In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a CI 366 Drug Master File in Korea (CI 366 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of CI 366. The MFDS reviews the CI 366 KDMF as part of the drug registration process and uses the information provided in the CI 366 KDMF to evaluate the safety and efficacy of the drug.
After submitting a CI 366 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 CI 366 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of CI 366 suppliers with KDMF on PharmaCompass.