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