01 1Juzen Chemical Co., Ltd.
01 1Prulifloxacin JZ
01 1Japan
Registration Number : 217MF10007
Registrant's Address : 1-10 Kibacho, Toyama City, Toyama Prefecture
Initial Date of Registration : 2005-05-18
Latest Date of Registration : 2010-10-06
A Prulifloxacin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prulifloxacin, including repackagers and relabelers. The FDA regulates Prulifloxacin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prulifloxacin 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 Prulifloxacin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Prulifloxacin supplier is an individual or a company that provides Prulifloxacin active pharmaceutical ingredient (API) or Prulifloxacin finished formulations upon request. The Prulifloxacin suppliers may include Prulifloxacin API manufacturers, exporters, distributors and traders.
click here to find a list of Prulifloxacin 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 Prulifloxacin Drug Master File in Japan (Prulifloxacin JDMF) empowers Prulifloxacin 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 Prulifloxacin JDMF during the approval evaluation for pharmaceutical products. At the time of Prulifloxacin 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 Prulifloxacin suppliers with JDMF on PharmaCompass.
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