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