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