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