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