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-ku, Tokyo
Initial Date of Registration : 2015-04-30
Latest Date of Registration : 2016-06-24
Japanese Pharmacopoeia Benzethonium Chloride (for manufacturing purposes only)
Registration Number : 218MF10343
Registrant's Address : 4-4-16 Nihonbashi Honcho, Chuo-ku, 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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PharmaCompass also assists you with knowing the Benzethonium Chloride API Price utilized in the formulation of products. Benzethonium Chloride API Price is not always fixed or binding as the Benzethonium Chloride Price is obtained through a variety of data sources. The Benzethonium Chloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A QAC manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of QAC, including repackagers and relabelers. The FDA regulates QAC manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. QAC 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 QAC supplier is an individual or a company that provides QAC active pharmaceutical ingredient (API) or QAC finished formulations upon request. The QAC suppliers may include QAC 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 QAC Drug Master File in Japan (QAC JDMF) empowers QAC 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 QAC JDMF during the approval evaluation for pharmaceutical products. At the time of QAC 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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