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