01 1Organic Synthesis Chemicals Co., Ltd.
01 1Fudostein "Yuki"
01 1Japan
Registration Number : 217MF10816
Registrant's Address : 3-10-4 Nihonbashi Ningyocho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-11-01
Latest Date of Registration : 2008-09-29
A Fudosteine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fudosteine, including repackagers and relabelers. The FDA regulates Fudosteine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fudosteine 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 Fudosteine supplier is an individual or a company that provides Fudosteine active pharmaceutical ingredient (API) or Fudosteine finished formulations upon request. The Fudosteine suppliers may include Fudosteine API manufacturers, exporters, distributors and traders.
click here to find a list of Fudosteine 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 Fudosteine Drug Master File in Japan (Fudosteine JDMF) empowers Fudosteine 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 Fudosteine JDMF during the approval evaluation for pharmaceutical products. At the time of Fudosteine 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 Fudosteine suppliers with JDMF on PharmaCompass.
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