01 1Speranexus Co., Ltd.
01 1Oxaprozin
01 1Japan
Registration Number : 217MF10040
Registrant's Address : 4-8-2 Nihonbashi Honcho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-05-20
Latest Date of Registration : 2009-11-24
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A NCGC00014711 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of NCGC00014711, including repackagers and relabelers. The FDA regulates NCGC00014711 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. NCGC00014711 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of NCGC00014711 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A NCGC00014711 supplier is an individual or a company that provides NCGC00014711 active pharmaceutical ingredient (API) or NCGC00014711 finished formulations upon request. The NCGC00014711 suppliers may include NCGC00014711 API manufacturers, exporters, distributors and traders.
click here to find a list of NCGC00014711 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
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 NCGC00014711 Drug Master File in Japan (NCGC00014711 JDMF) empowers NCGC00014711 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 NCGC00014711 JDMF during the approval evaluation for pharmaceutical products. At the time of NCGC00014711 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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