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