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 Adenine polynucleotides Drug Master File in Japan (Adenine polynucleotides JDMF) empowers Adenine polynucleotides 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 Adenine polynucleotides JDMF during the approval evaluation for pharmaceutical products. At the time of Adenine polynucleotides 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 Adenine polynucleotides suppliers with JDMF on PharmaCompass.