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