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