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 Aspirin (Acetyl Salicylic Acid), Pharmaceutical Secondary Standard; Certified Reference Material Drug Master File in Japan (Aspirin (Acetyl Salicylic Acid), Pharmaceutical Secondary Standard; Certified Reference Material JDMF) empowers Aspirin (Acetyl Salicylic Acid), Pharmaceutical Secondary Standard; Certified Reference Material 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 Aspirin (Acetyl Salicylic Acid), Pharmaceutical Secondary Standard; Certified Reference Material JDMF during the approval evaluation for pharmaceutical products. At the time of Aspirin (Acetyl Salicylic Acid), Pharmaceutical Secondary Standard; Certified Reference Material 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 Aspirin (Acetyl Salicylic Acid), Pharmaceutical Secondary Standard; Certified Reference Material suppliers with JDMF on PharmaCompass.