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 Folcal DHA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Folcal DHA, including repackagers and relabelers. The FDA regulates Folcal DHA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Folcal DHA 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 Folcal DHA supplier is an individual or a company that provides Folcal DHA active pharmaceutical ingredient (API) or Folcal DHA finished formulations upon request. The Folcal DHA suppliers may include Folcal DHA API manufacturers, exporters, distributors and traders.
click here to find a list of Folcal DHA suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
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 Folcal DHA Drug Master File in Japan (Folcal DHA JDMF) empowers Folcal DHA 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 Folcal DHA JDMF during the approval evaluation for pharmaceutical products. At the time of Folcal DHA 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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