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