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