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