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