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