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