01 2Kyowa Chemical Industry Co., Ltd.
01 2Japanese Pharmacopoeia magnesium carbonate (production only)
01 2Japan
Japanese Pharmacopoeia Magnesium Carbonate (for manufacturing purposes only)
Registration Number : 221MF10226
Registrant's Address : 305 Yashima Nishimachi, Takamatsu City, Kagawa Prefecture
Initial Date of Registration : 2009-10-19
Latest Date of Registration : 2025-04-08
Japanese Pharmacopoeia Magnesium Carbonate (for manufacturing purposes only)
Registration Number : 221MF10225
Registrant's Address : 305 Yashima Nishimachi, Takamatsu City, Kagawa Prefecture
Initial Date of Registration : 2009-10-19
Latest Date of Registration : 2024-12-25
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A Magfy manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Magfy, including repackagers and relabelers. The FDA regulates Magfy manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Magfy 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 Magfy supplier is an individual or a company that provides Magfy active pharmaceutical ingredient (API) or Magfy finished formulations upon request. The Magfy suppliers may include Magfy 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 Magfy Drug Master File in Japan (Magfy JDMF) empowers Magfy 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 Magfy JDMF during the approval evaluation for pharmaceutical products. At the time of Magfy 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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