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