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