In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Riboflavin (Vit B2) Drug Master File in Korea (Riboflavin (Vit B2) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Riboflavin (Vit B2). The MFDS reviews the Riboflavin (Vit B2) KDMF as part of the drug registration process and uses the information provided in the Riboflavin (Vit B2) KDMF to evaluate the safety and efficacy of the drug.
After submitting a Riboflavin (Vit B2) 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 (Vit B2) API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Riboflavin (Vit B2) suppliers with KDMF on PharmaCompass.