01 1Hokko Chemical Industry Co., Ltd.
02 1Midori Chemical Co., Ltd.
01 1Hydrochloric acid difenidol
02 1Japanese Pharmacopoeia difenidol hydrochloride (production only)
01 2Japan
Japanese Pharmacopoeia Diphenidol Hydrochloride (For manufacturing only)
Registration Number : 219MF10298
Registrant's Address : 4-4-20 Honjocho, Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2007-09-18
Latest Date of Registration : 2007-09-18
Registration Number : 217MF11280
Registrant's Address : 2-9-16 Nishiochiai, Shinjuku-ku, Tokyo
Initial Date of Registration : 2005-12-20
Latest Date of Registration : 2022-01-11
A Diphenidol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Diphenidol, including repackagers and relabelers. The FDA regulates Diphenidol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Diphenidol API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Diphenidol supplier is an individual or a company that provides Diphenidol active pharmaceutical ingredient (API) or Diphenidol finished formulations upon request. The Diphenidol suppliers may include Diphenidol API manufacturers, exporters, distributors and traders.
click here to find a list of Diphenidol 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 Diphenidol Drug Master File in Japan (Diphenidol JDMF) empowers Diphenidol 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 Diphenidol JDMF during the approval evaluation for pharmaceutical products. At the time of Diphenidol 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 Diphenidol suppliers with JDMF on PharmaCompass.
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