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