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