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