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