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