01 1Kyorin Pharmaceutical Group Facilities Co., Ltd. Noshiro Plant
01 1Handok Co., Ltd.
01 1Gatifloxacin 1.5 hydrate
01 1Japan
Registrant Name : Handok Co., Ltd.
Registration Date : 2013-05-07
Registration Number : 20130507-174-I-282-01
Manufacturer Name : Kyorin Pharmaceutical Group ...
Manufacturer Address : 1, Matsubara, Noshiro-shi, Akita, 016-0000, Japan
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.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Gatifloxacin Drug Master File in Korea (Gatifloxacin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Gatifloxacin. The MFDS reviews the Gatifloxacin KDMF as part of the drug registration process and uses the information provided in the Gatifloxacin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Gatifloxacin KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Gatifloxacin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Gatifloxacin suppliers with KDMF on PharmaCompass.
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