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01 1Ajinomoto Co., Inc.
02 1CHANGZHOU YABANG PHARMACEUTICAL CO. , LTD.
03 2Kanto Chemical Co., Ltd.
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01 1Ecabet Sodium Hydrate
02 1Sodium hydroxide
03 1Sodium hydroxide (UE-E)
04 1Upacyclet sodium hydrate
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01 1China
02 3Japan
Registration Number : 302MF10078
Registrant's Address : 1-15-1 Kyobashi, Chuo-ku, Tokyo
Initial Date of Registration : 2020-07-06
Latest Date of Registration : 2020-07-06
Registration Number : 227MF10264
Registrant's Address : Liangchang East Road 6#, Jintan, Jiangsu Province, P. R. China
Initial Date of Registration : 2015-11-12
Latest Date of Registration : 2015-11-12
Registration Number : 222MF10183
Registrant's Address : 3-2-8 Nihonbashi Honcho, Chuo-ku, Tokyo
Initial Date of Registration : 2010-06-25
Latest Date of Registration : 2010-06-25
Registration Number : 222MF10182
Registrant's Address : 3-2-8 Nihonbashi Honcho, Chuo-ku, Tokyo
Initial Date of Registration : 2010-06-25
Latest Date of Registration : 2010-06-25
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PharmaCompass offers a list of Sodium Hydroxide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Sodium Hydroxide manufacturer or Sodium Hydroxide supplier for your needs.
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A Lewis-red devil lye manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lewis-red devil lye, including repackagers and relabelers. The FDA regulates Lewis-red devil lye manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lewis-red devil lye 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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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 Lewis-red devil lye Drug Master File in Japan (Lewis-red devil lye JDMF) empowers Lewis-red devil lye 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 Lewis-red devil lye JDMF during the approval evaluation for pharmaceutical products. At the time of Lewis-red devil lye 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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