01 2Kao Corporation
01 1SANISOL C
02 1SANISOL L-80
01 2Japan
Registration Number : 217MF10004
Registrant's Address : 1-14-10 Nihonbashi Kayabacho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-05-18
Latest Date of Registration : 2007-07-02
Registration Number : 217MF10005
Registrant's Address : 1-14-10 Nihonbashi Kayabacho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-05-18
Latest Date of Registration : 2021-10-21
A Cetalkonium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cetalkonium, including repackagers and relabelers. The FDA regulates Cetalkonium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cetalkonium API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Cetalkonium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cetalkonium supplier is an individual or a company that provides Cetalkonium active pharmaceutical ingredient (API) or Cetalkonium finished formulations upon request. The Cetalkonium suppliers may include Cetalkonium API manufacturers, exporters, distributors and traders.
click here to find a list of Cetalkonium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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 Cetalkonium Drug Master File in Japan (Cetalkonium JDMF) empowers Cetalkonium 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 Cetalkonium JDMF during the approval evaluation for pharmaceutical products. At the time of Cetalkonium 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 Cetalkonium suppliers with JDMF on PharmaCompass.
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