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 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 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
A Phenytoin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Phenytoin, including repackagers and relabelers. The FDA regulates Phenytoin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Phenytoin 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 Phenytoin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Phenytoin supplier is an individual or a company that provides Phenytoin active pharmaceutical ingredient (API) or Phenytoin finished formulations upon request. The Phenytoin suppliers may include Phenytoin API manufacturers, exporters, distributors and traders.
click here to find a list of Phenytoin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price 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 Phenytoin Drug Master File in Japan (Phenytoin JDMF) empowers Phenytoin 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 Phenytoin JDMF during the approval evaluation for pharmaceutical products. At the time of Phenytoin JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Phenytoin suppliers with JDMF on PharmaCompass.
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