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