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
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A Zymaxid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zymaxid, including repackagers and relabelers. The FDA regulates Zymaxid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zymaxid 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 Zymaxid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Zymaxid supplier is an individual or a company that provides Zymaxid active pharmaceutical ingredient (API) or Zymaxid finished formulations upon request. The Zymaxid suppliers may include Zymaxid API manufacturers, exporters, distributors and traders.
click here to find a list of Zymaxid suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 Zymaxid Drug Master File in Korea (Zymaxid KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Zymaxid. The MFDS reviews the Zymaxid KDMF as part of the drug registration process and uses the information provided in the Zymaxid KDMF to evaluate the safety and efficacy of the drug.
After submitting a Zymaxid 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 Zymaxid API can apply through the Korea Drug Master File (KDMF).
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