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