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