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