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