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