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