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