01 1Kyowa Hakko Bio Co., Ltd.
02 1TOA EIYO Co., Ltd.
01 1Flavin adenine dinucleotide sodium
02 1Japanese Pharmacopoeia flavin adenine dinucleotide sodium (production only)
01 2Japan
Japanese Pharmacopoeia Flavin Adenine Dinucleotide Sodium (For manufacturing only)
Registration Number : 217MF10264
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-06-15
Latest Date of Registration : 2006-06-09
Flavin Adenine Dinucleotide Sodium
Registration Number : 217MF10550
Registrant's Address : 3-1-2 Kyobashi, Chuo-ku, Tokyo
Initial Date of Registration : 2005-09-09
Latest Date of Registration : 2007-03-14
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A 102029-93-6 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 102029-93-6, including repackagers and relabelers. The FDA regulates 102029-93-6 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 102029-93-6 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 102029-93-6 supplier is an individual or a company that provides 102029-93-6 active pharmaceutical ingredient (API) or 102029-93-6 finished formulations upon request. The 102029-93-6 suppliers may include 102029-93-6 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 102029-93-6 Drug Master File in Japan (102029-93-6 JDMF) empowers 102029-93-6 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 102029-93-6 JDMF during the approval evaluation for pharmaceutical products. At the time of 102029-93-6 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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