01 1Hovione FarmaCiencia SA
01 1Pfizer Korea
01 1Isabuconazonium sulfate
01 1Portugal
Registrant Name : Pfizer Korea
Registration Date : 2020-01-29
Registration Number : Su87-26-ND
Manufacturer Name : Hovione FarmaCiencia SA
Manufacturer Address : Sete Casas, Loures, 2674-506, Portugal
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A Isavuconazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isavuconazole, including repackagers and relabelers. The FDA regulates Isavuconazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isavuconazole 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 Isavuconazole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Isavuconazole supplier is an individual or a company that provides Isavuconazole active pharmaceutical ingredient (API) or Isavuconazole finished formulations upon request. The Isavuconazole suppliers may include Isavuconazole API manufacturers, exporters, distributors and traders.
click here to find a list of Isavuconazole 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 Isavuconazole Drug Master File in Korea (Isavuconazole KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Isavuconazole. The MFDS reviews the Isavuconazole KDMF as part of the drug registration process and uses the information provided in the Isavuconazole KDMF to evaluate the safety and efficacy of the drug.
After submitting a Isavuconazole 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 Isavuconazole API can apply through the Korea Drug Master File (KDMF).
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