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