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