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