In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a D00456 Drug Master File in Korea (D00456 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of D00456. The MFDS reviews the D00456 KDMF as part of the drug registration process and uses the information provided in the D00456 KDMF to evaluate the safety and efficacy of the drug.
After submitting a D00456 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 D00456 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of D00456 suppliers with KDMF on PharmaCompass.