01 1Active Pharma Co., Ltd.
01 1Japanese Pharmacopoeia tolnaftate (production only)
01 1Japan
Japanese Pharmacopoeia Tolnaftate (for manufacturing purposes only)
Registration Number : 217MF10195
Registrant's Address : 2-36-1 Kanda Jinbocho, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-06-08
Latest Date of Registration : 2020-06-04
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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.
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PMDA reviews the Tinactin jock itch cream JDMF during the approval evaluation for pharmaceutical products. At the time of Tinactin jock itch cream JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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