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