01 1Kongo Chemical Co., Ltd.
01 1Diphenhydramine hydrochloride (production only)
01 1Japan
Diphenhydramine hydrochloride (for manufacturing purposes only)
Registration Number : 217MF11188
Registrant's Address : 3 Himata, Toyama City, Toyama Prefecture
Initial Date of Registration : 2005-12-12
Latest Date of Registration : 2010-03-09
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A Cathejell manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cathejell, including repackagers and relabelers. The FDA regulates Cathejell manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cathejell 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 Cathejell manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Cathejell supplier is an individual or a company that provides Cathejell active pharmaceutical ingredient (API) or Cathejell finished formulations upon request. The Cathejell suppliers may include Cathejell API manufacturers, exporters, distributors and traders.
click here to find a list of Cathejell 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 Cathejell Drug Master File in Japan (Cathejell JDMF) empowers Cathejell 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 Cathejell JDMF during the approval evaluation for pharmaceutical products. At the time of Cathejell 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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