01 1Cytec Industries Inc.
01 1Outsider regulations dioctyl sodium sulfosuccinate (manufactured only)
01 1Belgium
Dioctyl sodium sulfosuccinate (for manufacturing purposes only)
Registration Number : 218MF10083
Registrant's Address : 504 Carnegie Center, Princeton, NJ 08540, U.S. S. A.
Initial Date of Registration : 2006-01-27
Latest Date of Registration : 2010-03-19
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A Solusol-100% manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Solusol-100%, including repackagers and relabelers. The FDA regulates Solusol-100% manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Solusol-100% 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 Solusol-100% supplier is an individual or a company that provides Solusol-100% active pharmaceutical ingredient (API) or Solusol-100% finished formulations upon request. The Solusol-100% suppliers may include Solusol-100% 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 Solusol-100% Drug Master File in Japan (Solusol-100% JDMF) empowers Solusol-100% 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 Solusol-100% JDMF during the approval evaluation for pharmaceutical products. At the time of Solusol-100% 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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