01 1Katwijk Chemie bv
02 1Shizuoka Caffeine Industrial 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 Suido-cho, Aoi-ku, 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, and more, enabling you to easily find the right Phenytoin manufacturer or Phenytoin supplier for your needs.
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A Di-Hydan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Di-Hydan, including repackagers and relabelers. The FDA regulates Di-Hydan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Di-Hydan 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 Di-Hydan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Di-Hydan supplier is an individual or a company that provides Di-Hydan active pharmaceutical ingredient (API) or Di-Hydan finished formulations upon request. The Di-Hydan suppliers may include Di-Hydan API manufacturers, exporters, distributors and traders.
click here to find a list of Di-Hydan 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 Di-Hydan Drug Master File in Japan (Di-Hydan JDMF) empowers Di-Hydan 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 Di-Hydan JDMF during the approval evaluation for pharmaceutical products. At the time of Di-Hydan 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 Di-Hydan suppliers with JDMF on PharmaCompass.
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