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
A Hyamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hyamine, including repackagers and relabelers. The FDA regulates Hyamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hyamine 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 Hyamine supplier is an individual or a company that provides Hyamine active pharmaceutical ingredient (API) or Hyamine finished formulations upon request. The Hyamine suppliers may include Hyamine 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 Hyamine Drug Master File in Japan (Hyamine JDMF) empowers Hyamine 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 Hyamine JDMF during the approval evaluation for pharmaceutical products. At the time of Hyamine 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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