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