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