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