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