In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a CaCO3 Drug Master File in Korea (CaCO3 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of CaCO3. The MFDS reviews the CaCO3 KDMF as part of the drug registration process and uses the information provided in the CaCO3 KDMF to evaluate the safety and efficacy of the drug.
After submitting a CaCO3 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 CaCO3 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of CaCO3 suppliers with KDMF on PharmaCompass.