01 2Junsei Chemical Co., Ltd.
02 1Organo Syntesis, S. A. de C. V.
01 1Benzethonium chloride
02 1Japanese Pharmacopoeia benzethonium chloride
03 1Japanese Pharmacopoeia benzethonium chloride (production only)
01 2Japan
02 1Mexico
Japanese Pharmacopoeia Benzethonium Chloride
Registration Number : 227MF10131
Registrant's Address : 4-4-16 Nihonbashi Honcho, Chuo Ward, Tokyo
Initial Date of Registration : 2015-04-30
Latest Date of Registration : 2016-06-24
Japanese Pharmacopoeia Benzethonium Chloride (for manufacturing only)
Registration Number : 218MF10343
Registrant's Address : 4-4-16 Nihonbashi Honcho, Chuo Ward, Tokyo
Initial Date of Registration : 2006-03-09
Latest Date of Registration : 2010-02-12
Registration Number : 223MF10086
Registrant's Address : Paseo de las Palmas #735-908 Lomas de Chapultepec 11000 Mexico, D. F.
Initial Date of Registration : 2011-06-17
Latest Date of Registration : 2015-12-15
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PharmaCompass offers a list of Benzethonium Chloride 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 Benzethonium Chloride manufacturer or Benzethonium Chloride supplier for your needs.
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A Benzethonium Chloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benzethonium Chloride, including repackagers and relabelers. The FDA regulates Benzethonium Chloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benzethonium Chloride 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 Benzethonium Chloride supplier is an individual or a company that provides Benzethonium Chloride active pharmaceutical ingredient (API) or Benzethonium Chloride finished formulations upon request. The Benzethonium Chloride suppliers may include Benzethonium Chloride 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 Benzethonium Chloride Drug Master File in Japan (Benzethonium Chloride JDMF) empowers Benzethonium Chloride 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 Benzethonium Chloride JDMF during the approval evaluation for pharmaceutical products. At the time of Benzethonium Chloride 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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