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