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