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