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