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