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