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