01 1Shiono Finesse Co., Ltd.
01 1bepridil hydrochloride hydrate
01 1Japan
Bepridil hydrochloride hydrate
Registration Number : 304MF10114
Registrant's Address : Osaka Prefecture, Osaka City, Chuo Ward, Doshomachi 3-1-6
Initial Date of Registration : 2022-08-03
Latest Date of Registration : 2022-08-03
A Bepridil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bepridil, including repackagers and relabelers. The FDA regulates Bepridil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bepridil 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 Bepridil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bepridil supplier is an individual or a company that provides Bepridil active pharmaceutical ingredient (API) or Bepridil finished formulations upon request. The Bepridil suppliers may include Bepridil API manufacturers, exporters, distributors and traders.
click here to find a list of Bepridil 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 Bepridil Drug Master File in Japan (Bepridil JDMF) empowers Bepridil 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 Bepridil JDMF during the approval evaluation for pharmaceutical products. At the time of Bepridil 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 Bepridil suppliers with JDMF on PharmaCompass.
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