01 1Cytec Industries Inc.
01 1Outsider regulations dioctyl sodium sulfosuccinate (manufactured only)
01 1Belgium
Non-regulated 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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PharmaCompass offers a list of Docusate Sodium 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 Docusate Sodium manufacturer or Docusate Sodium supplier for your needs.
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A Docuprene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Docuprene, including repackagers and relabelers. The FDA regulates Docuprene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Docuprene 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 Docuprene supplier is an individual or a company that provides Docuprene active pharmaceutical ingredient (API) or Docuprene finished formulations upon request. The Docuprene suppliers may include Docuprene 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 Docuprene Drug Master File in Japan (Docuprene JDMF) empowers Docuprene 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 Docuprene JDMF during the approval evaluation for pharmaceutical products. At the time of Docuprene 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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