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