01 1Astellas Pharma Inc. Toyama Technology Center
01 1Astellas Pharma Korea Co., Ltd.
01 1Mica fungine sodium
01 1Japan
Registrant Name : Astellas Pharma Korea Co., Ltd.
Registration Date : 2006-05-11
Registration Number : Number 118-1-ND
Manufacturer Name : Astellas Pharma Inc. Toyama ...
Manufacturer Address : 2-178, Kojin-machi, Toyama-city, Toyama 930-0809, Japan (3-11, Nihenbashi-honcho 2cho...
A Micafungin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Micafungin, including repackagers and relabelers. The FDA regulates Micafungin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Micafungin 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 Micafungin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Micafungin supplier is an individual or a company that provides Micafungin active pharmaceutical ingredient (API) or Micafungin finished formulations upon request. The Micafungin suppliers may include Micafungin API manufacturers, exporters, distributors and traders.
click here to find a list of Micafungin 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 Micafungin Drug Master File in Korea (Micafungin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Micafungin. The MFDS reviews the Micafungin KDMF as part of the drug registration process and uses the information provided in the Micafungin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Micafungin 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 Micafungin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Micafungin suppliers with KDMF on PharmaCompass.
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