01 1Permakem Asia Co., Ltd.
01 1Aldioxa
01 1Japan
Registration Number : 217MF10704
Registrant's Address : 1-10-11, Nihonbashi Horidomecho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-10-07
Latest Date of Registration : 2023-10-25
A Isalon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isalon, including repackagers and relabelers. The FDA regulates Isalon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isalon 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 Isalon supplier is an individual or a company that provides Isalon active pharmaceutical ingredient (API) or Isalon finished formulations upon request. The Isalon suppliers may include Isalon API manufacturers, exporters, distributors and traders.
click here to find a list of Isalon 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 Isalon Drug Master File in Japan (Isalon JDMF) empowers Isalon 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 Isalon JDMF during the approval evaluation for pharmaceutical products. At the time of Isalon 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 Isalon suppliers with JDMF on PharmaCompass.
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