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