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