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