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