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