01 1Katsura Chemical Co., Ltd.
01 1Pre-di Nord mesylate
01 1Japan
Registration Number : 219MF10240
Registrant's Address : 4-15-19 Hibarigaoka, Zama City, Kanagawa Prefecture
Initial Date of Registration : 2007-07-17
Latest Date of Registration : 2007-07-17
A Pridinol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pridinol, including repackagers and relabelers. The FDA regulates Pridinol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pridinol 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 Pridinol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pridinol supplier is an individual or a company that provides Pridinol active pharmaceutical ingredient (API) or Pridinol finished formulations upon request. The Pridinol suppliers may include Pridinol API manufacturers, exporters, distributors and traders.
click here to find a list of Pridinol 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 Pridinol Drug Master File in Japan (Pridinol JDMF) empowers Pridinol 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 Pridinol JDMF during the approval evaluation for pharmaceutical products. At the time of Pridinol 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 Pridinol suppliers with JDMF on PharmaCompass.
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