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