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