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