In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Itraconazole, Sporanox Drug Master File in Korea (Itraconazole, Sporanox KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Itraconazole, Sporanox. The MFDS reviews the Itraconazole, Sporanox KDMF as part of the drug registration process and uses the information provided in the Itraconazole, Sporanox KDMF to evaluate the safety and efficacy of the drug.
After submitting a Itraconazole, Sporanox 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 Itraconazole, Sporanox API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Itraconazole, Sporanox suppliers with KDMF on PharmaCompass.