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