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 Denatured alcohol SD-39b Drug Master File in Japan (Denatured alcohol SD-39b JDMF) empowers Denatured alcohol SD-39b 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 Denatured alcohol SD-39b JDMF during the approval evaluation for pharmaceutical products. At the time of Denatured alcohol SD-39b 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 Denatured alcohol SD-39b suppliers with JDMF on PharmaCompass.