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