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