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