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