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