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