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