01 4Fuji Chemical Industry Co., Ltd.
01 1Magnesium aluminometasilicate (FH1) (production only)
02 1Magnesium aluminometasilicate (S1) (production only)
03 1Magnesium aluminometasilicate (S2) (production only)
04 1Undried magnesium aluminometasilicate
01 4Japan
Undried magnesium aluminometasilicate
Registration Number : 218MF10858
Registrant's Address : 55 Yokohoonji, Kamiichi-cho, Nakaniikawa-gun, Toyama Prefecture
Initial Date of Registration : 2006-11-06
Latest Date of Registration : 2006-11-06
Magnesium aluminometasilicate (S1) (for manufacturing purposes only)
Registration Number : 221MF10096
Registrant's Address : 55 Yokohoonji, Kamiichi-cho, Nakaniikawa-gun, Toyama Prefecture
Initial Date of Registration : 2009-05-13
Latest Date of Registration : 2009-05-13
Magnesium aluminometasilicate (FH1) (for manufacturing purposes only)
Registration Number : 221MF10095
Registrant's Address : 55 Yokohoonji, Kamiichi-cho, Nakaniikawa-gun, Toyama Prefecture
Initial Date of Registration : 2009-05-13
Latest Date of Registration : 2009-05-13
Magnesium aluminometasilicate (S2) (for manufacturing purposes only)
Registration Number : 221MF10093
Registrant's Address : 55 Yokohoonji, Kamiichi-cho, Nakaniikawa-gun, Toyama Prefecture
Initial Date of Registration : 2009-05-13
Latest Date of Registration : 2009-05-13
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A Magnesium aluminum silicate (MgAl2(SiO4)2) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Magnesium aluminum silicate (MgAl2(SiO4)2), including repackagers and relabelers. The FDA regulates Magnesium aluminum silicate (MgAl2(SiO4)2) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Magnesium aluminum silicate (MgAl2(SiO4)2) API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Magnesium aluminum silicate (MgAl2(SiO4)2) supplier is an individual or a company that provides Magnesium aluminum silicate (MgAl2(SiO4)2) active pharmaceutical ingredient (API) or Magnesium aluminum silicate (MgAl2(SiO4)2) finished formulations upon request. The Magnesium aluminum silicate (MgAl2(SiO4)2) suppliers may include Magnesium aluminum silicate (MgAl2(SiO4)2) 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 Magnesium aluminum silicate (MgAl2(SiO4)2) Drug Master File in Japan (Magnesium aluminum silicate (MgAl2(SiO4)2) JDMF) empowers Magnesium aluminum silicate (MgAl2(SiO4)2) 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 Magnesium aluminum silicate (MgAl2(SiO4)2) JDMF during the approval evaluation for pharmaceutical products. At the time of Magnesium aluminum silicate (MgAl2(SiO4)2) 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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