01 2Toyama Pharmaceutical Co., Ltd.
01 1Japanese Pharmacopoeia borax (powder) (production only)
02 1Japanese Pharmacopoeia borax (production only)
01 2Japan
Japanese Pharmacopoeia Borax (for manufacturing only)
Registration Number : 219MF10069
Registrant's Address : Kyodo Building, 1-2-6 Honmachi, Nihonbashi, Chuo-ku, Tokyo (Honmachi)
Initial Date of Registration : 2007-03-05
Latest Date of Registration : 2007-03-05
Japanese Pharmacopoeia Borax (powder) (for manufacturing only)
Registration Number : 219MF10068
Registrant's Address : Kyodo Building, 1-2-6 Honmachi, Nihonbashi, Chuo-ku, Tokyo (Honmachi)
Initial Date of Registration : 2007-03-05
Latest Date of Registration : 2007-03-05
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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.
The Boric acid - Sodium tetraborate buffer solution Drug Master File in Japan (Boric acid - Sodium tetraborate buffer solution JDMF) empowers Boric acid - Sodium tetraborate buffer solution 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 Boric acid - Sodium tetraborate buffer solution JDMF during the approval evaluation for pharmaceutical products. At the time of Boric acid - Sodium tetraborate buffer solution 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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