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