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