In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a CCRIS 6054 Drug Master File in Korea (CCRIS 6054 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of CCRIS 6054. The MFDS reviews the CCRIS 6054 KDMF as part of the drug registration process and uses the information provided in the CCRIS 6054 KDMF to evaluate the safety and efficacy of the drug.
After submitting a CCRIS 6054 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 CCRIS 6054 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of CCRIS 6054 suppliers with KDMF on PharmaCompass.