01 1Shiono Finesse Co., Ltd.
01 1Isoproterenol hydrochloride
01 1Japan
Registration Number : 220MF10065
Registrant's Address : 3-1-6 Doshomachi, Chuo-ku, Osaka City, Osaka Prefecture
Initial Date of Registration : 2008-02-25
Latest Date of Registration : 2008-02-25
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A Isadrin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isadrin, including repackagers and relabelers. The FDA regulates Isadrin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isadrin 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 Isadrin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Isadrin supplier is an individual or a company that provides Isadrin active pharmaceutical ingredient (API) or Isadrin finished formulations upon request. The Isadrin suppliers may include Isadrin API manufacturers, exporters, distributors and traders.
click here to find a list of Isadrin 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 Isadrin Drug Master File in Japan (Isadrin JDMF) empowers Isadrin 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 Isadrin JDMF during the approval evaluation for pharmaceutical products. At the time of Isadrin 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 Isadrin suppliers with JDMF on PharmaCompass.
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