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 2-(diphenylmethoxy)-N,N-dimethylethanamine hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 2-(diphenylmethoxy)-N,N-dimethylethanamine hydrochloride, including repackagers and relabelers. The FDA regulates 2-(diphenylmethoxy)-N,N-dimethylethanamine hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 2-(diphenylmethoxy)-N,N-dimethylethanamine 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 2-(diphenylmethoxy)-N,N-dimethylethanamine hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A 2-(diphenylmethoxy)-N,N-dimethylethanamine hydrochloride supplier is an individual or a company that provides 2-(diphenylmethoxy)-N,N-dimethylethanamine hydrochloride active pharmaceutical ingredient (API) or 2-(diphenylmethoxy)-N,N-dimethylethanamine hydrochloride finished formulations upon request. The 2-(diphenylmethoxy)-N,N-dimethylethanamine hydrochloride suppliers may include 2-(diphenylmethoxy)-N,N-dimethylethanamine hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of 2-(diphenylmethoxy)-N,N-dimethylethanamine hydrochloride 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 2-(diphenylmethoxy)-N,N-dimethylethanamine hydrochloride Drug Master File in Japan (2-(diphenylmethoxy)-N,N-dimethylethanamine hydrochloride JDMF) empowers 2-(diphenylmethoxy)-N,N-dimethylethanamine 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 2-(diphenylmethoxy)-N,N-dimethylethanamine hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of 2-(diphenylmethoxy)-N,N-dimethylethanamine 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 2-(diphenylmethoxy)-N,N-dimethylethanamine hydrochloride suppliers with JDMF on PharmaCompass.
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