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 Tocopheryl Acetate, dl-Alpha Drug Master File in Japan (Tocopheryl Acetate, dl-Alpha JDMF) empowers Tocopheryl Acetate, dl-Alpha 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 Tocopheryl Acetate, dl-Alpha JDMF during the approval evaluation for pharmaceutical products. At the time of Tocopheryl Acetate, dl-Alpha 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 Tocopheryl Acetate, dl-Alpha suppliers with JDMF on PharmaCompass.