid JDMF) empowers 4-Guanidino-benzoic acid 4-dimethylcarbamoylmethoxycarbonylmethyl-phenyl ester; compound with methanesulfonic acid 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 4-Guanidino-benzoic acid 4-dimethylcarbamoylmethoxycarbonylmethyl-phenyl ester; compound with methanesulfonic acid JDMF during the approval evaluation for pharmaceutical products. At the time of 4-Guanidino-benzoic acid 4-dimethylcarbamoylmethoxycarbonylmethyl-phenyl ester; compound with methanesulfonic acid 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 4-Guanidino-benzoic acid 4-dimethylcarbamoylmethoxycarbonylmethyl-phenyl ester; compound with methanesulfonic acid suppliers with JDMF on PharmaCompass.