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