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