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