01 1Yanagishima Pharmaceutical Co., Ltd.
01 1Potassium iodide (production only)
01 1Blank
Potassium iodide (for manufacturing purposes only)
Registration Number : 218MF10333
Registrant's Address : 1-5-17 Nihonbashi Honcho, Chuo-ku, Tokyo
Initial Date of Registration : 2006-03-09
Latest Date of Registration : 2010-04-12
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A Iosat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Iosat, including repackagers and relabelers. The FDA regulates Iosat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Iosat 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 Iosat supplier is an individual or a company that provides Iosat active pharmaceutical ingredient (API) or Iosat finished formulations upon request. The Iosat suppliers may include Iosat 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 Iosat Drug Master File in Japan (Iosat JDMF) empowers Iosat 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 Iosat JDMF during the approval evaluation for pharmaceutical products. At the time of Iosat 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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