In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Mecobalamin(Methyl-5,6-dimethylbenzimidazolylcobalamin; Vitamin B12) Drug Master File in Korea (Mecobalamin(Methyl-5,6-dimethylbenzimidazolylcobalamin; Vitamin B12) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Mecobalamin(Methyl-5,6-dimethylbenzimidazolylcobalamin; Vitamin B12). The MFDS reviews the Mecobalamin(Methyl-5,6-dimethylbenzimidazolylcobalamin; Vitamin B12) KDMF as part of the drug registration process and uses the information provided in the Mecobalamin(Methyl-5,6-dimethylbenzimidazolylcobalamin; Vitamin B12) KDMF to evaluate the safety and efficacy of the drug.
After submitting a Mecobalamin(Methyl-5,6-dimethylbenzimidazolylcobalamin; Vitamin B12) 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 Mecobalamin(Methyl-5,6-dimethylbenzimidazolylcobalamin; Vitamin B12) API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Mecobalamin(Methyl-5,6-dimethylbenzimidazolylcobalamin; Vitamin B12) suppliers with KDMF on PharmaCompass.