01 1Hamari PFST Co., Ltd.
01 1Porapurejinku "hamari Y"
01 1Japan
Registration Number : 217MF10860
Registrant's Address : Osaka Prefecture, Osaka City, Suminoe Ward, Nanko Kita 1-19-40
Initial Date of Registration : 2005-11-01
Latest Date of Registration : 2007-03-05
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A NCGC00181764-01 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of NCGC00181764-01, including repackagers and relabelers. The FDA regulates NCGC00181764-01 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. NCGC00181764-01 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 NCGC00181764-01 supplier is an individual or a company that provides NCGC00181764-01 active pharmaceutical ingredient (API) or NCGC00181764-01 finished formulations upon request. The NCGC00181764-01 suppliers may include NCGC00181764-01 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 NCGC00181764-01 Drug Master File in Japan (NCGC00181764-01 JDMF) empowers NCGC00181764-01 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 NCGC00181764-01 JDMF during the approval evaluation for pharmaceutical products. At the time of NCGC00181764-01 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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