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