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