In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Calcidar 40 Drug Master File in Korea (Calcidar 40 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Calcidar 40. The MFDS reviews the Calcidar 40 KDMF as part of the drug registration process and uses the information provided in the Calcidar 40 KDMF to evaluate the safety and efficacy of the drug.
After submitting a Calcidar 40 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 Calcidar 40 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Calcidar 40 suppliers with KDMF on PharmaCompass.