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