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