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