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