In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a B12, Vitamin Drug Master File in Korea (B12, Vitamin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of B12, Vitamin. The MFDS reviews the B12, Vitamin KDMF as part of the drug registration process and uses the information provided in the B12, Vitamin KDMF to evaluate the safety and efficacy of the drug.
After submitting a B12, Vitamin 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 B12, Vitamin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of B12, Vitamin suppliers with KDMF on PharmaCompass.