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