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