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