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