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