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