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