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