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