01 2Kongo Chemical Co., Ltd.
01 1Diphenhydramine (production only)
02 1Salicylic acid diphenhydramine (production only)
01 2Japan
Diphenhydramine Salicylate (for manufacturing purposes only)
Registration Number : 217MF11205
Registrant's Address : 3 Himata, Toyama City, Toyama Prefecture
Initial Date of Registration : 2005-12-12
Latest Date of Registration : 2010-03-09
Diphenhydramine (for manufacturing purposes only)
Registration Number : 217MF11191
Registrant's Address : 3 Himata, Toyama City, Toyama Prefecture
Initial Date of Registration : 2005-12-12
Latest Date of Registration : 2021-04-13
A Diphenhydramine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Diphenhydramine, including repackagers and relabelers. The FDA regulates Diphenhydramine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Diphenhydramine 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 Diphenhydramine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Diphenhydramine supplier is an individual or a company that provides Diphenhydramine active pharmaceutical ingredient (API) or Diphenhydramine finished formulations upon request. The Diphenhydramine suppliers may include Diphenhydramine API manufacturers, exporters, distributors and traders.
click here to find a list of Diphenhydramine 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 Diphenhydramine Drug Master File in Japan (Diphenhydramine JDMF) empowers Diphenhydramine 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 Diphenhydramine JDMF during the approval evaluation for pharmaceutical products. At the time of Diphenhydramine 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 Diphenhydramine suppliers with JDMF on PharmaCompass.
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