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