In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a NS 400 Drug Master File in Korea (NS 400 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of NS 400. The MFDS reviews the NS 400 KDMF as part of the drug registration process and uses the information provided in the NS 400 KDMF to evaluate the safety and efficacy of the drug.
After submitting a NS 400 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 NS 400 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of NS 400 suppliers with KDMF on PharmaCompass.