01 1Katwijk Chemie bv
02 1Shizuoka Caffeine Industry Co., Ltd.
01 2Japanese Pharmacopoeia phenytoin (production only)
01 1Japan
02 1Netherlands
Japanese Pharmacopoeia Phenytoin (for manufacturing purposes only)
Registration Number : 218MF10527
Registrant's Address : Snijderstraat 6,2222 BA, Katwijk, ZH The Netherlands
Initial Date of Registration : 2006-05-18
Latest Date of Registration : 2006-05-18
Japanese Pharmacopoeia Phenytoin (for manufacturing purposes only)
Registration Number : 217MF10615
Registrant's Address : 129 Suidocho, Aoi Ward, Shizuoka City, Shizuoka Prefecture
Initial Date of Registration : 2005-09-14
Latest Date of Registration : 2008-05-29
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PharmaCompass offers a list of Phenytoin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Phenytoin manufacturer or Phenytoin supplier for your needs.
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A UNII-6158TKW0C5 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of UNII-6158TKW0C5, including repackagers and relabelers. The FDA regulates UNII-6158TKW0C5 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. UNII-6158TKW0C5 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 UNII-6158TKW0C5 supplier is an individual or a company that provides UNII-6158TKW0C5 active pharmaceutical ingredient (API) or UNII-6158TKW0C5 finished formulations upon request. The UNII-6158TKW0C5 suppliers may include UNII-6158TKW0C5 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 UNII-6158TKW0C5 Drug Master File in Japan (UNII-6158TKW0C5 JDMF) empowers UNII-6158TKW0C5 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 UNII-6158TKW0C5 JDMF during the approval evaluation for pharmaceutical products. At the time of UNII-6158TKW0C5 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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