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