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