01 1NOF Corporation
01 1Nissan cation M2-100
01 1Japan
Registration Number : 220MF10240
Registrant's Address : 20-3 Ebisu 4-chome, Shibuya-ku, Tokyo
Initial Date of Registration : 2008-12-04
Latest Date of Registration : 2008-12-04
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A Quaternary ammonium compounds, benzyl-C12-C16-alkyldimethyl, chlorides manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Quaternary ammonium compounds, benzyl-C12-C16-alkyldimethyl, chlorides, including repackagers and relabelers. The FDA regulates Quaternary ammonium compounds, benzyl-C12-C16-alkyldimethyl, chlorides manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Quaternary ammonium compounds, benzyl-C12-C16-alkyldimethyl, chlorides 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 Quaternary ammonium compounds, benzyl-C12-C16-alkyldimethyl, chlorides supplier is an individual or a company that provides Quaternary ammonium compounds, benzyl-C12-C16-alkyldimethyl, chlorides active pharmaceutical ingredient (API) or Quaternary ammonium compounds, benzyl-C12-C16-alkyldimethyl, chlorides finished formulations upon request. The Quaternary ammonium compounds, benzyl-C12-C16-alkyldimethyl, chlorides suppliers may include Quaternary ammonium compounds, benzyl-C12-C16-alkyldimethyl, chlorides 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 Quaternary ammonium compounds, benzyl-C12-C16-alkyldimethyl, chlorides Drug Master File in Japan (Quaternary ammonium compounds, benzyl-C12-C16-alkyldimethyl, chlorides JDMF) empowers Quaternary ammonium compounds, benzyl-C12-C16-alkyldimethyl, chlorides 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 Quaternary ammonium compounds, benzyl-C12-C16-alkyldimethyl, chlorides JDMF during the approval evaluation for pharmaceutical products. At the time of Quaternary ammonium compounds, benzyl-C12-C16-alkyldimethyl, chlorides 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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