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