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