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