01 1Kyorin Pharmaceutical Group Factory Co., Ltd.
01 1Gatifloxacin
01 1Japan
Registration Number : 218MF10335
Registrant's Address : 6 Kanda Surugadai 4-chome, Chiyoda-ku, Tokyo
Initial Date of Registration : 2006-03-09
Latest Date of Registration : 2009-07-09
A Gatifloxacin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gatifloxacin, including repackagers and relabelers. The FDA regulates Gatifloxacin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gatifloxacin 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 Gatifloxacin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gatifloxacin supplier is an individual or a company that provides Gatifloxacin active pharmaceutical ingredient (API) or Gatifloxacin finished formulations upon request. The Gatifloxacin suppliers may include Gatifloxacin API manufacturers, exporters, distributors and traders.
click here to find a list of Gatifloxacin 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 Gatifloxacin Drug Master File in Japan (Gatifloxacin JDMF) empowers Gatifloxacin 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 Gatifloxacin JDMF during the approval evaluation for pharmaceutical products. At the time of Gatifloxacin 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 Gatifloxacin suppliers with JDMF on PharmaCompass.
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