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 anhydrous manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of gatifloxacin anhydrous, including repackagers and relabelers. The FDA regulates gatifloxacin anhydrous manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. gatifloxacin anhydrous 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 anhydrous manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A gatifloxacin anhydrous supplier is an individual or a company that provides gatifloxacin anhydrous active pharmaceutical ingredient (API) or gatifloxacin anhydrous finished formulations upon request. The gatifloxacin anhydrous suppliers may include gatifloxacin anhydrous API manufacturers, exporters, distributors and traders.
click here to find a list of gatifloxacin anhydrous 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 anhydrous Drug Master File in Japan (gatifloxacin anhydrous JDMF) empowers gatifloxacin anhydrous 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 anhydrous JDMF during the approval evaluation for pharmaceutical products. At the time of gatifloxacin anhydrous 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 anhydrous suppliers with JDMF on PharmaCompass.
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