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