01 1Fatty Chemical (Malaysia) Sdn. Bhd.
02 1Kao Corporation
03 2Kashima Chemical Co., Ltd.
04 2NOF Corporation
05 2New Japan Chemical Co., Ltd.
06 2Sakamoto Pharmaceutical Co., Ltd.
01 5Japanese Pharmacopoeia concentrated glycerin
02 5Japanese Pharmacopoeia glycerin
01 10Japan
Japanese Pharmacopoeia Concentrated Glycerin
Registration Number : 222MF10125
Registrant's Address : 2510, LORONG PERUSAHAAN SATU, PRAI INDUSTRIAL COMPLEX, 13600 PRAI, PENANG, MALAYSIA
Initial Date of Registration : 2010-04-05
Latest Date of Registration : 2010-04-05
Japanese Pharmacopoeia Glycerin
Registration Number : 222MF10072
Registrant's Address : 1-14-10 Nihonbashi Kayabacho, Chuo-ku, Tokyo
Initial Date of Registration : 2010-02-25
Latest Date of Registration : 2010-02-25
Japanese Pharmacopoeia Glycerin
Registration Number : 218MF10654
Registrant's Address : 30 Higashiwada, Kamisu City, Ibaraki Prefecture
Initial Date of Registration : 2006-07-24
Latest Date of Registration : 2006-07-24
Japanese Pharmacopoeia Concentrated Glycerin
Registration Number : 218MF10353
Registrant's Address : 30 Higashiwada, Kamisu City, Ibaraki Prefecture
Initial Date of Registration : 2006-03-17
Latest Date of Registration : 2006-03-17
Registration Number : 218MF10910
Registrant's Address : 13, Kashima Yagura-cho, Fushimi-ku, Kyoto City, Kyoto Prefecture
Initial Date of Registration : 2006-11-10
Latest Date of Registration : 2006-11-10
Pharmacopoeial concentrated glycerin
Registration Number : 218MF10909
Registrant's Address : 13, Kashima Yagura-cho, Fushimi-ku, Kyoto City, Kyoto Prefecture
Initial Date of Registration : 2006-11-10
Latest Date of Registration : 2006-11-10
Japanese Pharmacopoeia Concentrated Glycerin
Registration Number : 217MF11163
Registrant's Address : 20-3 Ebisu 4-chome, Shibuya-ku, Tokyo
Initial Date of Registration : 2005-12-12
Latest Date of Registration : 2010-04-02
Japanese Pharmacopoeia Glycerin
Registration Number : 217MF11162
Registrant's Address : 20-3 Ebisu 4-chome, Shibuya-ku, Tokyo
Initial Date of Registration : 2005-12-12
Latest Date of Registration : 2010-04-02
Japanese Pharmacopoeia Concentrated Glycerin
Registration Number : 217MF10845
Registrant's Address : Osaka Prefecture, Osaka City, Chuo Ward, Awajicho 1-2-6
Initial Date of Registration : 2005-11-01
Latest Date of Registration : 2022-09-14
Japanese Pharmacopoeia Glycerin
Registration Number : 217MF10844
Registrant's Address : Osaka Prefecture, Osaka City, Chuo Ward, Awajicho 1-2-6
Initial Date of Registration : 2005-11-01
Latest Date of Registration : 2022-09-14
A 1,2,3-Propanetriol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1,2,3-Propanetriol, including repackagers and relabelers. The FDA regulates 1,2,3-Propanetriol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1,2,3-Propanetriol API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A 1,2,3-Propanetriol supplier is an individual or a company that provides 1,2,3-Propanetriol active pharmaceutical ingredient (API) or 1,2,3-Propanetriol finished formulations upon request. The 1,2,3-Propanetriol suppliers may include 1,2,3-Propanetriol API manufacturers, exporters, distributors and traders.
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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 1,2,3-Propanetriol Drug Master File in Japan (1,2,3-Propanetriol JDMF) empowers 1,2,3-Propanetriol 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 1,2,3-Propanetriol JDMF during the approval evaluation for pharmaceutical products. At the time of 1,2,3-Propanetriol 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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