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