In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a NS 100 Drug Master File in Korea (NS 100 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of NS 100. The MFDS reviews the NS 100 KDMF as part of the drug registration process and uses the information provided in the NS 100 KDMF to evaluate the safety and efficacy of the drug.
After submitting a NS 100 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 100 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of NS 100 suppliers with KDMF on PharmaCompass.