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