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 alpha-Amino-4(or 5)-imidazolepropionic acid Drug Master File in Japan (alpha-Amino-4(or 5)-imidazolepropionic acid JDMF) empowers alpha-Amino-4(or 5)-imidazolepropionic 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 alpha-Amino-4(or 5)-imidazolepropionic acid JDMF during the approval evaluation for pharmaceutical products. At the time of alpha-Amino-4(or 5)-imidazolepropionic 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 alpha-Amino-4(or 5)-imidazolepropionic acid suppliers with JDMF on PharmaCompass.