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 Cresemba manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cresemba, including repackagers and relabelers. The FDA regulates Cresemba manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cresemba API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Cresemba supplier is an individual or a company that provides Cresemba active pharmaceutical ingredient (API) or Cresemba finished formulations upon request. The Cresemba suppliers may include Cresemba API manufacturers, exporters, distributors and traders.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Cresemba Drug Master File in Korea (Cresemba KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cresemba. The MFDS reviews the Cresemba KDMF as part of the drug registration process and uses the information provided in the Cresemba KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cresemba 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 Cresemba API can apply through the Korea Drug Master File (KDMF).
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