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