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