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