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 Regutol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Regutol, including repackagers and relabelers. The FDA regulates Regutol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Regutol 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 Regutol supplier is an individual or a company that provides Regutol active pharmaceutical ingredient (API) or Regutol finished formulations upon request. The Regutol suppliers may include Regutol 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 Regutol Drug Master File in Japan (Regutol JDMF) empowers Regutol 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 Regutol JDMF during the approval evaluation for pharmaceutical products. At the time of Regutol 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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