01 1Yanagishima Pharmaceutical Co., Ltd.
01 1Sodium iodide (production only)
01 1Blank
Sodium iodide (for manufacturing purposes only)
Registration Number : 218MF10332
Registrant's Address : 1-14 Hirai 3-chome, Edogawa-ku, Tokyo
Initial Date of Registration : 2006-03-09
Latest Date of Registration : 2010-04-13
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A 03129_SIAL manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 03129_SIAL, including repackagers and relabelers. The FDA regulates 03129_SIAL manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 03129_SIAL 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 03129_SIAL supplier is an individual or a company that provides 03129_SIAL active pharmaceutical ingredient (API) or 03129_SIAL finished formulations upon request. The 03129_SIAL suppliers may include 03129_SIAL 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 03129_SIAL Drug Master File in Japan (03129_SIAL JDMF) empowers 03129_SIAL 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 03129_SIAL JDMF during the approval evaluation for pharmaceutical products. At the time of 03129_SIAL 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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