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