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