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