In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Ex4 Drug Master File in Korea (Ex4 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ex4. The MFDS reviews the Ex4 KDMF as part of the drug registration process and uses the information provided in the Ex4 KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ex4 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 Ex4 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ex4 suppliers with KDMF on PharmaCompass.