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