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